Two companies this week announced developments in fast-track processes to gain federal approval for a nasal-spray formulation of the opioid overdose reversal medication naloxone.
Indivior, a Richmond, Va.-based pharmaceutical company, announced on July 29 that the Food and Drug Administration (FDA) has granted priority review to its New Drug Application (NDA) for a naloxone nasal spray. Priority review status is granted to medications that are seen as bringing about significant advances in treatment effectiveness or filling a therapeutic void.
According to a news release from Indivior, it now expects that the FDA will issue a decision on its overdose reversal formulation by late in the fourth quarter of this year. The formulation is designed to be usable with minimal training by first responders or others assisting an overdose victim.
On the same day as the Indivior announcement, London-based Lightlake Therapeutics, Inc., announced that its licensing partner has submitted to the FDA its NDA for a naloxone nasal spray. Lightlake and the National Institute on Drug Abuse (NIDA) in 2013 entered into a partnership to advance technology for the overdose reversal medication that is sold under the brand name Narcan. NIDA announced in June that the FDA had agreed to review portions of the Lightlake/Adapt Pharma Limited NDA on a rolling basis.