Last update 04 Nov 2024

Lidocaine

Last update 04 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryLidocaine，the first amino amide–type local anesthetic (previous were amino esters),as opposed to the amino ester-type local anesthetics that were used before it, was originally called "xylocaine" . It works by blocking the sodium ion channels that are necessary for the initiation and conduction of nerve impulses. Lidocaine was first synthesized in 1943 by Nils Löfgren, a Swedish chemist. It was first marketed in 1947, and quickly became a widely used medication。It indicated for the treatment of Ventricular tachycardia, Anesthesia,Neuralgia, Postherpetic,Hyperemesis Gravidarum.

Drug Type

Small molecule drug

Synonyms

Lidocaine Carbonate, Lidocaine Hydrochloride, Lidocaine topical

+ [35]

Target

SCNA

Mechanism

SCNA blockers(Sodium channel alpha subunit blockers)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesUrogenital Diseases+ [6]

Active Indication

Neuralgia, PostherpeticPainVentricular Arrhythmia+ [11]

Inactive Indication

Chronic PainCoughMorton Neuroma

Originator Organization-

Active Organization

Beijing Tide Pharmaceutical Co., Ltd.China Center for Pharmaceutical International Exchange (CCPIE)

Icure Pharmaceutical Inc.

+ [12]

Inactive Organization

Grünenthal GmbH

GSK Plc

AstraZeneca PLC

+ [1]

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1947),

AnesthesiaTachycardia, Ventricular

RegulationPriority Review (CN), Fast Track (US)

Structure

Molecular FormulaC14H22N2O

InChIKeyNNJVILVZKWQKPM-UHFFFAOYSA-N

CAS Registry137-58-6

2,154

Clinical Trials associated with Lidocaine

NCT05729503 / Not yet recruitingPhase 2IIT

SPG Block Versus Placebo to Manage Anxiety at Electronic Dance Music Festivals

The goal of this clinical trial is to learn about the effect of a sphenopalatine ganglion (SPG) block in anxious patients at electronic dance music festivals. The main question is:
- Is an SPG block useful in reducing anxiety, in comparison to placebo?
Participants will have lidocaine-soaked cotton tip applicator placed inside each nare for 10-minutes, or have a saline-soaked cotton tip applicator placed inside each nare for 10-minutes.
Researchers compare the lidocaine-soaked intervention (SPG block) with the saline-soaked intervention (placebo) to see if it reduces anxiety in patients presenting at electronic dance music festivals with anxiety.

Start Date06 May 2026

Sponsor / Collaborator

University of Calgary

NCT06138041 / Not yet recruitingNot ApplicableIIT

Effect of Intravenous Lidocaine Infusion on Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy: a Double-center, Double-blind, Randomized Controlled Trial

The goal of this double-center, double-blind, randomized controlled clinical trial is to compare the effect of intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. The main question it aims to answer are whether intravenous lidocaine reduce postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. Participants will be given intravenous lidocaine infusion in lidocaine group or placebo in control group.

Start Date01 Feb 2025

Sponsor / Collaborator

Sichuan Cancer Hospital

CTRI/2024/03/063453 / Not yet recruitingPhase 2IIT

Comparison of the effect of intraoperative intravenous lidocaine and dexmedetomidine infusions on post-operative pain and recovery profile in spine surgeries – A Randomized non-inferiority trial. - --

Start Date08 Jan 2025

Sponsor / Collaborator

Jawaharlal Institute of Post Graduate Medical Education & Re

100 Clinical Results associated with Lidocaine

100 Translational Medicine associated with Lidocaine

100 Patents (Medical) associated with Lidocaine

29,009

Literatures (Medical) associated with Lidocaine

01 Jan 2025·THERIOGENOLOGY

Serial frequent or multiple Tru-cut® testicular biopsies in rams enable assessment of histological characteristics or transcriptional profiles, with no acute or chronic adverse effects

Article

Author: Rattes, P Z ; Pupulim, A.G.R. ; Kastelic, J.P. ; Pupulim, A G R ; Kastelic, J P ; Uzae, K Z ; Ribeiro, G.C. ; Nogueira, G P ; Mogollón García, H D ; Denadai, R ; Nunes, S G ; Ferreira, J C P ; Uzae, K.Z. ; Navolar, F.M.N. ; Di Santis, G.W. ; Nogueira, G.P. ; Rizzoto, G. ; Carvalho, J.C. ; Navolar, F M N ; Rattes, P.Z. ; Ferreira, J.C.P. ; Castilho, A C S ; Denadai, R. ; Ribeiro, G C ; Nunes, S.G. ; Rizzoto, G ; Mogollón García, H.D. ; Di Santis, G W ; Carvalho, J C ; Castilho, A.C.S.

This study aimed to evaluate the feasibility of performing multiple testicular biopsies in rams using Tru-cut® needles, assessing histological structure, gene expression, and potential complications such as effects on semen quality, testicular blood flow, and ultrasonographic echotexture. In Exp. 1, six mature rams underwent testicular biopsies at intervals (0, 3, 6, 12, 24, and 48 h) using a 16 G Tru-cut® needle, with alternating testes for each collection. Benzathine benzylpenicillin and flunixin meglumine were administered for infection and inflammation control. Local anesthesia and post-biopsy care included lidocaine, digital pressure, and ice application. Testicular samples were analyzed for gene expression related to inflammation, oxidative stress, and steroidogenesis. Semen quality was assessed pre-biopsy and 28 days post-biopsy. Ultrasonographic evaluations of the scrotum and testes were conducted before biopsies and on days 5, 9, 13, 17, and 21 post-biopsies. In Exp. 2, a second group of six mature rams underwent biopsies using 14 G needles, with two samples taken from each testis. Samples were histologically examined for structural preservation. Scrotal skin temperature was measured using infrared thermography, and testicular blood flow was assessed via color Doppler ultrasonography, with measurements taken before and on days 1, 2, 4, 6, 8, 10, 25, 50, 75, and 100 post-biopsies. Semen collection followed the same schedule as in Exp. 1. In Exp. 3, biopsies were performed on different testicular regions (upper, middle, lower) using 12 G, 14 G, and 16 G needles to compare structural preservation. Samples were histologically analyzed. No clinical signs of injury, inflammation, or fluid accumulation were observed. Scrotal pain, increased temperature, swelling, and bleeding were absent, and behavioral signs indicative of pain were not detected. Gene expression remained unchanged, and no significant alterations in seminal characteristics or testicular echogenicity were observed. A slight increase in resistivity and pulsatility indices was noted in Exp. 2. Biopsies with 14 G and 16 G needles resulted in structural disruptions, while 12 G needles better preserved testicular parenchyma. Multiple testicular biopsies using Tru-cut® needles did not cause significant morphological changes, alter transcriptional profiles, or affect semen or ultrasonographic characteristics, demonstrating that this method is viable for monitoring acute molecular changes in the testes.

31 Dec 2024·Plant Signaling & Behavior

Toxic and signaling effects of the anaesthetic lidocaine on rice cultured cells

Article

Author: Sylvain Bonfanti, Lucia ; Meimoun, Patrice ; Renault, Aurélien ; Arbelet-Bonnin, Delphine ; Filaine, Frédéric ; Grésillon, Etienne ; Bouteau, François ; Lalanne, Christophe ; Laurenti, Patrick

Most studies on anesthesia focus on the nervous system of mammals due to their interest in medicine. The fact that any life form can be anaesthetised is often overlooked although anesthesia targets ion channel activities that exist in all living beings. This study examines the impact of lidocaine on rice (Oryza sativa). It reveals that the cellular responses observed in rice are analogous to those documented in animals, encompassing direct effects, the inhibition of cellular responses, and the long-distance transmission of electrical signals. We show that in rice cells, lidocaine has a cytotoxic effect at a concentration of 1%, since it induces programmed reactive oxygen species (ROS) and caspase-like-dependent cell death, as already demonstrated in animal cells. Additionally, lidocaine causes changes in membrane ion conductance and induces a sharp reduction in electrical long-distance signaling following seedlings leaves burning. Finally, lidocaine was shown to inhibit osmotic stress-induced cell death and the regulation of Ca²⁺ homeostasis. Thus, lidocaine treatment in rice and tobacco (Nicotiana benthamiana) seedlings induces not only cellular but also systemic effects similar to those induced in mammals.

31 Dec 2024·Annals of medicine

Efficacy of intraoperative systemic lidocaine on quality of recovery after laparoscopic colorectal surgery: a randomized controlled trial

Article

Author: Lin, Wenjun ; Qiu, Chunlin ; Guo, Yanhua ; Zhuo, Yifen ; Yao, Yusheng ; Yang, Ying

INTRODUCTION:

Many clinical trials have demonstrated the benefits of intraoperative systemic lidocaine administration in major abdominal surgeries. We tested the hypothesis that systemic lidocaine is associated with an enhanced early quality of recovery in patients following laparoscopic colorectal resection.

PATIENTS AND METHODS:

We randomly allocated 126 patients scheduled for laparoscopic colorectal surgery in a 1:1 ratio to receive either lidocaine (1.5 mg kg^-1 bolus over 10 min, followed by continuous infusion at 2 mg kg^-1 h^-1 until the end of surgery) or identical volumes and rates of saline. The primary outcome was the Quality of Recovery-15 score assessed 24 h after surgery. Secondary outcomes were areas under the pain numeric rating scale curve over time, 48-h morphine consumption, and adverse events.

RESULTS:

Compared with saline, systemic lidocaine improved the Quality of Recovery-15 score 24 h postoperatively, with a median difference of 4 (95% confidence interval: 1-6; p = 0.015). Similarly, the area under the pain numeric rating scale curve over 48 h at rest and on movement was reduced in the lidocaine group (p = 0.004 and p < 0.001, respectively). However, these differences were not clinically meaningful. Lidocaine infusion reduced the intraoperative remifentanil requirements but not postoperative 48-h morphine consumption (p < 0.001 and p = 0.34, respectively). Additionally, patients receiving lidocaine had a quicker and earlier return of bowel function, as indicated by a shorter time to first flatus (log-rank p < 0.001), yet ambulation time was similar between groups (log-rank test, p = 0.11).

CONCLUSIONS:

In patients undergoing laparoscopic colorectal surgery, intraoperative systemic lidocaine resulted in statistically but not clinically significant improvements in quality of recovery (see Graphical Abstract).Trial registration: Chinese Clinical Trial Registry; ChiCTR1900027635.

232

News (Medical) associated with Lidocaine

30 Oct 2024

·www.globenewswire.com

Grace Therapeutics to Host Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage on November 20, 2024

PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced it will host a virtual key opinion leader (KOL) event on Wednesday, November 20, 2024 at 2:00 PM ET. To register, click here. The event will feature Abhishek Ray, MD (University Hospitals) and Andrew Webb, PharmD, BCCCP (Massachusetts General Hospital), who will discuss the high unmet medical need and current treatment landscape for patients suffering from aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency. A live question and answer session will follow the formal presentations. About Abhishek Ray, MD Abhishek Ray, MD, is a fellowship-trained, board-certified neurological surgeon at University Hospitals and Associate Professor of neurological surgery at Case Western Reserve University School of Medicine. He specializes in caring for people with cerebrovascular disease (brain aneurysms, stroke, AVMs), pituitary tumors and meningiomas, and in minimally invasive techniques to treat degenerative spine disease. In neurological surgery, there are often multiple ways to treat a single problem, and Dr. Ray is committed to providing each patient with an individualized care plan to optimize results. In 2021, 2022, 2023, and 2024, he was selected by his peers to be included in Cleveland Magazine’s list of Top Doctors. After completing his undergraduate degree in biological systems engineering at the University of California – Davis, Dr. Ray went back to his hometown to attend medical school at the University of Kansas School of Medicine in Kansas City, Kansas, where he was elected to be an ambassador of the school and was inducted into the Alpha Omega Alpha Honor Medical Society. He then went on to complete neurological surgery residency at University Hospitals/Case Western Reserve University School of Medicine, where he also completed fellowship training in neuro-interventional surgery. Dr. Ray stayed on as faculty at UH/Case Western Reserve University School of Medicine to advance neurosurgical education there. He created a unique and comprehensive neurological surgery elective for second-year medical students, of which he is now the course director. He has been an instructor at national skull base courses for neurosurgical residents and fellows and has served as editor of the neuro-interventional section of CNS Nexus, an online library of neurosurgical cases to better prepare trainees for the operating room. About Andrew Webb, PharmD, BCCCP Andrew Webb, PharmD, BCCCP, is a board-certified neurocritical care clinical pharmacy specialist at Massachusetts General Hospital (MGH) and serves as adjunct clinical faculty at Northeastern University School of Pharmacy and Pharmaceutical Sciences. His clinical and research interests include subarachnoid hemorrhage, status epilepticus, traumatic brain injury, and optimizing the medical management of neurocritically ill patients and his clinical practice is on the multidisciplinary neurocritical care team at MGH’s 22-bed neurosciences intensive care unit. Dr. Webb is originally from Rhode Island and completed his undergraduate studies and Doctor of Pharmacy at the University of Rhode Island. He then completed his pharmacy practice residency at Mayo Clinic in Rochester, MN followed by residency in critical care at Oregon Health & Science University in Portland, OR. Dr. Webb serves on the MGH Comprehensive Stroke Center Quality Taskforce and the MGH Neurology Quality Assurance and Committee on Patient Safety, focusing on improving the quality, safety, and effectiveness of medication therapy in stroke, subarachnoid hemorrhage, and other neurologic conditions. He is active in the Neurocritical Care Society, American College of Clinical Pharmacy, and Society for Critical Care Medicine and serves on several committees within these organizations related to critical care and neurology practice, research, and education. He has lectured regionally and nationally on the pharmacotherapy of subarachnoid hemorrhage, status epilepticus, and the unique challenges of pharmacotherapy in neurocritical care. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research. Outside of the United States, annual cases of aSAH are estimated at approximately 60,000 in the European Union, and approximately 150,000 in China. About the Grace Therapeutics Asset Portfolio GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTx-104 is estimated to be about $300 million, based on market research. GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTx-102 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-102 drug candidate. GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN). GTx-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTx-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTx-101 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-101 drug candidate. About Grace Therapeutics Grace Therapeutics is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutics’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’s lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.gracetx.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the timing of a data readout from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, the timing of the Company’s planned NDA submission with the FDA in connection with the Company's Phase 3 STRIVE-ON safety trial, GTx-104’s commercial prospects; the size of the addressable market for GTx-104, the Company’s beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company's other drug candidates are based upon Grace Therapeutics's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Grace Therapeutics's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Grace Therapeutics from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Grace Therapeutics Contact: Prashant KohliChief Executive OfficerTel: 609-322-1602Email: info@gracetx.com www.gracetx.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

Phase 1Orphan Drug

25 Oct 2024

·www.globenewswire.com

Acasti Announces Corporate Name Change to Grace Therapeutics, Inc.

Name Change Reflects Extensive Scientific and Corporate Brand Equity Previously Established under Grace Therapeutics Grace Therapeutics will begin trading on Nasdaq under the trading symbol "GRCE" effective October 28, 2024 Virtual Key Opinion Leader Event to be held on November 20th PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that it is changing its name to Grace Therapeutics, Inc. (Grace Therapeutics). Grace Therapeutics was the name of the company developing GTx-104 prior to its merger with Acasti in 2021. Grace Therapeutics will begin trading on Nasdaq under the trading symbol “GRCE” at the open of the market on October 28, 2024 and all company branding including corporate website will be updated accordingly. “The Grace Therapeutics brand reconnects us to our roots that are steeped in scientific innovation and highlights our transformative journey,” said Prashant Kohli, CEO of Acasti. “The breakthrough formulation of GTx-104 is the result of a decade of research by our exceptional scientific team while Grace Therapeutics was located in the pharma industry research corridor of New Jersey. We have continued to make significant progress in the clinical development plan of GTx-104, including full enrollment of the STRIVE-ON trial and anticipate a data readout in early calendar 2025 with an expected submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of calendar 2025. “In addition to advancing GTx-104 over the past 18 months, we successfully restructured to an agile biopharma model, rebuilt the management team, prioritized the pipeline, divested legacy assets, strengthened the balance sheet, and re-domiciled to the United States as a Delaware corporation. We believe these steps offer several potential benefits, including a U.S. corporate structure that should increase the company’s attractiveness and marketability to potential strategic partners and global institutional investors. We are proud of the progress made within a relatively short timeframe and look forward to fully realizing the Company’s value under the Grace Therapeutics brand.” The Company will host a Key Opinion Leader (KOL) event titled Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage, on November 20, 2024 at 2pm Eastern Time. To register for this debut event hosted by Grace Therapeutics, click here. A replay of the event will be available and archived for at least 180 days after the webcast. About the Acasti Asset Portfolio GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTx-104 is estimated to be about $300 million, based on market research. GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTx-102 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-102 drug candidate. GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN). GTx-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTx-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTx-101 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-101 drug candidate. About Acasti Acasti is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Acasti’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Acasti’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti’s lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.acasti.com or www.gracetx.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the timing of a data readout from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, the timing of the Company’s planned NDA submission with the FDA in connection with the Company's Phase 3 STRIVE-ON safety trial, GTx-104’s commercial prospects; the size of the addressable market for GTx-104, the Company’s beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company's other drug candidates are based upon Acasti's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Acasti from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Acasti Contact: Prashant KohliChief Executive OfficerTel: 450-686-4555Email: info@acastipharma.com www.acasti.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

Phase 1Orphan DrugAcquisitionNDA

07 Oct 2024

·www.prnewswire.com

Oramed Pharmaceuticals Announces Restructuring of Scilex Holding Company Debt

NEW YORK, Oct. 7, 2024 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ("Oramed"), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced the execution of definitive agreements for the restructuring of a portion of its existing Senior Secured Promissory Note from Scilex Holding Company (Nasdaq: SCLX) ("Scilex"), a company focused on non-opioid pain management products. Key Highlights: Oramed, affiliates of Murchinson and 3i LP, entered into definitive agreements with Scilex for the purchase and sale of new tranche B senior secured convertible notes ("Notes") in the aggregate principal amount of $50 million (the "New Financing") and warrants to purchase up to 7,500,000 shares of the Company's common stock in the aggregate in a registered direct offering. Oramed has agreed to restructure $22.5 million of the outstanding principal balance under Scilex's existing Senior Secured Promissory Note, originally due to Oramed between September 2024 and March 2025. In exchange, Oramed will receive: A Note having an aggregate principal amount of $25 million at issuance, with an original issue discount of 10.0%, that bears interest at a rate of 5.5% per annum, is convertible into shares of Scilex common stock at the option of holder at a conversion price equal to $1.09 (subject to certain adjustments) and matures on the two -year anniversary of issuance; Warrants to purchase up to 3.75 million shares of Scilex common stock with an exercise price of $1.09 (subject to certain adjustments) that are immediately exercisable and expire five years from issuance; and the application by Silex at closing of $12.5 million of the proceeds from the New Financing from the non-Oramed purchasers towards the repayment of such amount of outstanding principal under the Oramed Senior Secured Promissory Note. In order to facilitate the ongoing negotiation of the New Financing, Oramed agreed to further extend certain payments due from Scilex under the Senior Secured Promissory Note on September 23, 2024 to October 7, 2024. The closing of the New Financing is expected to occur on or about October 7, 2024, subject to satisfaction of certain closing conditions. After giving effect to these transactions, an aggregate of $54.2 million of the original principal amount under the Senior Secured Promissory Note has been repaid or refinanced. Separately, Oramed and certain other institutional investors anticipate acquiring the right to receive an 8% royalty on the net sales of certain of Scilex's products, including ZTlido (lidocaine topical system). Oramed is entitled to receive 50% of such proceeds from the net sales of the products. Oramed's purchase consideration in such transaction is intended to be satisfied through a reduction of $2.5 million of the outstanding principal balance on the Senior Secured Promissory Note. The closing of the royalty transaction is anticipated to occur contemporaneous with the closing of the New Financing. "We believe that this restructuring significantly enhances the potential value of our investment in Scilex," said Nadav Kidron, CEO of Oramed Pharmaceuticals. "While slightly extending the payment schedule of a portion of our investment, it offers us substantial potential upside, including through warrants and conversion options. We are also excited to have a stake in the growth and prospects of ZTlido. This aligns perfectly with our strategy of maximizing value for our shareholders while supporting innovative healthcare solutions." About Oramed Pharmaceuticals Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The Company's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit . Forward-looking statements: This press release contains forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions and include statements about the completion of the New Financing and royalty transaction, the satisfaction of customary closing conditions related to the New Financing, the benefits and value of the New Financing, the royalty transaction and related transactions with Scilex, the value of Scilex's securities, its growth trajectory, commercial portfolio and infrastructure and clinical stage pipeline. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in the Company's other filings with the Securities and Exchange Commission, which factors are incorporated herein by reference and the following factors: risks that the New Financing and royalty transaction do not close; the risk that Scilex may be unable to service the debt provided by the Note and the existing Senior Secured Promissory Note and the impact of the New Financing's obligations on Scilex's liquidity; risks associated with the Company's ability to recover the proceeds and/or collateral under the Note, the existing Senior Secured Promissory Note and related agreements; the possibility that the anticipated benefits of the transactions with Scilex are not realized when expected or at all, including as a result of the impact of, or problems arising from, the ability of Scilex to repay the indebtedness and the ability of the Company to realize the value of the warrants and Notes; risks associated with the fluctuating market price and liquidity of the Scilex common stock underlying the warrants and Notes; and risks associated with the unpredictability of trading markets, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. These forward-looking statements speak only as of the date hereof. Oramed undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect actual outcomes, unless required by law. Company Contact: +1-844-9-ORAMED [email protected] Logo: SOURCE Oramed Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Lidocaine

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KEGG	Wiki	ATC	Drug Bank
D00358	Lidocaine	D04AB01 S02DA01 C01BB01	DB00281

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain	JP	Nitto Denko Corporation	05 Oct 1994
Ventricular Arrhythmia	JP	Sandoz AG	01 Sep 1976
Hyperemesis Gravidarum	CN	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1976
Neuralgia, Postherpetic	US	AstraZeneca LP	17 May 1951
Anesthesia	-	-	01 Jan 1947
Tachycardia, Ventricular	-	-	01 Jan 1947

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic peripheral neuropathic pain	Phase 3	CN	Beijing Tide Pharmaceutical Co., Ltd.	07 Jan 2022
Chronic Pain	Phase 3	AT	Grünenthal GmbH	01 Oct 2012
Chronic Pain	Phase 3	BE	Grünenthal GmbH	01 Oct 2012
Chronic Pain	Phase 3	BR	Grünenthal GmbH	01 Oct 2012
Chronic Pain	Phase 3	DK	Grünenthal GmbH	01 Oct 2012
Chronic Pain	Phase 3	FR	Grünenthal GmbH	01 Oct 2012
Chronic Pain	Phase 3	IT	Grünenthal GmbH	01 Oct 2012
Chronic Pain	Phase 3	ES	Grünenthal GmbH	01 Oct 2012
Chronic Pain	Phase 3	GB	Grünenthal GmbH	01 Oct 2012
Neuralgia	Phase 3	AT	Grünenthal GmbH	01 Oct 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04356352 (CTgov)	Phase 2/3	Pain \| Injection Site Reaction	33	Lidocaine (Lidocaine)	dccqhyvsyn(fkvbyxjtex) = nlwzwxsxmi jfkxunrnfi (rmoouodmqq, smxmsunkzw - slcyeneywx) View more	-	19 Sep 2024
				Esmolol (Esmolol)	dccqhyvsyn(fkvbyxjtex) = sonuxjkfxt jfkxunrnfi (rmoouodmqq, kszxhkhadc - yhffuhxfsz) View more
NCT04995497 (CTgov)	Phase 2	Pain, Postoperative	70	Administration of Lidocaine Post Cardiac Surgery via ESP Catheter (Erector Spinae Plane Block-Administration of Lidocaine)	wpfpjdgfez(sxncwurikv) = gbxrtvzyvq brjcbhncpb (jmcbykfhuc, xevjhjxptt - umlzxwcbkk) View more	-	04 Sep 2024
				Intravenous Administration of Lidocaine Post Cardiac Surgery (Intravenous-Administration of Lidocaine)	wpfpjdgfez(sxncwurikv) = sidvkxeqbx brjcbhncpb (jmcbykfhuc, pihmxsxjhq - aeshimbfug) View more
NCT05711641 (CTgov)	Not Applicable	Tinnitus	32	Lidocaine 10 MG/ML (Lidocaine 10%)	bnmlauzwtv(wkpwvuqwxr) = wrxmzvuhib ohpdfqsgle (plqcjpedmi, qvdkkzdimd - jchelrlwnz) View more	-	30 Aug 2024
				Distilled water (Placebo)	bnmlauzwtv(wkpwvuqwxr) = gmmiuqwbpn ohpdfqsgle (plqcjpedmi, sqtbauoszr - wggzfexcgi) View more
NCT02229578 (LidocaineBurn, CTgov)	Phase 4	Burns \| Pain, Postoperative	34	Lidocaine (Lidocaine Treatment Group)	gadlpsbnbk(enbtlxsbni) = lxutvikcuh rsrrbycokl (aswrblrfjg, edmeiyuisl - dboqfseklu) View more	-	01 Jul 2024
				Placebo (Placebo Treatment Group)	gadlpsbnbk(enbtlxsbni) = ffpdnsgmyb rsrrbycokl (aswrblrfjg, axcbpyvlje - tysebekbgf) View more
RepurpSS-I (EULAR2024)	Not Applicable	Sjogren's Syndrome	29	Lidocaine (Non-palsy affected eyes)	qhwqwmziqm(qhujgyxdcv) = Lidocaine-induced facial palsy occurred upon parotid biopsy on 14 occasions, in two of 12 patients palsy occurred at baseline and at week 24 ykvcxsxuwt (pykpfftlgi )	Positive	05 Jun 2024
NCT04648891 (CTgov)	Phase 2/3	Spastic Dysphonia	32	Botox (Control)	wuenvgqtjy(tixghjxugj) = zbwbenzqfp vdlilrcfvj (gaauelhdyi, ussegubtsx - vztowgpysr) View more	-	23 May 2024
				Lidocaine (Lidocaine)	wuenvgqtjy(tixghjxugj) = jsbvkzdklw vdlilrcfvj (gaauelhdyi, mvwjiywtci - ofkymriepq) View more
NCT05227300 (CTgov)	Phase 4	Pulpitis	40	1:100,000 epinephrine+Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution+2% lidocaine (Buffered 2% Lidocaine With 1:100,000 Epinephrine)	vugenetknf(hejirxcdop) = vgefsjhymr wfbpnaqybq (soylwkrsgu, uivhietibi - frvfksjvjk) View more	-	14 May 2024
				1:100,000 epinephrine+2% lidocaine (Unbuffered 2% Lidocaine With 1:100,000 Epinephrine)	vugenetknf(hejirxcdop) = fnzxgtaxhl wfbpnaqybq (soylwkrsgu, lvryormuyi - jxgcvwbshh) View more
NCT03526874 (CTgov)	Phase 3	Acute migraine	63	Lidocaine Hydrochloride 2 mg/mL Injectable Solution+Lidocaine 4% Topical Application Cream [LMX 4] (Greater Occipital Nerve (GON) Block With Lidocaine)	kwrlvtjivs(gwmggaxivm) = wbobbxzxyi rqbyuznqrc (inzwtlvwaj, jhttqrdwzz - tvcjzjvcce) View more	-	30 Apr 2024
				Lidocaine 4% Topical Application Cream [LMX 4]+Normal Saline (Greater Occipital Nerve (GON) Block With Saline)	kwrlvtjivs(gwmggaxivm) = plgvffcifb rqbyuznqrc (inzwtlvwaj, lxupubvarr - nstxfdahwy) View more

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