Indivior Receives FDA Approval for OPVEE (nalmefene)

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Indivior Receives FDA Approval for OPVEE (nalmefene)

Indivior’s OPVEE® (nalmefene) nasal spray has received FDA approval for the emergency treatment of opioid overdose in adults and pediatric patients aged 12 years and older. OPVEE contains nalmefene, an opioid receptor antagonist that rapidly reverses opioid-induced respiratory depression. Its fast onset and long duration make it well-suited to combat the challenges of the current opioid crisis. This approval marks an important milestone in addressing opioid overdose injuries and deaths.

“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, CEO, Indivior. “OPVEE is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, 2,3,4 and we are committed to making this novel rescue medication widely available to those who need it most to help save lives.”

OPVEE, the newly FDA-approved nasal spray, has undergone a groundbreaking pharmacodynamic study (NCT04828005). This study focused on 61 individuals with opioid experience but without dependence and assessed the effects of administering 2.7 mg of OPVEE on respiratory depression induced by remifentanil. The results are remarkable, with respiratory depression being reversed within 2.5 to 5 minutes of OPVEE administration, and complete recovery of respiratory function observed as early as 5 minutes. Furthermore, the duration of nalmefene’s action is comparable to that of major opioids like fentanyl. These findings position OPVEE as an invaluable solution for effectively combating the ongoing opioid overdose crisis.

“I have seen firsthand the devastating impact of the opioid crisis on college campuses and in emergency rooms,” said Madeline Hilliard, Founder, Team Awareness Combating Overdose (TACO) and DopaGE. “The FDA approval of OPVEE is good news for everyone impacted by the overdose crisis. In fact, it uses the same device as currently available nasal overdose reversal agents on the market.”OPVEE is set to hit the market in the fourth quarter of 2023. Indivior strategically acquired Opiant Pharmaceuticals solidifying its portfolio with the addition of OPVEE. This acquisition, completed on March 2, 2023, aligns with Indivior’s belief in the immense clinical potential of OPVEE. With an estimated annual net revenue range of $150 million to $250 million, Indivior anticipates substantial earnings growth from the Opiant acquisition within the second year of OPVEE’s launch. Get ready for the game-changing arrival of OPVEE in the fight against opioid overdose.

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