Hydrocodone controlled release(DURECT Corp)

SMART™ opioid prodrugs leverage Elysium's O2P (Oral Overdose Protected) technology to effectively mitigate non-oral and oral abuse while safely delivering FDA-cleared opioid agonists, which continue to play a vital role in the treatment of acute pain Phase 1 results demonstrated effective acute pain relief while simultaneously mitigating the major risks of existing opioids by protecting against abuse, diversion, and fatal overdose LYONS, Colo., Sept. 3, 2024 /PRNewswire/ -- Elysium Therapeutics, an emerging biopharmaceutical company establishing new standards for safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines to address the limitations and dangers associated with opioids and overdose rescue agents, today announced its Phase 1, human-proof-of-concept study investigating the company's proprietary Oral Overdose Protected (O2P™) hydrocodone prodrug for the treatment of moderate-to-severe acute pain will be presented at PAINWeek 2024 being held September 3-6 in Las Vegas. The poster titled, "SMART™ Opioids with Unprecedented Protection Against Abuse and Oral Overdose – Human Proof-of-Concept", evaluates the safety, tolerability, and pharmacokinetics of oral O2P Hydrocodone relative to a hydrocodone bitartrate (HCBT) comparator following single oral doses in healthy adult subjects. The presentation of the successful Phase 1 study outlines a promising and novel approach, providing effective acute pain relief while simultaneously mitigating the major risks of existing opioids by protecting against abuse, diversion, and fatal overdose. The Phase 1 study achieved several key milestones, demonstrating a significant reduction in the number of prescribed doses that mitigates misuse, abuse, and diversion. Additionally, the authors were able to show that oral O2P Hydrocodone has the potential to limit the number of euphoric experiences that may serve to initiate and reinforce abusive behavior. "A key finding we look forward to presenting is the sustained plasma exposure of hydrocodone with O2P Hydrocodone, which is consistent with a once-daily dosing regimen," said Tom Jenkins, Ph.D., Co-Founder and Chief Scientific Officer of Elysium Therapeutics and inventor of trypsin-activated opioid prodrugs and concomitant use of trypsin inhibition to govern opioid exposure. "As a consequence, we anticipate being able to significantly reduce the number of prescribed tablets for O2P Hydrocodone compared to currently prescribed hydrocodone. Additionally, the O2P Hydrocodone technology is designed to attenuate hydrocodone exposures when supratherapeutic doses are ingested dramatically reducing the number of euphoric experiences available from an O2P Hydrocodone prescription." "Elysium is on a mission to establish a new standard of safety in the opioid industry, so we look forward to presenting our Phase 1 Proof-of-Concept findings for our O2P Hydrocodone technology, which we believe can significantly reduce the risk of fatal overdoses while providing the unmatched effective management of acute pain possible with opioid treatment," said Greg Sturmer, Co-Founder and CEO of Elysium Therapeutics. "For decades, as the opioid crisis has ravaged the nation, drug developers have largely failed to bring effective solutions for pain management to the clinic that offer a solution to the broader problems of abuse. We believe O2P Hydrocodone can be an important step in bringing solutions to this immense challenge." Poster Information: Title: SMART™ Opioids with Unprecedented Protection Against Abuse and Oral Overdose – Human Proof-of-Concept Authors: T. Jenkins, Ph.D., Lynn R. Webster, M.D., Leela Vrishabhendra, M.D., A. Greg Sturmer Time & Location: PAINWeek 2024, September 3-6 at The Cosmopolitan of Las Vegas About O2P™ Hydrocodone Elysium's lead product candidate – oral-overdose protected (O2P) hydrocodone – is a hydrocodone prodrug being developed for the treatment of moderate-to-severe acute pain. Elysium leverages its proprietary bifunctional prodrug technology, containing a trypsin-activated opioid delivery subunit that efficiently releases therapeutic levels of hydrocodone when exposed to the digestive enzyme trypsin in the lumen of the small intestine, and a trypsin inhibitor subunit that progressively inhibits trypsin, attenuating the release of hydrocodone when supratherapeutic doses are ingested. About the Phase 1 O2P-001 Study O2P-001 was a Phase 1, human proof-of-concept, randomized, open-label, two-part study designed to evaluate the safety and pharmacokinetics of O2P hydrocodone in healthy adult subjects. The key objectives of the study were to (i) evaluate the safety, tolerability, and pharmacokinetics of O2P hydrocodone relative to a hydrocodone comparator following single oral doses in healthy adult subjects with naltrexone blockade; and (ii) demonstrate reduced dose-proportional plasma exposures of hydrocodone (i.e., oral overdose protection) of O2P hydrocodone relative to an escalated comparator dose of hydrocodone. A total of 93 subjects were enrolled in the study. About Elysium Therapeutics Elysium is an emerging biopharmaceutical company that is establishing new standards of safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines that address the limitations and dangers associated with opioids and overdose rescue agents to reduce suffering from opioid-use disorder, opioid overdose, and acute pain. Elysium's lead SMART opioid product candidate – oral-overdose protected (O2P™) hydrocodone – is being developed for the treatment of moderate-to-severe acute pain. Elysium is also developing its SMART rescue medicine, SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), a long-acting opioid antagonist specifically designed to address oral synthetic opioid, including fentanyl, overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including naloxone and nalmefene. For more information, please visit . SOURCE Elysium Therapeutics

Vertex Pharmaceuticals’ application seeking approval of its non-opioid analgesic suzetrigine (VX-548) to treat moderate-to-severe acute pain has been accepted by the FDA under priority review, with a target action date set for January 30 next year. A rolling submission to the agency for the oral selective NaV1.8 pain signal inhibitor was initiated in April.Highlighting “the high unmet need in treating acute pain” and the “known risks, including addictive potential” of opioids, Nia Tatsis, chief regulatory and quality officer at Vertex, said the “FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients.” The application is backed by findings from two Phase III studies, involving 1118 and 1073 patients with moderate-to-severe pain after abdominoplasty and bunionectomy, respectively. Results showed that while suzetrigine beat placebo in reducing pain intensity, it failed to demonstrate superiority over the hydrocodone bitartrate/acetaminophen combination. Despite mixed results, chief medical officer Carmen Bozic said, at the time, that the company would proceed with regulatory submissions given the drug’s favourable benefit/risk profile across the programme and the positive interactions with regulators. In a FirstWord poll of 100 physicians conducted earlier this year, 62% of respondents said if approved, they would consider prescribing suzetrigine as an alternative to opioids based on the available data, despite any 'reasonable' cost differential.Earlier this week, the Institute for Clinical and Economic Review (ICER) announced it would evaluate the comparative effectiveness and value of the Vertex drug, with a public discussion on the assessment and a panel vote on the evidence scheduled for February next year.Besides the acute pain programme, Vertex plans to initiate a late-stage study of suzetrigine for diabetic peripheral neuropathy later in the year, following a positive Phase II readout in December that showed efficacy comparable to Viatris' Lyrica (pregabalin).