{"id":55275,"date":"2023-03-28T19:04:17","date_gmt":"2023-03-28T17:04:17","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/purdue-pharma-l-p-to-provide-funding-opportunities-for-investigator-initiated-research-to-examine-opioid-overdose-reversal-using-nalmefene-hcl-injection\/"},"modified":"2023-03-28T19:04:17","modified_gmt":"2023-03-28T17:04:17","slug":"purdue-pharma-l-p-to-provide-funding-opportunities-for-investigator-initiated-research-to-examine-opioid-overdose-reversal-using-nalmefene-hcl-injection","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/purdue-pharma-l-p-to-provide-funding-opportunities-for-investigator-initiated-research-to-examine-opioid-overdose-reversal-using-nalmefene-hcl-injection\/","title":{"rendered":"Purdue Pharma L.P. to Provide Funding Opportunities for Investigator-Initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection"},"content":{"rendered":"
\n

STAMFORD, Conn.–(BUSINESS WIRE)–Purdue Pharma L.P. is accepting proposals for investigator-initiated research (IIR) to examine the outcomes associated with the use of Nalmefene Hydrochloride injection, 2mg\/2mL (1mg\/1mL). Recognizing the value in obtaining data derived from sources other than traditional clinical trials, the Company will provide support for select investigations that explore outcomes associated with Nalmefene HCl injection in a real-world setting reflecting the current opioid overdose environment.\n<\/p>\n

\nNalmefene 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.1<\/sup> The Company distributes Nalmefene HCl injection for no profit.\n<\/p>\n

\n\u201cWe look forward to supporting continued exploration of real-world use of Nalmefene HCl injection through these research efforts,\u201d said Monica Kwarcinski, PharmD, Vice President, Medical Affairs at Purdue Pharma. \u201cThis IIR initiative seeks to support researchers pursuing studies to help advance our knowledge and understanding of opioid overdose reversal in real-world situations.\u201d\n<\/p>\n

\nResearch conducted under the initiative will be independently developed and implemented by independent investigators without the participation of the Company, with funding and\/or Nalmefene HCl injection provided by Purdue Pharma. Interested researchers must submit their Curriculum Vitae and a brief letter of intent outlining the study concept.\n<\/p>\n

\nLetters of intent will be accepted through April 30, 2023, at 5:00 p.m. ET. Additional information can be found on the Investigator-Initiated Research page<\/a> of the Purdue Pharma website.\n<\/p>\n

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

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

\nNalmefene 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<\/b>\n<\/p>\n

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

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

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

\nNalmefene 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<\/strong>\n<\/p>\n

\nAccidental 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.<\/strong>\n<\/p>\n

\nCardiovascular Risks with Narcotic Antagonists<\/strong>\n<\/p>\n

\nPulmonary 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<\/strong>\n<\/p>\n

\nNalmefene 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<\/strong>\n<\/p>\n

\nPreclinical 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<\/strong>\n<\/p>\n

\nSafety and effectiveness of nalmefene hydrochloride injection in pediatric patients have not been established.\n<\/p>\n

\nADVERSE<\/b> <\/strong>REACTIONS<\/b>\n<\/p>\n

\nThe 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.<\/b>\n<\/p>\n

\nPurdue 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

\nReferences<\/b>\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 March 7, 2023.\n<\/li>\n<\/ol>\n

    \nMR-08301<\/i>\n<\/p>\n

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

    \nMedia:<\/b>
    Michele Sharp
    \n
    (203) 588-7584\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    STAMFORD, Conn.–(BUSINESS WIRE)–Purdue Pharma L.P. is accepting proposals for investigator-initiated research (IIR) to examine the outcomes associated with the use of Nalmefene Hydrochloride injection, 2mg\/2mL (1mg\/1mL). Recognizing the value in obtaining data derived from sources other than traditional clinical trials, the Company will provide support for select investigations that explore outcomes associated with Nalmefene HCl … [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":["entry","post","publish","author-business","post-55275","format-standard","category-industry"],"yoast_head":"\nPurdue Pharma L.P. to Provide Funding Opportunities for Investigator-Initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection - 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\/purdue-pharma-l-p-to-provide-funding-opportunities-for-investigator-initiated-research-to-examine-opioid-overdose-reversal-using-nalmefene-hcl-injection\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Purdue Pharma L.P. to Provide Funding Opportunities for Investigator-Initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"STAMFORD, Conn.–(BUSINESS WIRE)–Purdue Pharma L.P. is accepting proposals for investigator-initiated research (IIR) to examine the outcomes associated with the use of Nalmefene Hydrochloride injection, 2mg\/2mL (1mg\/1mL). 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