Last update 16 May 2024

Lidocaine

Last update 16 May 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

LQS, Lidocaine Carbonate, Lidocaine Hydrochloride

+ [33]

Target

SCNA

Mechanism

SCNA blockers(Sodium channel alpha subunit blockers)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesUrogenital Diseases+ [6]

Active Indication

Neuralgia, PostherpeticPainVentricular Arrhythmia+ [12]

Inactive Indication

Cough

Originator Organization-

Active Organization

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

+ [12]

Inactive Organization

AstraZeneca LP

GSK Plc

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1947),

AnesthesiaTachycardia, Ventricular

RegulationFast Track (US), Priority Review (CN)

Structure

Molecular FormulaC14H22N2O

InChIKeyNNJVILVZKWQKPM-UHFFFAOYSA-N

CAS Registry137-58-6

2,103

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

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

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

NCT05461053 / WithdrawnPhase 4IIT

A Randomized Controlled Trial for Conservative Management of Cutaneous Abscess Using Topical Anesthetic in Children as Compared to Standard Management

This is a single center non-blinded randomized trial of topical anesthetic cream to usual care (warm compresses and time) for superficial, non-perianal abscesses in children under 18 years of age. The primary outcome is time to spontaneous drainage. The secondary outcomes are return to emergency room/hospital/care provider and need for incision and drainage. Information on patient experience using standardized patient reported outcome measures for health-related quality of life will also be gathered. The findings of this study will provide more robust evidence of the benefit of this treatment including a potential reduction in cost and allow for more widespread dissemination.

Start Date01 Jan 2025

Sponsor / Collaborator

Rush University Medical Center

100 Clinical Results associated with Lidocaine

100 Translational Medicine associated with Lidocaine

100 Patents (Medical) associated with Lidocaine

28,646

Literatures (Medical) associated with Lidocaine

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

INTRODUCTIONMany 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 METHODSWe 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.RESULTSCompared 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).CONCLUSIONSIn 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.

01 Oct 2024·Journal of Stomatology, Oral and Maxillofacial Surgery

Comparison of postoperative analgesia in children following ropivacaine and lidocaine surgical field infiltration with epinephrine for cleft palate repair: A double-blinded, randomized controlled trial

Article

Author: Jin, Shangyi ; Yu, Gaofeng ; Jin, Saifen ; Xie, Haihang ; Chen, Jinghui ; Chen, Yiyang ; Song, Xingrong

STUDY OBJECTIVEThe study aimed to evaluate the efficacy of ropivacaine in providing postoperative analgesia for children undergoing cleft palate repair.METHODSA double-blinded, randomized controlled trial was conducted on sixty-four children scheduled for cleft palate repair. The patients received either local infiltration with 1% lidocaine or 0.2% ropivacaine before incision. The primary outcome was the postoperative average pain score, and secondary outcomes included pain scores at various time points, consumption of flurbiprofen and hydromorphone, effectiveness of nurse-controlled analgesia pump, and incidence of bradycardia, vomiting, and respiratory depression.MAIN RESULTSThe results showed that the postoperative average pain score was significantly lower in the ropivacaine group compared to the lidocaine group (1.27±0.28 vs. 1.75±0.29, P<0.001). Pain scores at multiple postoperative time points were also lower in the ropivac:aine group. Additionally, consumption of flurbiprofen and hydromorphone was lower, and ineffective compressions of the nurse-controlled analgesia pump were reduced in the ropivacaine group. The incidence of vomiting, bradycardia, and respiratory depression did not show significant differences between the two groups.CONCLUSIONLocal infiltration with ropivacaine effectively provided postoperative analgesia for children undergoing cleft palate repair without major side effects. It was found to be superior to lidocaine in reducing the need for additional rescue analgesia.

01 Jun 2024·Osteoarthritis and Cartilage Open

The effects of exercise and intra-articular injections versus exercise alone for the treatment of knee osteoarthritis: A scoping review of the evidence

Review

Author: White, Daniel K ; Bley, Bradley ; Liles, Sydney C

ObjectiveCurrent treatment for knee Osteoarthritis (OA) includes exercise and intra-articular injections with corticosteroid (CS), hyaluronic acid (HA), etc., which address OA-related pain and functional limitation. While these interventions can be given together, little is known about the efficacy of a multi-modal approach. The purpose of this scoping review is to examine studies that compare combining exercise and intra-articular knee injections to exercise alone for the management of knee OA.MethodsA search was performed using PubMed, CINAHL, and Clinicaltrials.gov with MeSH terms "knee osteoarthritis" AND "exercise" AND "injections". Abstracts were screened to meet inclusion criteria of both intervention groups including exercise and one group receiving an injection for treatment of knee OA. Full text articles were screened to meet inclusion criteria and rated using the Pedro Scale.Results11 studies that met inclusion criteria. The included studies utilized CS, hyaluronic acid (HA), and Bone Marrow Concentrate (BMC), botulinum toxin A, or a combination of dextrose and lidocaine injections. Most studies included supervised exercise interventions with all studies including strengthening of the quadriceps. CS and exercise compared to exercise alone showed similar improvements in pain. The HA injection studies yielded mixed results with two studies finding HA and exercise was not superior than exercise alone while two other studies found that HA and exercise were superior.ConclusionThere was a paucity of literature investigating multimodal approaches. Most of the included studies did not find superior effects of adding a knee injection to exercise compared to exercise alone for knee OA.

197

News (Medical) associated with Lidocaine

13 May 2024

·www.globenewswire.com

Scilex Holding Company Provides Information to Scilex Stockholders Regarding Manipulative and Naked Short Selling of Scilex Common Stock

Scilex management is determined to enhance its stockholders’ value and protect their stockholder rights, and is taking steps to combat manipulative and naked short selling practices in Scilex common stock.Of the approximately 181 million shares of Scilex common stock currently issued and outstanding: (a) 76 million were distributed by Sorrento Therapeutics, Inc. (OTC: SRNEQ, “Sorrento”) as dividend shares in January 2023 (the “Dividend Shares”) and are restricted from trading until the earlier of (i) September 30, 2024 per court order or (ii) the date on which Sorrento and its Official Committee of Unsecured Creditors agree in writing or on the record in Sorrento’s chapter 11 cases certain claims that may be asserted in potential litigation to avoid Sorrento’s distribution of Dividend Shares and to recover such Dividend Shares; (b) another approximately 60 million shares of Scilex common stock, along with approximately 29 million of shares of Scilex preferred stock, were repurchased by Scilex in September 2023; and (c) approximately 45 million shares of Scilex common stock constitute the unrestricted public float trading on the Nasdaq Capital Market.According to credible information available to Scilex, Scilex management believes there are approximately 10 million shares of Scilex common stock being sold short and additionally, there are more than 10 million Dividend Shares deemed to have been sold as “naked short” positions on or after January 2023 that have not been covered as of today. The Company believes that there are substantial “naked short” positions in approximately 44 million shares of its common stock that had not cast votes based on the reports tabulated by Broadridge Financial Solutions, Inc., an independent third party that collects and tabulates stockholder votes, for the Company’s prior two annual meetings for its stockholders. This represents a failure by the brokerage firms to deliver the Dividend Shares to the beneficial owner accounts for approximately 15 months constituting a potential violation of Regulation SHO.Sample letter for Scilex stockholders to send to their brokerage firms to recall loaned shares of Scilex common stock from Brokerages’ Lending Programs. Sample letter for the beneficial owners, eligible to receive dividend shares of the Company (the “Dividend Shares”) previously distributed by Sorrento Therapeutics, Inc. (OTC: SRNEQ, “Sorrento”) to its stockholders as a dividend, to demand immediate delivery of the Dividend Shares from such Brokerage Firms as Record Holders. PALO ALTO, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today provides information to its stockholders regarding short selling of Scilex common stocks traded on the Nasdaq Capital Market. According to credible information available to Scilex, Scilex management believes there are approximately 10 million share of Scilex common stock being sold short and additionally, there are more than 10 million Dividend Shares deemed to have been sold as “naked short” positions on or after January 2023 that have not been covered as of today. The Company believes that there are substantial “naked short” positions in approximately 44 million shares of its common stock that had not cast votes based on the reports tabulated by Broadridge Financial Solutions, Inc., an independent third party that collects and tabulates stockholder votes, for the Company’s prior two annual meetings for its stockholders. This represents a failure by the brokerage firms to deliver the Dividend Shares for approximately 15 months constituting a potential violation of Regulation SHO. The practice of manipulative or abusive “naked short” selling or maintaining “naked short” positions may constitute a violation of SEC Regulation SHO. Scilex Management is determined to combat manipulative and illegal short selling of Scilex common stock which has the effect of reducing shareholder value and infringing on shareholders’ rights. In addition to communicating with regulatory authorities and through the legal processes demanding accurate information pertaining to Scilex stock trades to expose any manipulative and illegal “naked short selling” of Scilex stock, Scilex Management is providing Scilex stockholders with the following information to help combat manipulative short selling or illegal naked short selling or naked short positions in its shares: Scilex stockholders holding shares on loan in their margin accounts can choose to do the following: recall their shares from their brokerage firms that administer such lending programs by opting out of any share lending programs;demand that their shares to be held in a cash account; and/ormove their shares to a Direct Registration (“DRS”) account at the Company’s transfer agent, Continental Stock Transfer & Trust Company. Sample Letter to Brokerage to Recall Loaned Shares. If a stockholder decides to instruct its brokerage firm not to make their shares of Scilex common stock available for lending, the following is a sample of language that can be used in their communication to the brokerage firm: Broker name;Broker address;Attn: Agent for Your Account;Brokerage account number;The letter should state clearly that the shares of Scilex common stock are to be held in a cash account and should be not made available for any lending programs in the brokerage firm and to not loan any such shares. Additionally, as applicable, there should be a request to recall any such shares that are currently on loan; andDemand that the brokerage firm confirm the receipt and compliance with such request. Beneficial owners of Dividend Shares, previously distributed by Sorrento to its stockholders as a dividend, can choose to demand their brokerage firms immediately deliver the Dividend Shares to the stockholders’ individual cash brokerage account or to the Company’s transfer agent. A list of the Brokerages that are Record Holders can be found on this link from previously published FAQ. Sample Letter to Brokerage to Demand Delivery of the Dividend Shares. If a stockholder decides to instruct its brokerage firm, as the Record Holder of such stockholder’s Dividend Shares, to immediately deliver the Dividend Shares to the stockholders’ individual cash brokerage account or to the Company’s transfer agent the following is a sample of language that can be used in their communication to the brokerage firm: Broker name;Broker address;Attn: Agent for your Account;Brokerage account number;The letter should state clearly that you are a beneficial owner of Dividend Shares and you demand immediate delivery of such shares to your individual cash brokerage account or to the Company’s transfer agent from your brokerage firm acting as a Record Holder of these Dividend Shares;Include the number of Dividend Shares that you were entitled to receive from Sorrento as Dividend Shares by stating how many Sorrento shares you held on January 9, 2023, the record date for receiving Dividend Shares; andDemand that the brokerage firm confirm the receipt and compliance with your request. Please note it is not uncommon to provide this written communication to brokerage firm to not lend their clients’ shares for the purpose of short selling. Similar guidance was recently sent out by Trump Media & Technology Group Corp. (Nasdaq: DJT) to its shareholders highlighting actions that its shareholders can take to prevent the lending of their shares by brokerage firms for the purpose of short selling. Not Investment Advice The information in this release does not constitute or purport to be investment advice. The Company encourages stockholders to speak with their financial advisors about any transactions and strategies such as using cash accounts to hold their securities instead of margin accounts and the lack of liquidity resulting from or costs of transferring and holding their shares at the Company’s transfer agent to ensure they are appropriate for the stockholders’ individual circumstances. Additional Information Regarding Moving Shares Out of Brokerage Accounts Please note that stockholders may incur certain costs in connection with transferring shares out of a brokerage account and, once their shares are moved to our transfer agent, their ability to timely transfer their shares back to a brokerage firm and sell may be a longer process. Holding shares in physical certificate form involves risk of loss or destruction where a bond of indemnity is required to replace the certificate(s). For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, expected to launch in the first half of 2024. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and has granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s beliefs of the scale of short selling, lending program activities and market manipulation of its stock price, any potential violations of law and legal challenges with respect to the actions believed to be taken by brokerage firms that are described in this press release, Scilex’s expectation to launch Gloperba® in the first half of 2024. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved. PDFs accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3761da25-5a66-4268-8f2c-ef3896d41b8f https://www.globenewswire.com/NewsRoom/AttachmentNg/bacc858d-8915-4f98-b7b5-7ee7428c20ae https://www.globenewswire.com/NewsRoom/AttachmentNg/919cd2fb-538a-4c8c-bbb3-b614484a0c3a

Fast TrackPhase 3Phase 2Drug Approval

09 May 2024

·www.globenewswire.com

AEON Biopharma Provides Update on Development Pipeline

Includes two late-stage clinical programs and two early-stage clinical programsIRVINE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, today provided an update on the status of its late-stage clinical pipeline for ABP-450 that targets multiple indications. “In addition to our early-stage clinical programs, we have multiple late-stage programs designed to show the safety and efficacy of ABP-450 in the treatment of various indications. Several of these programs are ready to advance into the next stage of clinical development. When taking into consideration our clinical pipeline and combining it with our differentiated business model, we see a number of compelling opportunities to pursue,” said Marc Forth, President and Chief Executive Officer of AEON. “While we were disappointed that ABP-450 did not demonstrate statistically significant superiority over placebo in its interim Phase 2 readout for chronic migraine, this does not diminish our enthusiasm for our migraine program, which includes our issued patent (U.S. Patent No. 11,826,405) for our novel migraine injection paradigm, nor the other indications that have well-founded scientific rationale to pursue in clinical trials.” Portfolio Overview: Migraine. Episodic Migraine - Completed Phase 2 study of ABP-450 for the preventive treatment of episodic migraine. The Company recently held a productive end-of-Phase 2 (EOP2) meeting with the U.S. FDA to present the Company’s Phase 2 episodic migraine study results, which demonstrated a favorable safety profile for patients with episodic migraine and achieved key prespecified secondary endpoints, although it did not statistically separate from placebo with respect to the primary endpoint. The EOP2 meeting resulted in preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trial.Chronic Migraine - Ongoing analysis of interim data from the Phase 2 study of ABP-450 in chronic migraine, which did not achieve its primary or secondary endpoints. Cervical Dystonia - Ready to initiate a Phase 3 study of ABP-450 in cervical dystonia (CD), pending finalization of the trial protocol. The Phase 2 study of ABP-450 in adults with CD met primary and secondary endpoints with statistical significance in reducing signs and symptoms associated with CD. The Company presented the Phase 2 CD clinical data at TOXINS 2024 Conference (click here). Gastroparesis - Ready for a Phase 2 study of ABP-450 in gastroparesis; IND already cleared by the FDA.Post-Traumatic Stress Disorder (PTSD) - IND-enabling studies are already planned, which are designed to support the development of ABP-450 in PTSD. The Company recently presented pilot data at the TOXINS 2024 Conference (click here) that confirm the accurate delivery of combination doses of lidocaine and ABP-450, with evidence of appropriate Stellate Ganglion Block (SGB) targeting without significant signs of toxicity. The Company believes these pilot data support future studies of ABP-450 as a potential treatment of PTSD. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, or the FDA, Health Canada and European Medicines Agency, or EMA. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com. Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding AEON’s expected capital resources and liquidity needs and the anticipated timing of AEON’s clinical results are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements, including with respect to potential obligations pursuant to the forward purchase agreement termination letters; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements. Source: AEON Biopharma

Phase 2Clinical Result

09 May 2024

·www.biospace.com

Pulse Biosciences Announces First U.S. Procedure with the CellFX nsPFA Percutaneous Electrode System

HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX® Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced the first procedure with the CellFX nsPFA Percutaneous Electrode System in the United States has been completed. The successful case is the first in the Company’s pilot program which follows the March 2024 U.S. FDA 510(k) clearance for the ablation of soft tissue in percutaneous and intraoperative surgical procedures with the system. “I am very proud and excited that the first U.S. patient treatment with soft tissue ablation by the CellFX nsPFA system was performed this week in our Thyroid and Parathyroid Center here at Sarasota Memorial Hospital,” said Dr. Ralph P. Tufano, Medical Director, Head and Neck Endocrine Surgery for the Sarasota Memorial Health Care System in Sarasota, Florida. “The cell-specific mechanism of action of nsPFA allowed me to treat this patient with confidence, knowing that I was not going to cause collateral damage to acellular structures. The patient was treated for a large, symptomatic, benign, thyroid nodule in our office with just local lidocaine and tolerated the procedure extremely well, reporting no pain during nsPFA energy delivery, and is doing great. Based on the impressive results we have seen come out of Italy, I am confident the outcome of the procedure will be excellent. I am looking forward to continuing my collaboration with Pulse Biosciences to further refine the procedure and offer this life-changing new technology to my patients and to help to train other experts in this exciting new procedure.” The CellFX nsPFA Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary CellFX nsPFA Console. Our proprietary and novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. This proprietary system is designed for non-cardiac applications. “Treating our first patient under our newly FDA-cleared nsPFA percutaneous system is a fundamental and opportune milestone for Pulse Biosciences,” said Mitch Levinson, Chief Strategy Officer of Pulse Biosciences. “It is inspiring to see the difference our physicians can make in their patients’ lives with our unique proprietary technology, giving them the potential to set new standards for safety and efficacy as well as decreased workflow time from patient set-up to procedure finish. The administration of local anesthesia at the treatment site with the patient awake, without the need for general anesthesia, in cases to date, is a noteworthy positive. Team Pulse Biosciences is deeply grateful to Dr. Tufano for his partnership over the past 3 years. We are all looking forward to evolving the standard of medicine as together we optimize and introduce the CellFX nsPFA percutaneous procedure on a controlled and measured basis through the balance of 2024.” Thyroid nodule soft tissue ablation procedures were performed on 30 patients with the CellFX nsPFA Percutaneous System in Italy from April 2023 through January 2024. Per amended study protocols, patients were observed and evaluated in follow-up visits to assess the procedure as early as one week post procedure, and up to this point, as late as 180 days post procedure. Patient follow-ups were conducted weekly for the first 4 weeks, then at 30-, 90-, 180-, and 360-day timepoints following the procedures. No evidence of scarring or injury to surrounding tissue has been observed, and patient treatments have been judged to be successful. About Pulse Biosciences® Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries. Forward-Looking Statements All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the effectiveness of the Company’s CellFX nsPFA technology and CellFX System to non-thermally clear cells while sparing adjacent non-cellular tissue, statements concerning the Company’s expected product development efforts and plans to sell products commercially, such as its plans to demonstrate advantages of its CellFX nsPFA Percutaneous Electrode over current treatment options, statements concerning the timing and nature of the Company’s pilot program to optimize and introduce the CellFX nsPFA percutaneous procedure on a controlled and measured basis, statements concerning customer adoption and future use of the CellFX System to address a range of conditions, such as benign thyroid nodules, and whether any future procedures using the CellFX System may or may not require general anesthesia, statements concerning early clinical successes and whether they are predictive of the safety and efficacy of any medical device such as the CellFX nsPFA Percutaneous Electrode System, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

100 Deals associated with Lidocaine

External Link

KEGG	Wiki	ATC	Drug Bank
D00358	Lidocaine	D04AB01 S02DA01 C01BB01 R02AD02 N01BB02 C05AD01 S01HA07	DB00281

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuralgia, Postherpetic	US	Teikoku Pharma USA, Inc.	19 Mar 1999
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
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
Pain	Phase 3	CN	China Center for Pharmaceutical International Exchange (CCPIE)	03 Apr 2015
Postoperative ileus	Phase 2	DE	Orexa BVStartup	11 Jan 2024
Acute low back pain	Phase 2	US	SCILEX Pharmaceuticals, Inc.	29 Apr 2022
Cough	Phase 2	GB	GSK Plc	17 Oct 2011
Neck Pain	Phase 2	-	SCILEX Pharmaceuticals, Inc.	-
Herpes Zoster	Phase 1	CN	Teikoku Seiyaku Co. Ltd.	29 Jul 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00140088 (COMFORT-004, Pubmed \| Med Lett Drugs Ther) Manual	Phase 3	Pain, Procedural	535	Lidocaine	(xaiibfchco) = The active system group had significantly less pain compared with the sham placebo in all age groups combined according to the modified Wong-Baker FACES scale. ggrbxuynjm (sjjdxwuwlv ) View more	Positive	01 Aug 2015
				Placebo
NCT05096494 (GlobeNewswire) Manual	Phase 2	Acute low back pain	75	SP-103	(mnqrdzbekd) = aiiriadvih orxlwmdfyn (hqewpvocaj )	Positive	14 Sep 2023
				Placebo	(mnqrdzbekd) = cpaddjbkgh orxlwmdfyn (hqewpvocaj )
ChiCTR2000038653 (Pubmed)	Not Applicable	-	-	Saline solution	(bjxingcorw) = zutxjhfrlr lgvkojvzky (nemlqntgwc )	-	22 Jun 2022
				2% lidocaine	(bjxingcorw) = kteuqjcqrk lgvkojvzky (nemlqntgwc )
Pubmed	Not Applicable	Heart Diseases	-	Opioid-balanced general anesthesia with lidocaine	cmakqlltrj(vjpacgxhqk): OR = 0.72 (95% CI, 0.58 - 0.92)	Positive	10 Feb 2023
				Nonopioid-balanced general anesthesia
TCTR20200909006 (Pubmed) Manual	Phase 3	De Quervain Disease	60	Lidocaine+Adrenaline+Ketorolac	osgtpcjfoh(vfncmvaibb) = darrdggpxn zsdpsysfzo (ldmttsqgcz, 2.0)	Negative	01 Sep 2022
				Lidocaine+Adrenaline+Triamcinolone Acetonide	osgtpcjfoh(vfncmvaibb) = qvqifjtlpr zsdpsysfzo (ldmttsqgcz, 3.2)
GlobeNewswire Manual	Not Applicable	Neck Pain	76	ZTlido	(furahikhcx) = ikdsbweuxi bfdsgcpsxe (oiiktcjtzl ) Met	Positive	20 Feb 2024
				Placebo	(furahikhcx) = dbqxtwreqw bfdsgcpsxe (oiiktcjtzl ) Met
CTRI/2014/11/005228 (ESMO2022)	Phase 3	Early Stage Breast Carcinoma	1,600	Peri-tumoral injection of lidocaine	(pghpqieyzf) = cimjinpdjf yrnpafsbql (nkriakjudy ) View more	Positive	12 Sep 2022
				local anaesthetic (Surgery without lidocaine)	(pghpqieyzf) = pckfglwras yrnpafsbql (nkriakjudy ) View more
NCT04773093 (Pubmed)	Phase 1/2	-	60	Lidocaine	yjgpujsxvb(hwfrjssndb) = khbirgrrek qgdmcxhbcl (qsnbtezeao ) View more	Positive	09 Sep 2022
				Placebo (NaCl 0.9%)	yjgpujsxvb(hwfrjssndb) = tycuyfwymu qgdmcxhbcl (qsnbtezeao ) View more
NCT03636451 (Pubmed)	Phase 3	-	114	20-mL buffered 1% lidocaine paracervical block	(rgsmzlduqs) = drkwmincud nlyktxadme (tjlcegojps ) View more	Negative	01 Aug 2022
				40-mL buffered 0.5% lidocaine paracervical block	(rgsmzlduqs) = ihgiflctrg nlyktxadme (tjlcegojps ) View more
ChiCTR2200059450 (Pubmed)	Phase 1	Hodgkin's Lymphoma	59	Propofol + Normal Saline	nvckkmykvp(hqyvehpeql) = wvlkzhldux ixnhmenjkf (ryxxekajev )	-	17 Oct 2022
				Propofol + Lidocaine	nvckkmykvp(hqyvehpeql) = cccnhymvpb ixnhmenjkf (ryxxekajev )

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