The Food and Drug Administration (FDA), a US agency similar to Anvisa in Brazil, approved on Monday (22) the nasal spray by Opiant Pharmaceuticals to reverse opioid-related overdoses, expanding treatment options in the country that faces a crisis that has already killed hundreds of thousands of people.
Approval of the spray for use in adults and people aged 12 and over is expected to bolster addiction treatments for British drugmaker Indivior, 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 faster and has longer-lasting effects when compared to naloxone, a drug commonly used to reverse opioid-related overdoses.
The drug will be available by prescription and is intended for use in healthcare and community settings, the agency said.
The approval comes nearly two months after the US health regulator approved the over-the-counter 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 through the end of last year.
Source: CNN Brasil
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