FDA Accepts Filing of New Drug Application for Nalmefene Auto-injector for the Treatment of Known or Suspected Opioid Overdose
Purdue Pharma L.P. Awards Grant for Investigator-initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection
Indivior Announces Publication Demonstrating that OPVEE® (nalmefene)
As more than 100,000 Americans continue to die every year from the opioid overdose epidemic, the FDA late Monday approved another new nasal spray that can be used in emergency settings when there’s an opioid overdose for people ages 12 and older.
RICHMOND, Va., May 22, 2023 /PRNewswire/ -- Indivior PLC (LSE: INDV) today announced that the U.S. Food and Drug Administration (FDA) approved OPVEE® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.2 OPVEE contains nalmefene, an opioid receptor antagonist that provides fast onset and long duration reversal of opioid-induced respiratory depression, which is the primary cause of opioid overdose injury and death.2,3,4 OPVEE was designed to address the challenges of today's opioid crisis.
FDA Grants Priority Review for Nalmefene Prefilled Syringe for the Treatment of Known or Suspected Opioid Overdose
STAMFORD, Conn.--(BUSINESS WIRE)--Purdue Pharma L.P. announced today that Nalmefene Hydrochloride injection, 2mg/2mL (1mg/1mL) is now available in the U.S. for use by healthcare professionals. 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.
SANTA MONICA, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (Opiant) (NASDAQ: OPNT) today announced a capacity investment agreement with Aptar Pharma (Aptar), a leading provider of drug delivery systems, to expand production of Aptar’s nasal Unidose device, which will be used in the production of commercial supply of OPNT003, nasal nalmefene.
Study compared OPNT003, nasal nalmefene, with 4 mg nasal naloxone hydrochloride in reversing the respiratory depression produced by remifentanil, a synthetic opioidOPNT003 met the primary endpoint of...