FDA approves first nasal Nalmefene spray for opioid overdose
Published: May 23, 2023
By Tristan Manalac
The FDA has approved Indivior PLC’s nalmefene nasal spray, now to carry the brand name Opvee, for the emergency treatment of confirmed or suspected opioid overdose, the company announced Monday.
As per Opvee’s label, the emergency nasal spray is indicated for patients aged 12 years and older who show signs of respiratory and/or central nervous system depression following exposure to natural opioids or synthetic counterparts such as fentanyl. Opvee is not meant to replace emergency medical care.
The label also bears warnings and precautions against the risk of recurrent respiratory and central nervous system depression, severe opioid withdrawal and cardiovascular side effects.
Opvee was initially developed by California biotech Opiant Pharmaceuticals, which Indivior announced it would acquire in November 2022 for $145 million. The deal closed in March 2023. Indivior expects Opvee’s sales to range from $150 million to $200 million.
Indivior anticipates Opvee to be available in the U.S. in the fourth quarter of 2023.
Monday’s approval of Opvee will give first responders a quick-acting and durable rescue medication option “to combat the current opioid epidemic and save lives,” Jerome Adams, executive director of Health Equity Initiatives at Purdue University, said in a statement.
Opvee is Indivior’s nasal spray formulation for the opioid antagonist nalmefene, which works by blocking opioid receptors to completely or partially reverse the effects of overdose. Opiant submitted data from three studies to show that administering nalmefene nasally was both safe and effective.
The first, a confirmatory pharmacokinetic study with 68 health participants, showed that nasal nalmefene leads to faster absorption and higher plasma concentrations of the drug. A second pharmacokinetic study additionally demonstrated that even when given in multiple doses, Opvee was safe and well-tolerated.
Opiant’s third study was a head-to-head pharmacodynamic comparison between Opvee and Emergent BioSolutions’ nasal spray Narcan (naloxone HCl). The study not only confirmed the non-inferiority of Indivior’s spray, but also demonstrated that Opvee outperformed Narcan at reversing remifentanil-induced respiratory depression at five minutes.
Opvee is the first FDA-approved nalmefene hydrochloride nasal spray allowed for both healthcare and community use, according to the regulator’s news release.
The approval is also in line with the FDA’s Overdose Prevention Framework, which seeks to “encourage harm reduction by supporting the development of novel overdose products,” FDA Commissioner Robert Califf said in a statement.
As part of this initiative, the agency allowed Emergent’s Narcan nasal spray to be dispensed over the counter in March 2023, greatly improving access to the overdose medicine.