Nasal-Spray Millionaire: Indivior's Opvee Nasal Spray Gets FDA Green Light for Opioid Overdose Treatment

The FDA has approved Indivior PLC's INVVY Opvee (nalmefene) nasal spray for the emergency treatment of opioid overdose in adults and pediatric patients aged 12 years and older.

Indivior added the product to its kitty when it acquired Opiant Pharmaceuticals Inc for 20.00 per share in cash, plus contingent value rights of up to $8.00 per share. 

In March, the FDA approved Emergent BioSolutions Inc's EBS Narcan, 4 milligrams (mg) naloxone hydrochloride nasal spray for nonprescription use – the first naloxone product approved for use without a prescription. 

In a 68-healthy subject-PK study, peak plasma concentrations of one 2.7 mg Opvee nasal spray in one nostril were observed earlier than a single dose of nalmefene 1.0 mg administered as an intramuscular injection. 

In addition, the mean maximum concentration after Opvee administration was approximately 2.3-fold higher than that after intramuscular injection. 

In a PD study in 61 opioid-experienced, non-dependent subjects, the effect of 2.7 mg Opvee was assessed on remifentanil-induced respiratory depression.

Following Opvee administration, the time to onset of reversal of respiratory depression was observed between 2.5-5 minutes, and full recovery of the respiratory drive was noted between 5-15 minutes after Opvee administration. 

Opvee is expected to be in the market in Q4 of 2023.

Indivior believes the clinical profile of Opvee supports the potential for this treatment to deliver annual net revenue of $150 million to $250 million, with expected earnings accretion after the second full year of launch.