Methadone Hydrochloride

STAMFORD, Conn.--(BUSINESS WIRE)-- Purdue Pharma L.P. (“Purdue”) announced today that the Company has awarded an investigator-initiated research (IIR) grant to a team of researchers at The University of New Mexico (UNM) for the evaluation of nalmefene hydrochloride (HCl) injection 2mg/2mL (1mg/1mL) in the emergency department setting. “Opioid overdoses are sadly way too common in New Mexico,” said Cameron Crandall, MD, with UNM’s School of Medicine, Department of Emergency Medicine. “Having this treatment available can help save lives. Nalmefene helps reverse the deadly effects of opioid overdoses and is long-acting. We are evaluating its effects on patients who present in the ED with opioid overdose.” “Investigator-initiated research projects like this can help provide a better understanding of nalmefene HCI injection’s use in real-world emergency department settings,” said Monica Kwarcinski, PharmD, Vice President, Medical Affairs at Purdue. “We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.” The prospective, randomized study, “Evaluation of Nalmefene HCl Injection for Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in an Emergency Department,” will compare the efficacy and safety of nalmefene HCl injection to naloxone injection in the treatment of recurrent respiratory depression due to opioid overdose. The objective is to evaluate these treatments in reversing symptoms of opioid overdose. The study will also assess adverse events, including the development of precipitated opioid withdrawal, following the administration of each treatment. Nalmefene HCl injection is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids and in the management of known or suspected opioid overdose. Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.1 The Company distributes nalmefene HCl injection for no profit. The study will be independently developed and carried out by UNM’s research team with Purdue Pharma providing only funding and nalmefene HCI injection. Patient enrollment is planned to begin in July 2024. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose. CONTRAINDICATION Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product. WARNINGS AND PRECAUTIONS Use of Nalmefene Hydrochloride injection in Emergencies Nalmefene Hydrochloride injection, like all drugs in this class, is not the primary treatment for ventilatory failure. In most emergency settings, treatment with Nalmefene Hydrochloride injection should follow, not precede, the establishment of a patent airway, ventilatory assistance, administration of oxygen, and establishment of circulatory access. Risk of Recurrent Respiratory Depression Accidental overdose with long acting opioids [such as methadone and levo-alpha-acetylmethadol (LAAM)] may result in prolonged respiratory depression. Respiratory depression in both the postoperative and overdose setting may be complex and involve the effects of anesthetic agents, neuromuscular blockers, and other drugs. While Nalmefene Hydrochloride injection has a longer duration of action than naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Nalmefene Hydrochloride injection treatment. Patients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression. Cardiovascular Risks with Narcotic Antagonists Pulmonary edema, cardiovascular instability, hypotension, hypertension, ventricular tachycardia, and ventricular fibrillation have been reported in connection with opioid reversal in both postoperative and emergency department settings. In many cases, these effects appear to be the result of abrupt reversal of opioid effects. Although Nalmefene Hydrochloride injection has been used safely in patients with pre-existing cardiac disease, all drugs of this class should be used with caution in patients at high cardiovascular risk or who have received potentially cardiotoxic drugs. Risk of Precipitated Withdrawal Nalmefene Hydrochloride injection, like other opioid antagonists, is known to produce acute withdrawal symptoms and, therefore, should be used with extreme caution in patients with known physical dependence on opioids or following surgery involving high doses of opioids. Imprudent use or excessive doses of opioid antagonists in the postoperative setting has been associated with hypertension, tachycardia, and excessive mortality in patients at high risk for cardiovascular complications. Incomplete Reversal of Buprenorphine Preclinical studies have shown that nalmefene at doses up to 10 mg/kg (437 times the maximum recommended human dose) produced incomplete reversal of buprenorphine-induced analgesia in animal models. This appears to be a consequence of a high affinity and slow displacement of buprenorphine from the opioid receptors. Hence, Nalmefene Hydrochloride injection may not completely reverse buprenorphine-induced respiratory depression. Use in Pediatric Patients Safety and effectiveness of nalmefene hydrochloride injection in pediatric patients have not been established. ADVERSE REACTIONS The most common adverse reactions (>1%) reported in clinical trials with nalmefene injection were nausea (18%), vomiting (9%), tachycardia (5%), hypertension (5%), postoperative pain (4%), fever (3%), and dizziness (3%). To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or . Please read Prescribing Information available here. For more information, visit . About Purdue Pharma L.P. Purdue Pharma and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. Purdue’s plan of reorganization will deliver billions in value to communities across the country to fund programs specifically for abatement of the opioid crisis. The bankruptcy settlement will also deliver funds to private abatement trusts for the benefit of personal injury claimants. Substantially all of Purdue’s assets will be transferred to a new post-emergence company with a public-minded mission. This new company will be governed by new independent board members and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis. The company will continue serving patients who rely on its medicines, pursuing its pipeline and introducing medicines that will help save and improve lives. For more information, visit . About The University of New Mexico Research As an R1 university, The University of New Mexico serves as the state’s premier institution of higher learning and provider of health care by promoting discovery, generating intellectual and cultural contributions, and honoring academic values. As the only academic health center in New Mexico, UNM Health and Health Sciences is dedicated to pushing forward into uncharted research territory. Faculty, staff, and trainees work tirelessly to address New Mexico’s pressing health needs. At any given time, UNM Health and Health Sciences manages over 300 clinical trials and 900 major research projects. UNM’s influence continues to grow through innovative medical research that reaches every corner of the globe. References: Nalmefene Hydrochloride Injection 2mg/2mL (1mg/1mL) [Full Prescribing Information]. Stamford, CT: Purdue Pharma L.P., 02/08/2022. Accessed Feb. 8, 2024 MR-08522

Pennsylvania saw nearly 15 drug-related overdose deaths a day in recent years Half a million Medicaid recipients diagnosed with opioid use disorder do not receive medication-assisted treatment Collaboration with Ophelia provides Highmark Wholecare Medicaid and Dual Special Needs members access to life-saving medication-assisted treatment via telehealth NEW YORK, March 20, 2024 /PRNewswire/ -- Ophelia, an opioid addiction care provider, today announced a collaboration with Highmark Wholecare to provide access to high-quality, safe opioid use disorder (OUD) care services via telehealth to Highmark Wholecare's Medicaid and Dual Special Needs Plan (D-SNP) – individuals with both Medicaid and Medicare insurance – members. Ophelia has been part of Highmark Wholecare parent company Highmark Health's network in Pennsylvania since July 2021, serving 2.9 million commercial members. The new relationship offers Highmark Wholecare's 320,000 Medicaid and 40,000 D-SNP members in-network coverage for medication-assisted treatment (MAT), an evidence-based approach to OUD care that's considered the gold standard by the Centers for Disease Control and Prevention (CDC). In 2021, Pennsylvania experienced nearly 15 drug-related overdose deaths every day – twice the national average. According to the CDC, synthetic opioids (including fentanyl), which are increasingly found in counterfeit pills, were some of the primary drivers of the increase in overdose deaths in the past several years. Yet 32% of insured Pennsylvanians reside in a zip code with no publicly listed provider who can prescribe life-saving buprenorphine, a medication approved by the Food and Drug Administration to treat opioid use disorder. In addition to treatment deserts and localized provider shortages, people with OUD tend to experience financial hurdles when seeking treatment. Many treatment options do not accept commercial health insurance or Medicaid and have expensive out-of-pocket costs. The U.S. Department of Health and Human Services recently released a report that found half a million Medicaid recipients diagnosed with OUD do not receive medication. Access and financial and social barriers can force people with OUD to seek buprenorphine from illegitimate channels or continue their opioid use risking overdose and death. "Pennsylvania has been working to address the opioid crisis for years, with far too many barriers standing in the way of people seeking and receiving life-saving treatment," said Ellen Duffield, president and CEO, Highmark Wholecare. "Highmark Wholecare's collaboration with Ophelia is helping course correct this crisis by providing access to comprehensive OUD care that our Medicaid and D-SNP members can receive quickly and safely." When people seek OUD treatment, they are often required to travel to a clinic to receive a prescription, which can be logistically and financially challenging to coordinate. With Ophelia, patients can connect from home with care coordinators who help schedule telehealth appointments with Ophelia clinicians who have extensive education and training in psychiatry and addiction medicine. The clinician works with the patient to prescribe the necessary medication and helps manage their prescriptions. Researchers have found that patients who initiated treatment with buprenorphine or methadone were 76% less likely to overdose within three months and 32% less likely to have an opioid-related ER visit. "Our expanded collaboration with Highmark Health through Highmark Wholecare members allows us to serve communities that continue to be severely impacted by the opioid epidemic," said Zack Gray, CEO and co-founder at Ophelia. "The more we can break down barriers to treatment, the faster we can provide effective medications and services to people living with OUD that can improve, even save, their lives." For more information, visit: . About Ophelia Ophelia is a digital provider of medication-assisted treatment (MAT) for opioid use disorder (OUD), committed to making evidence-based treatment universally accessible. Its mission is to remove barriers for the 80% of Americans with OUD who are unable to access care. At its core is the Ophelia Care Model, a team-based clinical model and software platform developed by leading experts in addiction medicine and psychiatry. Ophelia is licensed to provide care in 49 states and D.C. and is contracted with Medicaid, Medicare, and Commercial insurers covering 85 million American lives. About Highmark Wholecare We believe in caring for the whole person in all communities where the need is greatest. We see a future in which everyone has equal opportunity to achieve their best health. Through our leading Medicaid and Medicare programs, we are coordinating health care that goes beyond doctors and medicine that helps members achieve not just physical health, but also delivers whole person care. Our team members are helping to drive this new kind of health care for our 410,000 Medicaid and Medicare members in collaboration with a network of 29,000 primary care physicians, specialists, hospitals, and other ancillary providers. We are also committed to supporting our neighbors through our many community outreach and engagement programs. Media Contact [email protected] SOURCE Ophelia