Nalmefene Hydrochloride

SOUTH SAN FRANCISCO, CA, UNITED STATES, January 21, 2026 / EINPresswire.com / -- ReacX Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on the development of long-term treatments for substance use disorders, today announced the initiation of a Phase I open-label, dose-escalation clinical study evaluating an investigational nalmefene implant. The Phase 1 clinical study is expected to enroll approximately 24 healthy adult volunteers. The primary objectives of the study are to characterize the pharmacokinetic release profile of the nalmefene implant, and to evaluate its safety and tolerability. The study is not designed to assess clinical efficacy. This clinical trial is supported by a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, under the HEAL Initiative (Helping to End Addiction Long-term ® Initiative). The first-in-human study initiates the clinical development of a six-month nalmefene implant using ReacX’s proprietary ProNeura ® long-term drug delivery technology, which is designed to provide continuous, controlled release of medication over extended periods. The investigational nalmefene implant is being developed as a potential relapse-prevention treatment following opioid detoxification. Nalmefene is an opioid receptor antagonist with established clinical use in injectable and nasal formulations for the acute reversal of opioid overdose. The long-acting subdermal implant formulation is intended to provide sustained opioid receptor blockade for six months. “Nalmefene has an established role in the acute management of opioid overdose, and the investigational nalmefene implant is being developed as a longer-term treatment to prevent relapse in opioid use following detoxification,” said Raj Patel, PhD, Chief Operating Officer of ReacX Pharmaceuticals and Principal Investigator of the NIDA Grant. “This Phase I study is focused on characterizing the pharmacokinetics of release, safety, and tolerability of nalmefene implants to support further clinical development.” The trial is being conducted under an Investigational New Drug (IND) application cleared by the U.S. Food and Drug Administration. Funding support from NIDA is provided as part of the NIH HEAL Initiative, a trans-agency effort to accelerate scientific solutions to the national opioid crisis. For more information about ReacX Pharmaceuticals, visit www.reacxpharma.com . Forward Looking Statements This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. Any forward-looking statement peaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. REACX PHARMACEUTICALS 833-824-0824 dleslie@reacxpharma.com rpatel@reacxpharma.com 400 Oyster Point Blvd, #326, South San Francisco, CA 94080 Rajesh Patel ReacX Pharmaceuticals, Inc +1 650-438-5769 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

U.S. Bankruptcy Judge Sean Lane signed off on the deal on Tuesday after it earned "remarkable consensus" from creditors, according to Purdue. After a legal saga involving thousands of civil lawsuits, a Supreme Court ruling and what was once one of America’s wealthiest families, a U.S. bankruptcy judge has signed off on the $7.4 billion settlement that will close the books on the opioid crisis litigation surrounding Purdue Pharma and its former owners, the Sackler family. U.S. Bankruptcy Judge Sean Lane of the U.S. Bankruptcy Court in the Southern District of New York formally signed off on the plan on Tuesday, mandating the Sacklers to pay up to $7 billion over 15 years, the AP reported. The majority of the money will go to government entities to combat the opioid crisis locally, while a pool of about $850 million designated for individual victims will be distributed next year. Overall, at least $7.4 billion will be doled out to Purdue’s public and private creditors, settlement mediator Willkie Farr & Gallagher explained in an announcement. An additional $500 million could come from the sale of the Sacklers’ international pharmaceutical business. Added cash recoveries are also expected from insurance and other litigation, Purdue said in a Nov. 14 release.“My heart goes out to all those who have suffered such pain,” Lane said in approving the plan, as quoted by AP. “The settlements are fair and equitable and in the best interest of the bankruptcy estates.”The bankruptcy plan achieved a “remarkable consensus” from voting creditors, with more than 99% support, Purdue Pharma pointed out in its release. Purdue issued the release after the court indicated it would approve the plan following a confirmation hearing that involved more than 5,000 pages of testimony and dozens of witnesses.“The Plan is the product of intense work with our creditors through a singular, shared focus on delivering as much value as possible to meaningfully address the opioid crisis,” Purdue board chairman Steve Miller said in a statement. “We are grateful for the perseverance and herculean efforts of our creditors who worked with us to craft an entirely consensual plan that unlocks billions in recoveries and significant non-monetary benefits.”With that, Purdue Pharma will be no more. The company filed for bankruptcy in 2019 after accruing a mountain of litigation for its marketing of opioid-based painkiller OxyContin, a major factor in the nationwide opioid crisis.Purdue’s Chapter 11 bankruptcy reorganization plan dissolves Purdue and transfers its assets to a newly formed company called Knoa Pharma. Knoa will be owned by an independent foundation and provide millions of doses of opioid use disorder treatments and overdose reversal meds with “no obligation to maximize profits,” according to Purdue.The Sacklers haven’t had formal involvement with Purdue for years, with the last member of the Sackler family to sit on the company’s board stepping down at the start of 2019.  The family will continue to have “no interest or role in” the new company, which will be subject to a “strict operating injunction” and overseen by a monitor to ensure it provides its products safely, according to the plan.The plan also mandates a document repository that exposes millions of documents related to Purdue’s historical sales and marketing practices. Purdue was required to emerge from its bankruptcy as a public benefit company by the U.S. Justice Department in 2020, when Purdue agreed to plead guilty to felony charges tied to its misleading OxyContin marketing. Since then, the company has been making efforts to restore its public image. Last year, it won an FDA approval for its emergency opioid overdose rescue treatment Zurnai, an nalmefene injection.The Sacklers, meanwhile, previously came out of years of negotiations with a proposed $6 billion settlement that would have granted them legal immunity from civil lawsuits. That plan went through numerous courts before being knocked down by the U.S. Supreme Court, which determined that the Sacklers, who had not themselves filed for bankruptcy, weren’t eligible for protection from current and future litigation.The new, now-confirmed bankruptcy settlement is the largest U.S. opioid related settlement with individuals to date. Other billion-dollar settlements have come from drugmakers and drug distributors also involved in the opioid crisis, such as Johnson & Johnson, AmerisourceBergen, Cardinal Health and McKesson’s $26 billion deal in 2022 or Teva’s $4.25 billion settlement in the same year.