Emergent BioSolutions Inc., the maker of Narcan, a nasal spray form of naloxone, said Tuesday it has fast-tracked an application filed by the U.S. Food and Drug Administration for an over-the-counter version of the widely used opioid-reversal nasal spray. .
The company said it had been working on the application for several months. According to Emergent, the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it in the front line for approval ahead of competitors who have already announced their planned forays into the market.
The FDA has encouraged pharmaceutical companies to apply for approval of over-the-counter versions of drugs such as Narcan to help combat the overdose crisis stemming from bootleg versions of the powerful opioid fentanyl.
Last week, FDA Commissioner Robert Califf said naloxone, which binds to opioid receptors to reverse the effects of opioids, should be as ubiquitous as defibrillators.
“Any application we receive is a priority. They will be reviewed as soon as possible, said Dr. Kaliff.
New would-be competitors and pressure from the FDA meant Emergent had to switch to over-the-counter. Any prescription-only naloxone product with no clinically meaningful difference from over-the-counter products is misbranded after the FDA gave prescription drug makers enough data to approve an over-the-counter naloxone product in November. said that it is considered
In its application for over-the-counter status, Emergent will not change the formulation of Narcan. The FDA only asked for emergency testing to see if people trying to use the product could understand the directions on the package and administer the drug without a prescription.
Robert Cramer, president and CEO of Emergent, said the company has not determined how much the over-the-counter drug will cost. According to GoodRx, the average cash price for a can of prescription-only Narcan was $152 in November, compared to about $137 for generic competitors on the market.
Two other companies looking into over-the-counter versions of naloxone may raise prices even further, saying they aim to lower prices to make it more widely available. Pocket Naloxone Corp. and Harm Reduction Therapeutics Inc., a nonprofit funded by now-bankrupt Purdue Pharma LP, both say they intend to make the drug affordable and widely available.
Mr. Kramer said the shift to over-the-counter pharmacy is a natural consequence of the evolution of the opioid epidemic. He said the company’s strategy is to invest in public-private partnerships that have the reputation and relationships to manage long-term health threats.
Last year, drug overdose deaths topped 108,000, killing people who unknowingly took opioids because of illegal fentanyl that was mixed with other drugs, including cocaine and counterfeit pills.
In April, a bipartisan group of lawmakers sent letters to seven major naloxone makers, including Emergent, urging them to apply for over-the-counter status.
“As the mental health and addiction crisis continues to plague our nation, this is a monumental step to expand more accessible treatment options for Americans who seek help,” said Rep. Brian Fitzpatrick (R-Pa.), a member of the group. Efforts and co-chaired the bipartisan Task Force on Addiction and Mental Health.
The recent entry of generic competitors into the $287 million opioid overdose reversal market has pressured Emergent’s stock, which is down 73% year-to-date. Naloxone provides about 24 percent of the company’s revenue, according to FactSet.
Sales of Narcan nasal spray are expected to reach $224 million in 2020, or 15 percent of naloxone sales in 2017, or 78 percent of $56 million, according to IQVIA Holdings Inc. These doses accounted for about 48% of naloxone kits in 2020, up from 21% in 2017.
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