US FDA approves Opiant's spray for reversing opioid-related overdoses

[May 23, 2023]  (Reuters) - The U.S. Food and Drug Administration on Monday approved Opiant Pharmaceuticals Inc's nasal spray for reversing opioid-related overdoses, expanding treatment options in the country's fight against a crisis that has killed hundreds of thousands.

The approval of the spray for use in adults and children aged 12 years and older is expected to bolster addiction treatments of British drugmaker Indivior Plc, which recently acquired Opiant in a deal worth $145 million.

The spray, which will be sold under the brand name Opvee, is a nalmefene-based drug that acts more quickly and has longer-lasting effects when compared with naloxone, a commonly used medication for reversing opioid-related overdoses.

The drug will be available by prescription and is intended for use in health care and community settings, the agency said.

The approval comes nearly two months after the U.S. health regulator approved the prescription-free sale of Emergent Biosolutions' Narcan nasal spray, which is a naloxone-based drug used to reverse opioid overdoses.

Opiant is the original owner of Narcan and received a royalty payment from Emergent on sales of the product until late last year.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Opioid-related overdoses have claimed more than 100,000 lives in 2021, according to government estimates, prompting the Biden Administration to boost access to overdose reversal medications such as Narcan as it tries to deal with the epidemic.

Opiant's application to the health regulator included data from a study in which the drug produced a greater reversal of opioid-induced respiratory depression, compared with a similar dose of Narcan.

The intravenous form of the drug has been approved in the United States since 1995 for the treatment of opioid-related overdoses.

Indivior has said it believes the drug's sales will contribute to the company's profit after the second full year of its launch. Indivior plans to additionally list its shares on the Nasdaq in June.

(Reporting by Bhanvi Satija, Vaibhav Sadhamta and Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri and Anil D'Silva)

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