[{"orgOrder":0,"company":"Orexo","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive Results from Human PK Study Assessing Orexo's Intranasal Nalmefene Formulations for Opioid Overdose Reversal","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Aptar Pharma","sponsor":"Indivior","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Opiant Pharmaceuticals Partners with Aptar Pharma for Nasal Nalmefene Opioid Overdose Treatment","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 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Find Clinical Drug Pipeline Developments & Deals for Nalmefene
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 company intends to use the net proceeds for the advancement of its phase 2 trial evaluating, TH104 (nalmefene) for the treatment of moderate-to-severe cholestatic pruritis in primary biliary cholangitis.
Through the agreement, Hillstream aims to acquire a clinical stage asset, AV104 (nalmefene), an opioid antagonist, but first it intends to seek approval in an orphan disease for the treatment of moderate to severe cholestatic pruritis with primary biliary cholangitis.
Opvee (nalmefene) nasal spray is an opioid receptor antagonist approved by the Food and Drug Administration (FDA) to for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients.
Opvee (nalmefene) nasal spray is an opioid receptor antagonist approved by the Food and Drug Administration (FDA) to for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients.
The transaction strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets, notably OPNT003, a patented intranasal nalmefene formulation for opioid overdose treatment.
OPNT003 is a nasal formulation containing the high affinity opioid antagonist nalmefene. The NDA submission for OPNT003 is supported by results from a pharmacokinetic (PK) study comparing OPNT003 to an intramuscular nalmefene injection.
Nalmefene hydrochloride Injection, a generic opioid system modulator, indicated for the complete or partial reversal of opioid drug effects, including respiratory depression.
OPNT003, an intranasal formulation of nalmefene, a more potent, longer acting opioid antagonist that is especially well-suited to treat overdose caused by synthetics, is an investigational treatment for opioid overdose.
OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl.
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