A Phase 2/3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TLC590 for Postsurgical Pain Management Following Inguinal Hernia Repair

A phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery.

Start Date01 Apr 2025

Sponsor / Collaborator

Taiwan Liposome Co., Ltd.

CTRI/2024/03/064555 / Not yet recruitingPhase 3IIT

A comparative study of effect of intrathecal hyperbaric Ropivacaine 0.75% vs hyperbaric Bupivacaine 0.5% for postoperative analgesia in Infraumblical surgeries - nil

Start Date07 Mar 2025

Sponsor / Collaborator

Jawaharlal Nehru Medical College & Hospital

CTRI/2024/11/076745 / Not yet recruitingPhase 2/3IIT

Comparison of Nebulised Ropivacaine 0.75 percent Versus Nebulised Dexmedetomidine and Nebulised lignocaine 4 percentin patients undergoing surgery under General Anesthesia. - Nil

Start Date23 Feb 2025

Sponsor / Collaborator-

100 Clinical Results associated with Ropivacaine Hydrochloride

100 Translational Medicine associated with Ropivacaine Hydrochloride

100 Patents (Medical) associated with Ropivacaine Hydrochloride

6,167

Literatures (Medical) associated with Ropivacaine Hydrochloride

01 Jan 2025·ANAESTHESIA

Combined spinal‐epidural vs. dural puncture epidural techniques for labour analgesia: a randomised controlled trial*

Article

Author: Habib, Ashraf S. ; Padilla, Andrew ; Fuller, Matthew ; Rubright, Samantha M. ; Pham, Trung ; Craig, Amanda ; Zang, Hannah

Summary:

Background:

The dural puncture epidural technique is a modification of the combined spinal‐epidural technique. Data comparing the two techniques are limited. We performed this randomised study to compare the quality of labour analgesia following initiation of analgesia with the dural puncture epidural vs. the combined spinal‐epidural technique.

Methods:

Term parturients requesting labour epidural analgesia were allocated randomly to receive either dural puncture epidural or combined spinal‐epidural. Analgesia was initiated with 2 mg intrathecal bupivacaine and 10 μg fentanyl in parturients allocated to the combined spinal‐epidural group and with 20 ml ropivacaine 0.1% with 2 μg.ml‐1 fentanyl in parturients allocated to the dural puncture epidural group. Analgesia was maintained using patient‐controlled epidural analgesia with programmed intermittent epidural boluses. The primary outcome of the study was the quality of labour analgesia, which was defined by a composite of five components: asymmetric block after 30 min of initiation (difference in sensory level of more than two dermatomes); epidural top‐up interventions; catheter adjustment; catheter replacement; and failed conversion to neuraxial anaesthesia for caesarean delivery, requiring general anaesthesia or replacement of the neuraxial block.

Results:

One hundred parturients were included in the analysis (48 combined spinal‐epidural, 52 dural puncture epidural). There were no significant differences between the two groups in the primary composite outcome of quality of analgesia (33% in the combined spinal‐epidural group vs. 25% in the dural puncture epidural group), risk ratio (95%CI) 0.75 (0.40–1.39); p = 0.486. Median (IQR [range]) pain scores at 15 min were significantly lower in patients allocated to the combined spinal‐epidural group compared with the dural puncture epidural group (0 (0–1[0–8]) vs. 1 (0–4 [0–10]); p = 0.018).

Conclusions:

There were no significant differences in the quality of labour analgesia following initiation of a combined spinal‐epidural compared with a dural puncture epidural technique.

01 Jan 2025·ANESTHESIOLOGY

Ultrasound-guided Superficial Cervical Plexus Blocks for Persistent Pain after Suboccipital Craniotomies: A Randomized Trial.

Article

Author: Li, Shu ; Li, Deling ; Zeng, Min ; Sessler, Daniel I ; Zhao, Yan ; Peng, Yuming ; Guan, Xiudong ; Yin, Xueke ; Ren, Yue ; Zheng, Maoyao ; Zhang, Liyong ; Wang, Dexiang

BACKGROUND:

The efficacy of superficial cervical plexus blocks for reducing persistent pain after craniotomies remains unclear. The authors tested the primary hypothesis that preoperative ultrasound-guided superficial cervical plexus blocks reduce persistent pain 3 months after suboccipital craniotomies.

METHODS:

A single-center randomized and blinded parallel-group trial was conducted. Eligible patients having suboccipital craniotomies were randomly allocated to superficial cervical plexus blocks with 10 ml 0.5% ropivacaine or a comparable amount of normal saline. Injections were into the superficial layer of prevertebral fascia. The primary outcome was the incidence of persistent pain three months after surgery.

RESULTS:

From November 2021 to August 2023, a total of 292 qualifying patients were randomly allocated to blocks with ropivacaine (n = 146) or saline (n = 146). The average ± SD age of participating patients was 45 ± 12 yr, and the duration of surgery was 4.2 ± 1.3 h. Persistent pain 3 months after surgery was reported by 48 (34%) of patients randomized to ropivacaine versus 73 (51%) in those assigned to saline (relative risk, 0.66; 95% CI, 0.50 to 0.88; P = 0.003) in the per-protocol population, and by 53 (36%) of patients randomized to ropivacaine versus 77 (53%) in those assigned to saline (relative risk, 0.69; 95% CI, 0.53 to 0.90; P = 0.005) in the intention-to-treat population.

CONCLUSIONS:

Superficial cervical plexus blocks reduce the incidence of persistent incisional pain by about a third in patients recovering from suboccipital craniotomies.

EDITOR’S PERSPECTIVE:

01 Jan 2025·JOURNAL OF ULTRASOUND IN MEDICINE

Effect of Ultrasound‐Guided External Oblique Intercostal Block on Postoperative Recovery After Subxiphoid Video‐Assisted Thoracoscopic Thymectomy

Article

Author: Xi, Yong ; Wang, Lingzhi ; Li, Zhiang ; Hu, Lihong ; Mugaanyi, Joseph ; Zhang, Xuwei

Objective:

Severe postoperative pain can occur after subxiphoid video‐assisted thoracoscopic thymectomy (SVATT), affecting the quality of postoperative recovery. This study aimed to evaluate the effect of ultrasound‐guided external oblique intercostal (EOI) block on recovery after SVATT.

Methods:

A total of 60 patients undergoing SVATT were randomly divided into the EOI group (group E, n = 30) and the control group (group C, n = 30). Group E underwent ultrasound‐guided bilateral EOI block at the 6th rib level and was injected 20 mL of 0.375% ropivacaine on each side. Group C was injected with 20 mL of 0.9% saline at the same site. After the operation, both groups received a patient‐controlled intravenous analgesic (PCIA) pump. The 15‐item Quality of Recovery (QoR‐15) scores were recorded at 24 hours before surgery (T0), 24 hours after surgery (T3), and 48 hours after surgery (T4). The sufentanil usage in the first 24 hours postoperatively, the remifentanil dosage during surgery, the time of first pressing PCIA, and the cases of rescue analgesia were recorded. The visual analog scale (VAS) scores of patients at 6 (T1), 12 (T2), 24 (T3), and 48 hours (T4) after an operation during rest and coughing were recorded. The dermatomes of the sensory plane, block complications in group E, and the incidence of other postoperative adverse reactions in both groups were also recorded.

Results:

Compared with group C, the QoR‐15 scores of patients were significantly higher at T3 and T4 in the group E. The VAS scores were significantly lower at T1, T2, and T3 during rest and coughing in the group E. The sufentanil usage in the first 24 hours postoperatively, the remifentanil dosage during surgery, and the cases of rescue analgesia were significantly lower in group E, and the time of first pressing PCIA was significantly increased in group E (all P < .05).

Conclusion:

Ultrasound‐guided EOI block can be safely used in patients undergoing SVATT, which can improve the quality of postoperative recovery and reduce postoperative pain.

News (Medical) associated with Ropivacaine Hydrochloride

20 Nov 2024

·eupraxiapharma.com

Eupraxia's DiffuSphere™ Technology Demonstrates Targeted Drug Release while Minimizing Systemic Exposure for a Period of More Than Six Months

.q4default span.prnews_span { font-size: 8pt; font-family: "Arial"; color: rgb(0, 0, 0) } .q4default a.prnews_a { color: rgb(0, 0, 255) } .q4default li.prnews_li { font-size: 8pt; font-family: "Arial"; color: rgb(0, 0, 0) } .q4default p.prnews_p { font-size: 0.62em; font-family: "Arial"; color: rgb(0, 0, 0); margin: 0 } DiffuSphere™ is designed to enable precise drug delivery at therapeutic dose levels directly into target tissues, enhancing efficacy while minimizing systemic drug levels to optimize safety In clinical trials, a single administration of DiffuSphere™ successfully delivered fluticasone propionate for at least six months in patients with eosinophilic esophagitis or osteoarthritis DiffuSphere™ has shown its versatility with various drug classes, supporting the possibility to treat multiple types of pain, infectious diseases, eye diseases and cancers VICTORIA, BC, Nov. 20, 2024 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (NASDAQ: EPRX) (TSX: EPRX), a clinical-stage biotechnology company, today unveiled new pharmacokinetic ("PK") data from its Phase 2a Eosinophilic Esophagitis ("EoE") program. Management believes these data underscore the unique capabilities of Eupraxia's proprietary DiffuSphere™ platform technology, which aims to provide precise, localized, safe, and effective long-lasting drug delivery. Most conventional drugs release in a pattern characterized by steep peaks and rapid declines in drug concentration, where peaks often lead to negative side effects, and troughs result in reduced efficacy. In contrast, DiffuSphere™ is a unique microsphere that is designed to enable precise drug release into target tissues with a flat, stable, and long-lasting profile, minimizing potential adverse events associated with high-dose systemic delivery. What sets DiffuSphere™ apart is its composition: a pure drug crystal encased in a microns-thick polymer shell. Eupraxia's proprietary technology uses this polymer to precisely control a drug's release, ensuring high drug concentrations in the target tissues while minimizing exposure to the rest of the body. This innovative approach has been observed in Eupraxia's clinical programs, demonstrating precision, tolerability, and extended duration of delivering fluticasone propionate ("FP") directly to the intended tissues for EoE and knee osteoarthritis ("OA") patients. "Our DiffuSphere™ platform is designed to enable us to deliver the right drug to the right place at the right time with a precise PK profile, aiming to ensure patients receive safe, effective, and durable treatment," said Eupraxia's CEO, Dr. James Helliwell. "We are excited about the broad-based potential of DiffuSphere™. The clinical data from EoE and OA, combined with our extensive non-clinical data showing precise delivery of numerous drugs in a broad array of target tissues, reinforces our optimism." RESOLVE Trial Demonstrates Compelling Pharmacokinetics in the Esophagus DiffuSphere™, when injected into the esophageal wall (submucosa), shows a treatment duration exceeding six months from a single injection, with predictable dose control. In Cohort 1 (4 mg FP), a steady level of 1.5 pg/ml was maintained for at least six months. In Cohort 5 (48 mg FP), 10pg/ml was observed at three months. With this steady, localized, and long-lasting delivery, key EoE disease measures, including patient symptoms, esophageal tissue health, and eosinophil counts, improved. This impact of the DiffuSphere™ technology was clearly demonstrated in a non-clinical study in pigs comparing local and systemic levels of FP after intraesophageal injection of EP-104GI versus oral gavage. Presented at the American College of Gastroenterology meeting (poster), the study revealed that esophageal tissue levels of fluticasone were more than 1000 times higher in the EP-104GI group compared to the oral gavage group, even at distances of several centimeters from the injection sites. Moreover, despite significantly higher local concentrations, systemic levels of fluticasone in the plasma were lower in the EP-104IAR group than in the oral gavage group. This underscores the targeted and precise delivery capabilities of the DiffuSphere™ technology. DiffuSphere™ in the Joint DiffuSphere™ is the technology behind Eupraxia's EP-104IAR for treating OA. In Eupraxia's Phase 2b clinical study, EP-104IAR was well tolerated and showed significantly durable efficacy over placebo. The trial results were recently published in The Lancet, reinforcing the preclinical work previously published in Cartilage. The Phase 2b data showed that EP-104IAR effectively controlled patients' pain for up to 22 weeks (as measured by OARSI Strict Responders) and was well-tolerated. This includes no disruption to blood glucose metabolism (a key factor for diabetics, who comprise almost 40% of the OA population) or adrenal function, which have been reported with other steroid formulations used in this indication. DiffuSphere™ in Other Applications Eupraxia has successfully applied DiffuSphere™ across multiple anatomic locations and drug classes. In preclinical studies, DiffuSphere™ has demonstrated its precise, steady, and tunable delivery traits in intraarticular, intraesophageal, intravitreal, epidural, peritoneal, and subcutaneous applications. Additionally, Eupraxia has demonstrated DiffuSphere's™ capability with local anesthetics such as ropivacaine and various anti-infective agents. The new data in EOE patients further supports DiffuSphere's™ ability to deliver drugs with local precision: stable drug delivery without peaks and troughs, and a customizable duration to fit the clinical indication. This reinforces Eupraxia's confidence in the platform's broad potential. About Eosinophilic Esophagitis (EOE) and the RESOLVE Trial EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview Healthcare Partners, EoE affects more than 450,000 people in the United States and has been identified by the American Gastroenterological Association as rapidly increasing in both incidence and prevalence. Impacts from both symptoms and interventions frequently lead to mental health issues, compounding the disease burden of EoE for both the healthcare system and the individual. RESOLVE is a Phase 1b/2a, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed, active EoE. EP-104GI is administered as a single dose via four to 20 injections into the esophageal wall. Dose escalations increase the dose per site and/or number of sites. Participants in the first through the fourth cohorts will be assessed for up to 24 weeks, and cohorts five and above will be assessed for up to 52 weeks. About Osteoarthritis (OA) Eupraxia's OA product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting disease relief in multiple indications, benefitting from highly localized and longer delivery of corticosteroids. The lead indication is for pain relief in knee OA. The U.S. Centers for Disease Control and Prevention estimates knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer from knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can significantly affect quality of life. With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. The Company believes current therapies are challenged by poor safety, inadequate efficacy and/or limited duration of activity. Corticosteroids are one of only two drug classes strongly recommended by the American College of Rheumatology and the Arthritis Foundation for treating knee OA pain. Currently approved corticosteroids are very effective at reducing pain for a short duration late in the disease but can expose the body to unwanted local and systemic side effects. EP-104IAR is designed to prolong the duration of pain relief with fewer adverse events. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane, part of Eupraxia's patented technology platform. Injected into the knee, EP-104IAR is designed to diffuse the corticosteroid slowly into the knee joint providing local therapeutic concentrations for up to six months. This has the potential dual advantage of providing longer duration of pain relief with fewer systemic adverse events. A robust safety and tolerability profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees by allowing simultaneous treatment of both affected joints. EP-104IAR has also been designed to incorporate additional advantages, such as physician convenience, targeting a long shelf life, no refrigeration and easy integration into existing delivery techniques. About Eupraxia Pharmaceuticals Inc. Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com. Notice Regarding Forward-looking Statements and Information This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as "plans", "is expected", "expects", "aims", "suggests", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes", "potential" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements in this news release include statements regarding the Company's product candidates, including their expected benefits to patients with respect to safety, tolerability, efficacy and duration; additional clinical data from the RESOLVE trial of EP-104GI in EoE, including the Company's intention to periodically disclose such data and timing thereof; the Company's expectations regarding dose-escalating cohorts; the results gathered from studies and trials of Eupraxia's product candidates; the potential for the Company's technology to impact the drug delivery process; potential market opportunity for the Company's products; and potential pipeline indications. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company's clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company's operations; the Company's restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company's common share price; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise. View original content to download multimedia:https://www.prnewswire.com/news-releases/eupraxias-diffusphere-technology-demonstrates-targeted-drug-release-while-minimizing-systemic-exposure-for-a-period-of-more-than-six-months-302311140.html SOURCE Eupraxia Pharmaceuticals Inc. DiffuSphere™ is designed to enable precise drug delivery at therapeutic dose levels directly into target tissues, enhancing efficacy while minimizing systemic drug levels to optimize safety In clinical trials, a single administration of DiffuSphere™ successfully delivered fluticasone propionate for at least six months in patients with eosinophilic esophagitis or osteoarthritis DiffuSphere™ has shown its versatility with various drug classes, supporting the possibility to treat multiple types of pain, infectious diseases, eye diseases and cancers

Clinical ResultPhase 2

11 Nov 2024

·www.prnewswire.com

ResQ Pharma Receives PDUFA Date for LipidRescue™ as a Potential First-Ever, FDA-approved Treatment for LAST

Local Anesthetic Systemic Toxicity (LAST) is a life-threatening event that can result from local anesthetics, such as lidocaine CHICAGO, Nov. 11, 2024 /PRNewswire/ -- ResQ Pharma, Inc., a Chicago-based pharmaceutical company developing and commercializing innovative drug therapies, today announced that it has received a PDUFA (Prescription Drug User Fee Act) date of June 2, 2025, for its LipidRescue Kit. If approved, the kit will treat LAST with the rapid and accurate infusion of a clinically-recommended dose of lipid emulsion that has been shown to safely and effectively counteract toxicity and save patient lives. LAST is an uncommon but potentially fatal event that occurs during the use of local anesthetics. The assignment of a PDUFA date is an important milestone for every new drug application as it indicates that the application is sufficiently complete to permit a substantive review and provides guidance on when the review should be completed. Dr. Guy Weinberg, Founder and President of ResQ Pharma and the inventor of LipidRescue Therapy (LRT) said: "Since discovering more than 25 years ago that lipid emulsion infusion could reverse catastrophic reactions to local anesthetics, I have looked forward to the day that this novel therapy would become a widely available, standardized treatment for a dangerous and potentially fatal condition. As we await potential FDA review and approval, and prepare to launch the LipidRescue Kit, I'm very thankful to the many physicians, researchers, advisors and others who have been allies to ResQ Pharma over the years." Mukesh Kumar of FDAMap in Washington DC consulted on the preparation of the New Drug Application (NDA) for ResQ Pharma and serves as ResQ Pharma's Director of Regulatory Affairs. Michael Gaba, Vice Chair of Polsinelli's FDA practice group, serves as ResQ Pharma's outside FDA counsel. About LAST LAST is a life-threatening event that can occur whenever local anesthetics are used in any of a variety of healthcare settings. Commonly used local anesthetics include lidocaine, bupivacaine, and ropivacaine. Typical early symptoms of LAST include altered mental status (e.g. agitation, confusion, dysphoria) and cardiac instability ( e.g., arrhythmia, hypotension) that can progress to seizures, coma, respiratory or cardiac arrest, and even death. About LipidRescue™ LipidRescue is a soybean oil emulsion that mitigates the toxic effects of local anesthetic overdose. Infusing such an emulsion agrees with guidance for treating LAST published by several professional societies; extensive preclinical literature and more than a hundred published, peer-reviewed case reports support the efficacy and safety of this method. Toxicology studies indicate that LipidRescue is safe with minimal adverse reactions when given according to instructions and dose limits. About the Kit The LipidRescue Kit is a first-of-its-kind drug/device combination comprising both LipidRescue in a quantity sufficient to treat a patient with severe LAST and a purpose-designed administration set to allow rapid and accurate administration of the lipid emulsion through existing vascular access and avoiding use of needles to draw lipid from bags. The kit also contains a quick reference guide with easy-to-read instructions so that time will not be lost in deciding how to administer lipid, when seconds count in saving a life. Infusing lipid emulsion to treat LAST is currently the well-established standard of care as reflected in widely adopted clinical guidelines, ResQ Pharma's NDA proposes the first-ever kit engineered specifically to facilitate safe, uniform, and reliable treatment of LAST. About ResQ Pharma ResQ Pharma, Inc., is a biopharmaceutical company seeking to ensure reliable, global use of LRT, a standard of care for LAST and a potential treatment for various other lipophilic drug overdoses and poisonings. The company was founded by Dr. Guy Weinberg to commercialize the findings of his research on the mechanisms and treatment of local anesthetic toxicity. Dr. Weinberg is a Professor of Anesthesiology at the University of Illinois College of Medicine. He has been honored with several prestigious awards by the anesthesia profession and is a frequent speaker and guest lecturer around the world. The privately-held company is based in Chicago, Illinois. For more information on ResQ Pharma, please visit ResQPharma.com. Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "believes," "potential," "proposed," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, analyses or current expectations concerning, among other things: our expectations regarding the clinical effectiveness and safety of our product candidates and results of studies; and the timing of and our ability to obtain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates and advancing studies for LRT. Any forward-looking statements in this press release speak only as of the date of this press release. Contact: Todd Beck Beck Media & Marketing [email protected] SOURCE ResQ Pharma, Inc. 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NDA

21 May 2024

·www.prnewswire.com

Cali Biosciences Announces Publication of Successful Phase 2 Study Results in Hernia

SAN DIEGO, May 21, 2024 /PRNewswire/ -- Cali Biosciences Co., Ltd. (hereinafter referred to as "Cali Biosciences"), a biotechnology company dedicated to the research and development of innovative drugs, announced publication of "CPL‑01, an investigational long‑acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair" in the scientific journal Hernia. The article's authors are Hanghang Tommy Xu, John Zimmerman, Todd Bertoch, Lee Chen, PJ Chen, and Erol Onel. "Recognition of the importance of these results by an esteemed journal such as Hernia is an important moment for Cali Biosciences," commented lead author, Dr. Tommy Xu. "In this study, our investigational drug CPL-01 out-performed not only placebo, but also standard of care Naropin®, with a clinically meaningful decrease in pain over 72 hours despite using half the opioids." Dr. Erol Onel, the Chief Medical Officer of Cali Biosciences US, LLC, agreed: "While there are several long-acting local anesthetics based on bupivacaine currently available, CPL-01 is based on ropivacaine, which is believed to be safer." The study's lead PI, Dr. Todd Bertoch, reiterated the safety of CPL-01, recounting the lack of serious adverse events in the dose advanced to Phase 3 and agreeing that "the advantages of a more effective and safer long-acting local anesthetic are obvious, and the ability to keep patients out of severe pain and towards an opioid-free recovery benefits society, the hospital systems, and of course the patients themselves." PJ Chen, the CEO of Cali Biosciences, emphasized that "along with our soon-to-be published successful Phase 2 bunion study, these results are incredibly encouraging and we are hopeful that our Phase 3 results will be as successful, leading to positive news from the regulatory authorities. When combined with our other pipeline products in the peri-operative space, Cali Biosciences is positioned to be a leader in this area with a suite of products that could help serve doctors and patients around the world." The publication may be accessed here: CPL-01, an investigational long-acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair | Hernia (springer.com). About CPL-01 CPL-01 is a sustained-release injectable formulation of Naropin® (ropivacaine hydrochloride). Ropivacaine is a member of the amide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and acute pain management. Naropin® injection is approved for local or regional anesthesia for surgery and for acute pain management. However, because of the short duration of effect of the traditional Naropin®, infusion by catheter is required if protracted local analgesia is needed for postoperative pain management. Based on the formulation of Naropin®, Cali Biosciences has applied PG-Depot, a versatile drug delivery platform, in developing CPL-01 to prolong the duration of analgesic effect at local site after a single local administration. About Cali Biosciences Cali Biosciences Co., Ltd. was established in Cayman Islands in 2021. Cali Biosciences US, LLC was established in San Diego in 2016, and later Cali Biosciences built its global headquarter in Shenzhen. Cali Biosciences is a biotechnology company dedicated to the research and development of pain management drug candidates based on its drug delivery platforms and other patented technologies, with a view to extending the coverage to manufacturing and commercialization of the pharmaceutical products it develops. The product pipeline of Cali Biosciences currently focuses on non-opioid post-operative pain management including analgesia, anesthesia, sedation, and control of inflammation. Cali Biosciences is committed to responding to unmet medical needs and serving patients and medical professionals around the world. SOURCE Cali Biosciences

Phase 2Clinical ResultDrug Approval

100 Deals associated with Ropivacaine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04048	Ropivacaine Hydrochloride	N01BB09	DB00296

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Labor Pain	AU	Medis Pharma Pty Ltd.	27 Feb 2013
Pain, Postoperative	JP	Sandoz AG	04 Apr 2001
Acute Pain	NL	Aspen Pharma Trading Ltd.	22 Apr 1996
Anesthesia	NL	Aspen Pharma Trading Ltd.	22 Apr 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Analgesia	Phase 3	CN	Shanghai Hengrui Pharmaceutical Co., Ltd.	21 Mar 2023
Bunion	Phase 3	US	PainReform Ltd.	13 Mar 2023
Hernia, Inguinal	Phase 1	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Oct 2020
Neurolytic Block	Preclinical	TW	Taiwan Liposome Co., Ltd.	01 Nov 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04065009 (Pubmed \| Br J Anaesth)	Phase 3	Ovarian Cancer Adjuvant	225	Ropivacaine 0.2%	tzfuzsljnv(lqbzriodov) = uzmdlblsmt rmrjpmibpy (jsbgaqzudx )	Negative	01 Nov 2024
				Saline 0.9%	tzfuzsljnv(lqbzriodov) = uqmiypizhk rmrjpmibpy (jsbgaqzudx )
NCT05767749 (CTgov)	Phase 4	Anesthesia	75	Ropivacaine+Epinephrine+Lidocaine (Lidocaine+Epinephrine (vs Ropivacaine))	vqbclkscet(ikelgfesrx) = tpzncuftrj ndhveiekpg (dwfondlqeu, hqkhpgbcad - nyyclrirkm) View more	-	19 Sep 2024
				Ropivacaine+Epinephrine+Lidocaine (Ropivacaine (vs Lidocaine+Epinephrine))	vqbclkscet(ikelgfesrx) = nfeaskysto ndhveiekpg (dwfondlqeu, vebxwktbwj - srnlyrfcxt) View more
NCT04773301 (CTgov)	Phase 4	Hip Fractures	114	Levobupivacaine (LEVOBUPIVACAINE)	evvqakwwlh(hdcczyupwm) = nupuvbaoij pvxexvrkow (evninjwxrg, plhufgzwcg - qzarelenfr) View more	-	19 Jul 2024
				ropivacaine (ROPIVACAINE)	evvqakwwlh(hdcczyupwm) = naawrcfown pvxexvrkow (evninjwxrg, yqhsyjcbxw - jtoxbgoeup) View more
ChiCTR2200060364 (not provided, Pubmed \| BMC Anesthesiol)	Phase 4	-	-	0.3% ropivacaine	xrpbpmxhen(zyzjifovnn) = fxfocvncot hckvuxuanv (dshumfqwqx )	Positive	04 Jul 2024
				0.4% ropivacaine	xrpbpmxhen(zyzjifovnn) = xydpmbunnd hckvuxuanv (dshumfqwqx )
NCT04074265 (CTgov)	Phase 4	Hip Dislocation, Congenital \| Pain, Postoperative \| Cerebral Palsy	34	Ropivacaine injection (Pain Injection)	jqyoxzlzlq(pwkjvrojkm) = dappvbgvbt bjedfkdrzp (yhzmehrryl, xkwrjjedwv - pcxnouxcwl) View more	-	10 Jun 2024
				normal saline (Normal Saline)	jqyoxzlzlq(pwkjvrojkm) = jndeyqsyes bjedfkdrzp (yhzmehrryl, zlfecevuhz - eggqrfahfz) View more
PRNewswire Manual	Phase 2	Hernia	-	CPL-01	fpwazbbarh(smqqrleldc) = CPL-01 out-performed not only placebo, but also standard of care Naropin®, with a clinically meaningful decrease in pain over 72 hours despite using half the opioids. erwppeqjmo (kcgwwgxzbk ) View more	Positive	21 May 2024
				standard of care Naropin
ChiCTR2200064350 (not provided, Pubmed \| BMC Anesthesiol)	Phase 1	Neurolytic Block	-	Warming ropivacaine 0.5% at 30℃	rwbnkufuda(wsutwvmxwp) = dyqydibspz rptmpudgen (okbnredwjm, (20 - 24))	Positive	13 Nov 2023
				Room temperature ropivacaine 0.5% at 23℃	rwbnkufuda(wsutwvmxwp) = gckgdeqpva rptmpudgen (okbnredwjm, (24 - 28))
NCT04567407 (CTgov)	Phase 4	Pain, Postoperative	45	Bilateral erector spinae blocks using ropivacaine	ibjupczncc(uckwmyzlyr) = gjarwfazui vabixghwfl (tbfqmgmiub, dgvaivjxxg - cgzsquusad) View more	-	17 Oct 2023

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