Pain Management in Cardiac Implantable Electronic Device Insertion; Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain

Bupivacaine is the most widely used local anesthetic agent across majority of the Cardiac Implantable Electronic device (CIED) implant procedures in the United States. It is hypothesized that the combination of Bupivacaine-Ketorolac-Ketamine (BKK) is more effective in alleviating perioperative and postoperative pain as compared to the use of bupivacaine alone.
A few studies have been done to look for the effectiveness of BKK in abdominal surgical procedures. However, no study has been done to evaluate its efficacy and effectiveness in patients undergoing CIED insertion.

Start Date01 Jan 2025

Sponsor / Collaborator

Loma Linda University Adventist Health Sciences Center

CTRI/2024/10/075510 / Not yet recruitingNot ApplicableIIT

Comparison of the effect of calcium hydroxide mixed with bupivacaine hydrochloride and calcium hydroxide mixed with saline on postoperative pain in teeth with irreversible pulpitis and symptomatic apical periodontitis: A randomized controlled single blind trial. - NIL

Start Date15 Nov 2024

Sponsor / Collaborator-

NCT04895280 / WithdrawnPhase 4IIT

Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections: a Prospective Double-Blinded Randomized Trial

The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid.
Specific Aim 1:
Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies.
The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.

Start Date01 Nov 2024

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

100 Clinical Results associated with Bupivacaine Hydrochloride

100 Translational Medicine associated with Bupivacaine Hydrochloride

100 Patents (Medical) associated with Bupivacaine Hydrochloride

884

Literatures (Medical) associated with Bupivacaine Hydrochloride

01 Dec 2024·Journal of Clinical Anesthesia

Simulated bupivacaine pharmacokinetics after labor epidural analgesia followed by transversus abdominis plane block with liposomal bupivacaine for intrapartum cesarean delivery

Article

Author: Winston, Roy ; Song, Jia ; Landau, Ruth ; Katz, Daniel ; Carangelo, Matthew ; Bergsma, Timothy

STUDY OBJECTIVETo simulate bupivacaine pharmacokinetics in scenarios of labor epidural analgesia (LEA) extended for intrapartum cesarean delivery (CD) with epidural or intrathecal boluses, followed by transversus abdominis plane (TAP) block with liposomal bupivacaine (LB) for postcesarean analgesia.DESIGNBupivacaine plasma concentrations were simulated using a 2-compartment distribution model fit to previous study data.SETTINGVirtual pharmacokinetic simulations.PATIENTSVirtual individuals (1000, each scenario) had uniform weight (80 kg) but varying absorption parameters.INTERVENTIONSThe 6 scenarios varied in LEA infusion duration (6 or 24 h), local anesthetic used for bolus to extend LEA (epidural lidocaine or intrathecal bupivacaine), TAP block regimen, and time between bolus and TAP block.MEASUREMENTSScenario outcomes included geometric mean (GM) peak bupivacaine plasma concentration (C_max) with 95% prediction interval (PI), median (range) C_max, and number of virtual individuals (per 1000) with C_max reaching estimated toxicity thresholds (neurotoxicity: 2000 μg/L; cardiotoxicity: 4000 μg/L).MAIN RESULTSIn simulated scenarios of LEA infusion for 24 h with an epidural bolus of lidocaine 400 mg for CD followed 1 h later by TAP block, the GM C_max for the scenarios with TAP blocks including either LB 266 mg plus bupivacaine hydrochloride 52 mg or bupivacaine hydrochloride 104 mg was 1860 (95% PI, 1107-3124) and 1851 (95% PI, 1085-3157) μg/L, respectively. Among 1000 virtual individuals for each scenario, 404 and 401 had C_max reaching 2000 μg/L, respectively; 1 and 0 had C_max reaching 4000 μg/L, respectively. For other scenarios, GM C_max remained <1000 μg/L.CONCLUSIONSAcross 6 different simulations of TAP blocks for intrapartum CD analgesia, LEA with bupivacaine (with or without boluses for extension and including a conservative modeling of lidocaine without epinephrine), followed by TAP block with LB and/or bupivacaine hydrochloride 0, 1, or 2 h after CD, is unlikely to result in bupivacaine plasma concentrations reaching local anesthetic systemic toxicity thresholds in healthy patients.

01 Dec 2024·Techniques in Coloproctology

Liposomal bupivacaine versus conventional anesthetic or placebo for hemorrhoidectomy: a systematic review and meta-analysis

Review

Author: La, K ; Schleicher, M ; Cohen, J ; Barnajian, M ; Oka, K ; Nasseri, Y ; Termeie, O ; Solis-Pazmino, P ; Figueroa, L

AbstractBackgroundLiposome bupivacaine (LB) is a long-acting anesthetic to enhance postoperative analgesia. Studies evaluating the efficacy of the LB against an active comparator (bupivacaine or placebo) on acute postoperative pain control in hemorrhoidectomy procedures are few and heterogeneous. Therefore, we performed a systematic review and meta-analysis comparing LB’s analgesic efficacy and side effects to conventional/placebo anesthetic in hemorrhoidectomy patients.MethodsWe performed a systematic review and meta-analysis of randomised controlled trials investigating the use of LB after haemorrhoidectomy. We searched the literature published from the time of inception of the datasets to August 19, 2022. The electronic databases included English publications in Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, and Scopus.ResultsA total of 338 patients who underwent a hemorrhoidectomy procedure enrolled in three randomized clinical trials were included. The overall mean age was 45.84 years (SD ± 11.43), and there was a male predominance (53.55% male). In total 194 patients (52.2%) received LB and 144 (47.8%) received either bupivacaine or placebo. Pain scores at 72 h in the LB (199, 266, and 300 mg) were significantly lower than in the bupivacaine HCl group (p = 0.002). Compared to the bupivacaine/placebo group, the time to first use of opioids in the LB group was significantly longer at LB 199 mg (11 h vs. 9 h), LB 266 mg (19 h vs. 9 h), and LB 300 mg (19 h vs. 8 h) (p < 0.05). Moreover, compared to the bupivacaine/epinephrine group, it was significantly lower in the LB 266 mg group (3.7 vs. 10.2 mg) and at LB 300 mg (13 vs. 33 mg) (p < 0.05). Finally, regarding adverse effects, the conventional anesthetic/placebo group reported more pain in bowel movement than LB groups (OR 2.60, 95% CI 1.31–5.16).ConclusionsComparing LB to conventional anesthetic/placebo anesthetic for hemorrhoidectomy, we found a statistically significant reduction in pain through 72 h, decreased opioid requirements, and delayed time to first opioid use. Moreover, the conventional anesthetic/placebo group reported more pain in bowel movement than LB groups.

01 Dec 2024·Journal of Controlled Release

Controlled dual drug release from adhesive electrospun patches for prevention and treatment of alveolar osteitis

Article

Author: Edwards, Sean M ; Edmans, Jake G ; Colley, Helen E ; Murdoch, Craig ; Hatton, Paul V ; Slowik, Klaudia M ; Bolt, Robert ; Harrison, Samuel ; Spain, Sebastian G

Approximately one in five individuals experience alveolar osteitis (AO) following wisdom tooth extraction. AO is characterised by loss of the blood clot from the tooth extraction socket leading to infection and pain, resulting in repeated hospital visits that impose a substantial burden on healthcare systems. Current treatments are sub-optimal; to address this we developed a novel drug-loaded mucoadhesive patch composed of dual electrospun polyvinyl pyrrolidone/Eudragit RS100 (PVP/RS100) and poly(N-isopropylacrylamide) (PNIPAM) fibres protected by a poly(ε-caprolactone) (PCL) backing layer. These patches demonstrated controlled release of the long-acting analgesic bupivacaine HCl and the anti-inflammatory drug prednisolone. Topical application of patches to tissue-engineered gingival mucosa showed that patch-released bupivacaine and prednisolone achieved sustained tissue permeation with 54.8 ± 3.3 % bupivacaine HCl and 65.8 ± 5.1 % prednisolone permeating the epithelium after 24 h. The drugs retained their functionality after release; bupivacaine HCl significantly (p < 0.05) inhibited veratridine-induced intracellular calcium flux in SH-SY5Y neuronal cells, while prednisolone significantly reduced gene expression of IL-6 (2-fold; p < 0.001), CXCL8 (5.1-fold; p < 0.01) and TNF-α (1.5-fold; p < 0.001) in stimulated THP-1 monocytes. Taken together, these data show that dual electrospun patches have the potential to provide a mucoadhesive covering to prevent blood clot loss while delivering pain relief and anti-inflammatory therapeutics at tooth extraction sites to prevent and treat AO. This study not only offers a future therapeutic pathway for AO but also contributes valuable insights into future advancements in drug delivery devices for periodontal or oral mucosal tissue.

News (Medical) associated with Bupivacaine Hydrochloride

13 Nov 2024

·www.prnewswire.com

DURECT Corporation Reports Third Quarter 2024 Financial Results and Provides Business Update

- Seeking to initiate Phase 3 registrational trial for larsucosterol with topline results expected within two years of initiation - Webcast of Earnings Call Today, November 13 at 4:30 p.m. ET CUPERTINO, Calif., Nov. 13, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended September 30, 2024 and provided a business update. "We remain focused on preparations for the Phase 3 trial for larsucosterol in severe alcohol-associated hepatitis (AH), including discussions with U.S. clinical sites and hepatologists, to streamline the initiation process," stated James E. Brown, D.V.M., President and CEO of DURECT. "Our goal is to begin the trial as soon as possible, subject to obtaining sufficient funding, which should enable us to report topline data within two years of trial initiation. If successful, the FDA has agreed that a single Phase 3 trial may be sufficient to support a New Drug Application (NDA). We believe the selected primary endpoint of 90-day survival is clinically meaningful and provides the greatest probability of success based on the Phase 2b AHFIRM data. We look forward to initiating the trial as soon as possible. We believe that larsucosterol, if approved, could provide physicians with a much-needed treatment that could significantly improve the current 90-day mortality rates of approximately 30%." Recent business highlights and updates: DURECT announced details on the design of its planned registrational Phase 3 trial to evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH). The trial will be a randomized, double-blind, placebo-controlled, multi-center study conducted in the U.S. The primary endpoint will be 90-day survival. The trial design incorporates feedback we received from the U.S. FDA during a Type B meeting held under Breakthrough Therapy Designation (BTD) as well as learnings from our prior Phase 2b AHFIRM trial in AH. DURECT's goal is to begin the trial as soon as possible, subject to obtaining sufficient funding, with topline results expected within two years of trial initiation. DURECT plans to deliver an oral and two poster presentations at The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD), to be held November 15-19, 2024 in San Diego, California. These presentations will showcase additional data from the completed Phase 2b AHFIRM trial which evaluated larsucosterol for the treatment of alcohol-associated hepatitis (AH). The data further support the design of the Company's planned Phase 3 trial of larsucosterol, including the importance of timely treatment in clinical outcomes. Top line data from AHFIRM were previously announced in November 2023. On November 8, 2024, DURECT received notice that Innocoll Pharmaceuticals is terminating its license agreement for POSIMIR® (bupivacaine solution), effective in May 2025. Innocoll has committed to transfer all data and know-how related to POSIMIR to DURECT, and the company is evaluating next steps with respect to the commercialization of POSIMIR. Financial Highlights for Q3 2024: Total revenues were $1.9 million and net loss was $4.3 million for the three months ended September 30, 2024 compared to total revenues of $1.7 million and net loss of $3.0 million for the three months ended September 30, 2023. Cash, cash equivalents and investments were $10.5 million at September 30, 2024, compared to $29.8 million at December 31, 2023. Debt at September 30, 2024 was $10.5 million, compared to $16.7 million at December 31, 2023. Earnings Conference Call We will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss the Third Quarter 2024 results and provide a corporate update: Participants can use guest dial-in numbers above to reach an operator or they can click the Call me™ link for instant telephone access to the event (dial-out). The Call me™ link will be made active 15 minutes prior to the scheduled start time. The live audio webcast of the presentation will be also available on DURECT's homepage at on the "Events" page, under the "Investors" section. If you are unable to participate during the live webcast, the call will be archived on DURECT's website under the same section, following the completion of the call. About the AHFIRM Trial AHFIRM was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study conducted in subjects with severe alcohol-associated hepatitis ( AH) to evaluate the sa Fety and eff Icacy of la Rsucosterol treat Ment (AHFIRM). The study was comprised of three arms and enrolled 307 patients, with approximately 100 patients in each arm: (1) Placebo, which consists of standard of care, with or without methylprednisolone capsules at the investigators' discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. The primary outcome measure was the 90-day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo, and the key secondary endpoint was 90-day survival. The Company enrolled patients at clinical trial sites across the U.S., EU, U.K., and Australia. In November 2023, the Company announced topline data for the AHFIRM Trial. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation and Breakthrough Therapy Designation for the treatment of AH. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026. About Alcohol-associated Hepatitis (AH) AH is an acute form of alcohol-associated liver disease (ALD) associated with long-term heavy alcohol intake, often following a recent period of increased consumption (i.e., a binge). AH is typically characterized by severe inflammation and liver cell damage, potentially leading to life-threatening complications including liver failure, acute kidney injury and multi-organ failure. There are no FDA approved therapies for AH, and a retrospective analysis of 77 studies published between 1971 and 2016, which included data from 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median Model of End-Stage Liver Disease (MELD) score of 23.5, reported mortality at 28 and 90 days of approximately 20% and 31%, respectively. Stopping alcohol consumption is necessary, but frequently not sufficient for recovery in many moderate (defined as MELD scores of 11-20) and severe (defined as MELD scores >20) patients, and therapies that reduce liver inflammation, such as corticosteroids, are limited by contraindications, have not been shown to improve survival at 90 days or one year, and have demonstrated an increased risk of infection. While liver transplantation is becoming more common for ALD patients, including AH patients, the total number of such transplants is still relatively small, and limited by organ availability. Average charges for a liver transplant exceed $875,000, and patients require lifelong immunosuppressive therapy to prevent organ rejection. About Larsucosterol Larsucosterol is an endogenous sulfated oxysterol and an epigenetic modulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been reported in many acute (e.g., AH) and chronic diseases (e.g., MASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently modulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic modulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases. About DURECT Corporation DURECT is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH is also being explored. In addition, POSIMIR®(bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER®platform technology, is FDA-approved. For more information about DURECT, please visit and follow us on X (formerly Twitter) at . DURECT Forward-Looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: the Company's ability to commence a Phase 3 trial of larsucosterol and report top-line data within two years of initiation, the potential for a single Phase 3 trial of larsucosterol, if successful, to support an NDA filing, and the potential uses and benefits of larsucosterol in patients with AH and potentially other indications. Actual results may differ materially from those contained in the forward-looking statements contained in this press release, and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risks that the Company is unable to raise sufficient capital to commence the Phase 3 trial of larsucosterol in AH, trial enrollment or completion takes longer than anticipated, future clinical trials of larsucosterol are delayed or do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterol in a statistically significant manner; the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for the treatment of AH, and that larsucosterol may never be approved; and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our need or desire for additional financing, our ability to continue to meet the minimum bid price for continued listing on Nasdaq, our ability to obtain capital to fund our operations and expenses, and our ability to continue to operate as a going concern. Further information regarding these and other risks is included in DURECT's most recent Securities and Exchange Commission (SEC) filings, including its annual report on Form 10-K for the year ended December 31, 2023 and quarterly report on Form 10-Q for the quarter ended September 30, 2024, when filed, under the heading "Risk Factors." These reports are available on our website under the "Investors" tab and on the SEC's website at . All information provided in this press release and in the attachments is based on information available to DURECT as of the date hereof, and DURECT assumes no obligation to update this information as a result of future events or developments, except as required by law. NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd. in the U.S. and a trademark of DURECT Corporation outside of the U.S. SABER® is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. Larsucosterol is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. SOURCE DURECT Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Breakthrough TherapyPhase 3Fast TrackClinical Result

06 Nov 2024

·www.prnewswire.com

DURECT Corporation to Announce Third Quarter 2024 Financial Results and Provide a Business Update

CUPERTINO, Calif., Nov. 6, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions, including acute organ injury, today announced that the company will report its third quarter financial results on Wednesday, November 13, 2024. Management will also host a conference call and webcast with investors to discuss financial results and provide a corporate update at 4:30 pm Eastern Time. Details for the call are as follows: Wednesday, November 13th @ 4:30 pm Eastern Time / 1:30 pm Pacific Time Participants can use guest dial-in numbers above to reach an operator or they can click the Call meTM link for instant telephone access to the event (dial-out). The Call me™ link will be made active 15 minutes prior to the scheduled start time. About DURECT Corporation DURECT is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH is also being explored. In addition, POSIMIR®(bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER®platform technology, is FDA-approved and is exclusively licensed to Innocoll Pharmaceuticals for sale and distribution in the United States. For more information about DURECT, please visit and follow us on X (formerly Twitter) at . DURECT Forward-Looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: our plans to report third quarter financial results on November 13, 2024 and the potential for larsucosterol to treat AH. Actual results may differ materially from those contained in the forward-looking statements contained in this press release, and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risk that we do not raise sufficient capital to commence or complete the Phase 3 trial of larsucosterol in patients with AH or continue to fund our operations, the risk that future clinical trials of larsucosterol are delayed or do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterol in a statistically significant manner; the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for the treatment of AH, the risk that Breakthrough Therapy designation does not expedite the process for FDA approval and that larsucosterol may never be approved; and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our our ability to continue to meet the minimum bid price for continued listing on Nasdaq, and our ability to continue to operate as a going concern. Further information regarding these and other risks is included in DURECT's most recent Securities and Exchange Commission (SEC) filings, including its annual report on Form 10-K for the year ended December 31, 2023, and quarterly report on Form 10-Q for the quarter ended September 30, 2024, when filed, under the heading "Risk Factors." These reports are available on our website under the "Investors" tab and on the SEC's website at . All information provided in this press release and in the attachments is based on information available to DURECT as of the date hereof, and DURECT assumes no obligation to update this information as a result of future events or developments, except as required by law. NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd. in the U.S. and a trademark of DURECT Corporation outside of the U.S. SABER® is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. Larsucosterol is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. SOURCE DURECT Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Breakthrough TherapyFinancial StatementPhase 3Fast TrackAccelerated Approval

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

100 Deals associated with Bupivacaine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01450	Bupivacaine Hydrochloride	N01BB01	DBSALT001512

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain, Postoperative	US	Innocoll Pharmaceuticals Ltd.	28 Aug 2020
Anesthesia	JP	Sandoz KK	03 Sep 1969

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain	Phase 2	US	Pacira Biosciences, Inc.	01 Nov 2008
Hernia, Ventral	Preclinical	US	Innocoll Holdings, Inc.	14 Apr 2021
Uterine Neoplasms	Preclinical	US	Innocoll Holdings, Inc.	14 Apr 2021
Hernia, Inguinal	Preclinical	US	Innocoll Pharmaceuticals Ltd.	16 Jun 2017
Bunion	Preclinical	US	Pacira Biosciences, Inc.	01 Apr 2009
Hallux Valgus	Preclinical	US	Pacira Biosciences, Inc.	01 Apr 2009
Pain	Preclinical	US	Pacira Biosciences, Inc.	01 Nov 2008
Hemorrhoids	Preclinical	US	Pacira Biosciences, Inc.	01 Aug 2008
Hernia	Preclinical	NZ	DURECT Corp.	01 Jan 2007
Neuralgia, Postherpetic	Preclinical	US	DURECT Corp.	01 Sep 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04777591 (CTgov)	Phase 4	Pain, Postoperative	117	Bupivacain (Control - Plain Bupivacaine)	zucjnwsmjs(npydcvdkrw) = wfitaozbvw syoolbeklg (iicqiommnb, upphfbluaz - eykgvprsrl) View more	-	23 Aug 2024
				bupivacain+Liposomal bupivacaine TAP block (Experimental - Liposomal Bupivacaine)	zucjnwsmjs(npydcvdkrw) = voqygxnwoa syoolbeklg (iicqiommnb, slckzliabb - zxxzapovmt) View more
NCT04814433 (CTgov)	Phase 4	Pain, Postoperative	46	Lidocaine Hydrochloride+Epinephrine+Bupivacaine Hydrochloride (Topical Lidocaine and Bupivacaine Alone)	oirqsaavoq(nhlyiazjby) = fpohvtqbal llqeosyuts (vjfqmnfdiq, gemjmhobws - gmyoptndjx) View more	-	26 Jun 2024
				Recombinant Human Thrombin+Lidocaine Hydrochloride+Epinephrine+Bupivacaine Hydrochloride (Topical Lidocaine and Bupivacaine With Thrombin)	oirqsaavoq(nhlyiazjby) = blfznzvzcx llqeosyuts (vjfqmnfdiq, arzhnbdrrs - bhkknnhjgg) View more
NCT04530149 (CTgov)	Phase 4	Rib Fractures \| Pain	3	Acetaminophen+Bupivacain	aiyrmtvely(csjhqauuhs) = zzjzbxriib mktsamgzuy (xvznppgdyr, fwveterlww - gizedfxlsx) View more	-	11 Jun 2024
NCT03261193 (qlcsection, CTgov)	Phase 3	Pain, Postoperative	21	ITM + Sham QLB (ITM + Sham QLB)	vmnnoxleox(ejfqktlmeg) = fwjgyhynta embgihqkac (wniofrzgmf, ihrxfftafn - mqwngdsmqk) View more	-	06 May 2024
				ITM+Bupivacaine (ITM + Bupivacaine QLB)	vmnnoxleox(ejfqktlmeg) = pyrgqegltw embgihqkac (wniofrzgmf, mfzpeuqhql - oavcpksrsx) View more
NCT02865928 (CTgov)	Phase 4	Breast Diseases \| Pain, Postoperative	42	normal saline (Normal Saline)	rnnggvptak(ggpzamtzdh) = tvkiusljwo mcvgbyldub (qhbxpybwmn, qzhevyansc - yxphvaysbu) View more	-	22 Feb 2024
				Bupivicaine HCl (Bupivicaine HCl)	dcthqvvfuq(noquzsyljx) = rsfyqzyyyj zvokmlhlfj (htwlfjbfkq, pznozsteep - aamfblqqbn) View more
NCT04826484 (Baby ORIOLES, CTgov)	Phase 3	Pain \| Cryptorchidism \| Testicular Hydrocele \| Urologic Diseases \| Gryposis penis \| Hypospadias	104	Exparel 133 miligrams per 10 milliliter injection+Bupivacaine Hydrochloride (Liposomal Bupivacaine Plus 0.25% Bupivacaine)	aagukklyko(nxgjhptubn) = vttwwqhqmm rlzieaooxs (jmhaesnpyu, zmqobackfr - fbwwjuqzzw) View more	-	26 Dec 2023
				Bupivacaine Hydrochloride (0.25% Bupivacaine Alone)	aagukklyko(nxgjhptubn) = tsdcccenob rlzieaooxs (jmhaesnpyu, midpcywevz - thqjghtvgk) View more
NCT05005260 (CTgov)	Phase 4	occlusions \| Pain, Postoperative	88	Bupivacaine Hcl+Liposomal bupivacaine (Liposomal Bupivacaine Single-shot Interscalene Blockade)	cmbqyjhgbv(zaeqeremmb) = dbkgvgwxvf wivzaljftr (ovhduusrmc, fvwjkzcwok - pyvbppsttk) View more	-	18 Dec 2023
				Bupivacaine HCl (Continuous Interscalene Nerve Blockade)	cmbqyjhgbv(zaeqeremmb) = cxjthpyxix wivzaljftr (ovhduusrmc, ejktiqordm - tltuipegbp) View more
NCT04897841 (OBLiBupi, CTgov)	Phase 4	Pain \| complications of cesarean section	60	Bupivacaine Hydrochloride+saline (Control Arm)	mrqikrzbua(xvxhzsntkv) = odhcwhsieo mlweybqebv (ahosjspkkm, hgcbqftpov - aaenzauxlg) View more	-	30 Oct 2023
				Bupivacaine Hydrochloride+saline+Liposomal Bupivacaine (Intervention: Liposomal Bupivacaine)	mrqikrzbua(xvxhzsntkv) = nefkfwvtfm mlweybqebv (ahosjspkkm, sfsgnqkgsb - sttfcyehyr) View more
NCT02513329 (CTgov)	Phase 2	Vasomotor symptom \| Hot Flashes \| Breast Cancer	37	bupivicaine (Bupivicaine)	kuxwckkfde(wxcxlhmfzh) = ogjfnwrzuh aipsmiptds (ryebgaeqlz, ndhktxdeng - aidbsqyhgq) View more	-	05 Jun 2023
				Saline (Saline)	kuxwckkfde(wxcxlhmfzh) = cgqkyyydfo aipsmiptds (ryebgaeqlz, tlcdsvequo - weckhlfwrx) View more
NCT03702621 (CTgov)	Phase 3	-	90	liposomal Bupivacaine (Liposomal Bupivacaine)	juuxytxhab(udgfuruylh) = ihmfgekrtv mahwlcjwcg (rtsahmmaoy, elckpscgdi - achhvjqwsn) View more	-	17 May 2023
				Bupivacaine Hydrochloride (Standard Bupivacaine)	juuxytxhab(udgfuruylh) = jdzxhebxuh mahwlcjwcg (rtsahmmaoy, cdkrarlbxu - wmfiibpabb) View more

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