{"id":53057,"date":"2023-01-18T19:03:30","date_gmt":"2023-01-18T18:03:30","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-grants-priority-review-for-nalmefene-prefilled-syringe-for-the-treatment-of-known-or-suspected-opioid-overdose\/"},"modified":"2023-01-18T19:03:30","modified_gmt":"2023-01-18T18:03:30","slug":"fda-grants-priority-review-for-nalmefene-prefilled-syringe-for-the-treatment-of-known-or-suspected-opioid-overdose","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-grants-priority-review-for-nalmefene-prefilled-syringe-for-the-treatment-of-known-or-suspected-opioid-overdose\/","title":{"rendered":"FDA Grants Priority Review for Nalmefene Prefilled Syringe for the Treatment of Known or Suspected Opioid Overdose"},"content":{"rendered":"
\n

STAMFORD, Conn.–(BUSINESS WIRE)–Purdue Pharma L.P. (\u201cPurdue\u201d) announced that FDA has accepted and granted priority review to the company\u2019s Abbreviated New Drug Application (ANDA) for Nalmefene Hydrochloride (HCI) injection, 2 mg\/2 mL (1mg\/1mL) Prefilled Syringe.* Nalmefene 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. 1<\/sup>\n<\/p>\n

\nPriority review is often granted to new therapies that fulfill an unmet medical need. The company is investing in nalmefene development efforts to help address the growing and continuing crisis of opioid overdose deaths, including those due to fentanyl and other synthetic opioids.\n<\/p>\n

\nEarlier last year, Purdue received FDA approval<\/a> for a vial dosage form of injectable nalmefene. In addition, FDA previously granted Competitive Generic Therapy <\/a>designation for the prefilled syringe and the nalmefene hydrochloride injection vial.\n<\/p>\n

\nIf approved, the nalmefene prefilled syringe dosage form will be distributed at no profit and is intended for use by paramedics with advanced medical training, emergency department physicians, physician assistants, nurse practitioners, and nurses. Purdue\u2019s nalmefene injection vial is currently<\/a> being distributed for no profit.\n<\/p>\n

\n\u201cNalmefene is an important treatment option to help abate the opioid crisis, which is being fueled by the increasing prevalence of illicitly manufactured synthetic opioids,\u201d said Craig Landau, MD, CEO and President, Purdue Pharma. \u201cMultiple interventions are required. We are committed to supporting a multi-faceted approach to abating the opioid crisis and look forward to FDA\u2019s response to our second dosage form for nalmefene.\u201d\n<\/p>\n

\nBoth nalmefene vial and prefilled syringe are generic forms of a previously approved opioid antagonist. Purdue is also developing an autoinjector form of nalmefene for potential use in the community setting by people without medical training.*\n<\/p>\n

\nHealthcare professionals can learn more about injectable nalmefene at www.nalmefenehcl.com<\/a>.\n<\/p>\n

\n*This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that nalmefene prefilled syringe will successfully complete development or gain FDA approval.<\/i>\n<\/p>\n

\nIMPORTANT SAFETY INFORMATION<\/b>\n<\/p>\n

\nINDICATIONS AND USAGE
\n
<\/b>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.\n<\/p>\n

\nNalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.\n<\/p>\n

\nCONTRAINDICATION
\n
<\/b>Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.\n<\/p>\n

\nWARNINGS AND PRECAUTIONS<\/b>\n<\/p>\n

\nUse of Nalmefene Hydrochloride injection in Emergencies
\n
<\/b>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.\n<\/p>\n

\nRisk of Recurrent Respiratory Depression
\n
<\/b>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.\n<\/p>\n

\nPatients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression.\n<\/p>\n

\nCardiovascular Risks with Narcotic Antagonists
\n
<\/b>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.\n<\/p>\n

\nAlthough 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.\n<\/p>\n

\nRisk of Precipitated Withdrawal
\n
<\/b>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.\n<\/p>\n

\nIncomplete Reversal of Buprenorphine
\n
<\/b>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.\n<\/p>\n

\nUse in Pediatric Patients
\n
<\/b>Safety and effectiveness of nalmefene hydrochloride injection in pediatric patients have not been established.\n<\/p>\n

\nADVERSE REACTIONS
\n
<\/b>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%).\n<\/p>\n

\nTo report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov\/medwatch<\/a>.\n<\/p>\n

\nPlease read Prescribing Information available here<\/a>.\n<\/p>\n

\nFor more information, visit www.nalmefenehcl.com<\/a>.\n<\/p>\n

\nAbout Purdue Pharma L.P.
\n
<\/b>Purdue Pharma<\/a> and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers. If consummated, Purdue\u2019s 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 would also deliver funds to private abatement trusts for the benefit of personal injury claimants.\n<\/p>\n

\nSubstantially all of Purdue\u2019s assets would be transferred to a new post-emergence company with a public-minded mission. This new company would be governed by new independent board members, and would operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis. The company would continue serving patients and consumers who rely on its medicines and products, pursuing its pipeline, and introducing medicines that will help save and improve lives.\n<\/p>\n

\nFor more information, visit www.purduepharma.com<\/a>.\n<\/p>\n

    \n
  1. \nNalmefene Hydrochloride Injection 2mg\/2mL (1mg\/1mL) [Full Prescribing Information]. Stamford, CT: Purdue Pharma L.P., 02\/08\/2022. https:\/\/www.accessdata.fda.gov\/spl\/data\/d4bb0797-a4ed-4ed4-9904-604433eea4ff\/d4bb0797-a4ed-4ed4-9904-604433eea4ff.xml<\/a>. Accessed November 29, 2022.\n<\/li>\n<\/ol>\n

    \nMR-08202<\/i>\n<\/p>\n

    Contacts<\/b> <\/p>\n

    \nMedia:<\/b>
    news@pharma.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    STAMFORD, Conn.–(BUSINESS WIRE)–Purdue Pharma L.P. (\u201cPurdue\u201d) announced that FDA has accepted and granted priority review to the company\u2019s Abbreviated New Drug Application (ANDA) for Nalmefene Hydrochloride (HCI) injection, 2 mg\/2 mL (1mg\/1mL) Prefilled Syringe.* Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53057","6":"format-standard","7":"category-industry"},"yoast_head":"\nFDA Grants Priority Review for Nalmefene Prefilled Syringe for the Treatment of Known or Suspected Opioid Overdose - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/fda-grants-priority-review-for-nalmefene-prefilled-syringe-for-the-treatment-of-known-or-suspected-opioid-overdose\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Grants Priority Review for Nalmefene Prefilled Syringe for the Treatment of Known or Suspected Opioid Overdose - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"STAMFORD, Conn.–(BUSINESS WIRE)–Purdue Pharma L.P. 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