Opiant Fast Tracked for Nasal Nalmefene, for Treatment of Opioid Overdose

 

• Fast Track Designation further underscores the potential for OPNT003 to represent a major advance in the treatment of opioid overdose as opioid overdose deaths surge1
  
  

• This designation enables early and frequent communication with the FDA, in addition to the potential for a rolling submission of NDA application2
  

Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a company advancing medicines to better treat addictions and drug overdose, today announced that the U.S. Food and Drug Administration (“FDA”) has granted fast track designation for OPNT003, nasal nalmefene, its investigational treatment for opioid overdose.

In July, the Company reported positive results from a confirmatory pharmacokinetic (“PK”) study comparing OPNT003 to intramuscular nalmefene injection3. The characteristics OPNT003 exhibited in this study, coupled with nalmefene’s five-fold higher affinity compared to naloxone4, demonstrate its promise as a potential new treatment. OPNT003 is currently being studied in an ongoing pharmacodynamic (“PD”) study comparing it to nasal naloxone5. Both PK and PD data will form the basis of a New Drug Application (“NDA”) submission using the 505(b)(2) regulatory pathway.

https://finance.yahoo.com/news/opiant-receives-fda-fast-track-200500779.html