Indivior PLC (LSE:INDV) announced that the US Food and Drug Administration (FDA) has approved its Opvee (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdoses induced by natural or synthetic opioids.
The ruling covers adults and pediatric patients aged 12 years and older.
Opvee is expected to be in the market in the fourth quarter with annual net revenue of $150mln to $250mln expected.
Indivior added Opvee to its portfolio with the acquisition of Opiant Pharmaceuticals which closed in March.
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.
Opvee was designed to address the challenges of what the firm called “today's opioid crisis.”
"Opvee's FDA approval represents a significant achievement in the development of new treatment options to address today's era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl," said Mark Crossley, Indivior CEO in a statement.