The agency late last year began encouraging drug companies to apply to switch some forms of the drug away from prescription only, a move advocates have long pushed for as a way to increase access.
Naloxone is currently only available as a prescription, though all 50 states have found workarounds to make the drug available at the pharmacy without a prescription. Yet the people who need naloxone the most are also the least likely to go to a pharmacy and request it.
Enter Narcan nasal spray, the brand name of naloxone. When it's administered timely, usually within minutes of the first signs of an opioid overdose, it can counter the overdose effects.
According to FDA, prescription Narcan is currently the most commonly sold emergency treatment for opioid overdose in United States pharmacies. It was first approved in 2015 to treat known or suspected opioid overdoses for people of all ages, including newborns.
The advisory committee's central question is whether untrained consumers can use the product safely and effectively. After the committee votes on Wednesday, the FDA said it expects to make a decision on Narcan's approval at the end of March.
Manufacturer Emergent BioSolutions said it's waiting until there's FDA approval to start production of Narcan for the over-the-counter market, so it won't be available until late summer.
But there are only two companies that have been granted fast-track priority review to sell naloxone over the counter: Emergent and the nonprofit manufacturer Harm Reduction Therapeutics, which makes RiVive.
Both products are nasal sprays, which cost significantly more for harm reduction groups than an injection kit.
Emergent wouldn't discuss any pricing plans, saying it's premature to discuss details until after the FDA makes a decision. Currently, a two-pack of Narcan costs about $140, but with discounts the price is about $40 a dose.
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