[{"orgOrder":0,"company":"Purdue Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Priority Review for Nalmefene HCI Injection","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Adlon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Supplemental New Drug Application for Adhansia XR\u00ae (methylphenidate HCl) Extended-Release Capsules CII","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Purdue Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Nalmefene HCl Injection, 2mg\/2mL (1mg\/1mL) for the Treatment of Known or Suspected Opioid Overdose with Natural or Synthetic Opioids","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Purdue Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Purdue Pharma L.P. to Provide Opportunities for Investigator-Initiated Research to Examine Opioid Overdose Reversal in Emergency Medicine Settings","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Purdue Pharma","sponsor":"Harm Reduction Therapeutics","pharmaFlowCategory":"D","amount":"$17.5 million","upfrontCash":"Undisclosed","newsHeadline":"Harm Reduction Therapeutics to Receive Additional Funding for the Development of its Over-the-Counter Opioid Overdose Reversal Medication from Purdue Pharma after Bankruptcy Court Approval","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Purdue Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Purdue Pharma Introduces Nalmefene HCl Injection, 2mg\/2mL (1mg\/1mL) in the U.S. for the Treatment of Known or Suspected Overdose with Natural or Synthetic Opioids","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Purdue Pharmaceuticals L.P","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Priority Review for Nalmefene Prefilled Syringe for the Treatment of Known or Suspected Opioid Overdose","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Purdue Pharma","sponsor":"Harm Reduction Therapeutics","pharmaFlowCategory":"D","amount":"$29.9 million","upfrontCash":"Undisclosed","newsHeadline":"Harm Reduction Therapeutics to Receive Additional Funding for its Low-Cost Over-the-Counter Opioid Overdose Reversal Medication from Purdue Pharma","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Purdue Pharma","sponsor":"Purdue Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Purdue Pharma L.P. Awards Grant for Investigator-initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Purdue Pharmaceuticals L.P","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Filing of New Drug Application for Nalmefene Auto-injector for the Treatment of Known or Suspected Opioid Overdose","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Purdue Pharma","sponsor":"MMCAP Infuse","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Purdue Pharma L.P. Enters Agreement to Provide Low-cost Opioid use Disorder Treatment to Correctional Facilities for Incarcerated Individuals","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"May 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Purdue Pharmaceuticals L.P
The agreement aims to provide buprenorphine and naloxone tablets CIII (generic Suboxone), a medication for opioid use disorder, at low cost to correctional facilities for incarcerated individuals with opioid use disorder.
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.
The grant will be used for the evaluation of nalmefene hydrochloride (HCl) injection, an opioid antagonist indicated for the complete or partial reversal of opioid drug effects.
The proceeds will be used to fund commercial readiness for HRT’s low-cost over-the-counter (OTC) intranasal naloxone spray, tradename RiVive. Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.
Nalmefene hydrochloride Injection, a generic opioid system modulator, indicated for the complete or partial reversal of opioid drug effects, including respiratory depression.
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.
The additional funding approved today will help HRT continue its work toward making OTC naloxone nasal spray available to the public. HRT plans to file a New Drug Application for naloxone nasal spray with FDA in 2022.
FDA recently approved ANDA for nalmefene hydrochloride Injection, an opioid antagonist indicated for reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in management of known or suspected opioid overdose.
FDA has approved ANDA for Nalmefene hydrochloride injection, an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, induced by either natural or synthetic opioids, and in management of known suspected opioid overdose.
The sNDA approval was based on data from a randomized, double-blind, parallel-group, placebo-controlled, Phase 3 Adult Laboratory Classroom (ALC) study evaluating the safety and efficacy of Adhansia XR in adult patients diagnosed with ADHD.