Emergent BioSolutions Inc., the developer of Narcan, a nasal spray form of naloxone, said that the US Food and Drug Administration has approved an application for an over-the-counter version of its popular opioid-reversal nasal spray.
The business stated that it has been working on the app for several months. According to Emergent, the FDA's priority review gives the medicine a projected approval date of March 29, 2023, putting it ahead of competitors that have indicated their plans to enter the market.
The FDA has pushed pharmaceutical firms to seek permission for over-the-counter versions of overdose-reversal drugs like Narcan in order to combat a growing overdose epidemic caused by fentanyl-laced heroin.
Last week, FDA Commissioner stated that naloxone, which binds to opioid receptors to counteract the effects of opioids, should be as widely available as defibrillators.
Emergent was forced to transition to over-the-counter because to pressure from new potential rivals and the FDA. The FDA informed prescription drugmakers in November that once it has sufficient data to support approval of a nonprescription naloxone product, any naloxone products marketed as prescription-only that do not differ clinically from non-prescription products will be considered misbranded.
Emergent is not modifying the formulation of Narcan in its application to transition to over-the-counter status. The FDA merely requested that Emergent examine whether anyone seeking to use the medicine could read the packing instructions and administer the drug without the assistance of a doctor.
Emergent's CEO stated that the company has not yet determined the price of the over-the-counter drug. According to GoodRx, the average cash price of a box of prescription-only Narcan in November was $152, compared to around $137 for generic competitors in the market.
Two additional businesses pursuing over-the-counter versions of naloxone are expected to push costs even down since they have said that their objective is to reduce pricing to allow for more access.
Pocket Naloxone Corp. and Harm Reduction Therapeutics Inc., a charity funded by the now-defunct Purdue Pharma LP, both claim to want to make the medicine affordable and widely available.
Last year, overdose deaths surpassed 108,000, fueled by illicit fentanyl, which is also making its way into other drugs, such as cocaine and counterfeit pills, killing people who unknowingly consumed opioids.
The recent introduction of generic competition into the $287 million opioid-overdose reversal market has weighed on Emergent's stock, which is down 73% year to date. Naloxone accounts for around 24% of the company's sales.
According to IQVIA Holdings Inc., which gathers medication sales data, sales of Narcan nasal spray increased to $224 million in 2020, or 78% of naloxone sales in monetary terms, up from 15% or $56 million in 2017. In 2020, these dosages accounted for around 48% of naloxone kits, up from 21% in 2017.
