Emergent BioSolutions Inc., the manufacturer of Narcan, a nasal spray formulation of naloxone, announced on Tuesday that U.S. The Food and Drug Administration expedited its application for an over-the-counter version of its widely used nasal spray to reverse the effects of opioids.
The company stated that it had spent several months developing the program. Emergent stated that the drug’s anticipated approval date is March 29, 2023 due to the FDA’s priority review, placing it ahead of competitors who have expressed their intentions to enter the market.
The FDA has pushed pharmaceutical companies to seek permission for over-the-counter versions of overdose-reversing drugs, such as Narcan, in order to combat the escalating overdose epidemic caused by counterfeit versions of the potent opioid fentanyl.
Last week, FDA Commissioner Robert Califf stated that naloxone, which binds to opioid receptors to counteract their effects, should be as widespread as defibrillators.
This is a high priority for all applications we receive. They will be examined as soon as possible,” Dr. Califf stated.
The nasal spray Narcan can be used to treat opioid overdoses.
Under pressure from potential new competitors and the FDA, Emergent was compelled to move to over-the-counter. The FDA informed prescription drug manufacturers in November that once it has sufficient data to support approval of a nonprescription naloxone product, any naloxone products marketed as prescription-only without a clinically significant difference from nonprescription products will be considered misbranded.
Emergent is not altering the formulation of Narcan in its application for the drug’s move to OTC classification. The FDA merely requested that Emergent evaluate whether those intending to use the medicine could comprehend packing instructions and self-administer the drug.
Robert Kramer, president and CEO of Emergent, stated that the company has not yet set the price of the over-the-counter medication. According to GoodRx, the average cash price for a box of prescription-only Narcan was $152 in November, compared to $137 for generic alternatives.
The city of New York distributes free Narcan nasal overdose spray on September 1, 2022 in Brooklyn, New York.
Two additional firms pursuing over-the-counter versions of naloxone are likely to exert additional pricing pressure, given their stated objective is to reduce prices to increase accessibility. Pocket Naloxone Corp. and Harm Reduction Therapeutics Inc., a non-profit funded by now-bankrupt Purdue Pharma LP, both state that they intend to make the medicine inexpensive and widely accessible.
According to Mr. Kramer, the shift to over-the-counter medications is a natural consequence of the emergence of the opioid pandemic. The company’s aim, according to him, is to invest in public-private partnerships that will gain it the reputation and relationships necessary to tackle long-term health hazards.
Last year, drug overdose deaths surpassed 108,000, spurred by illicit fentanyl, which is also present in cocaine and counterfeit medications, killing people who unintentionally swallowed opioids.
In April, a bipartisan group of politicians wrote to seven major naloxone producers, including Emergent, encouraging them to apply for OTC classification.
Rep. Brian Fitzpatrick (R-Pa.), a member of the group that led the effort and co-chair of the Bipartisan Addiction and Mental Health Task Force, stated, “As the mental health and addiction crisis continues to plague our nation, this is a monumental step forward for the expansion of more accessible treatments for Americans seeking help.”
Recent arrival of generic competition into the $287 million opioid overdose reversal market has put pressure on Emergent’s stock, which is down 73% year to date. According to data from FactSet, around 24% of the company’s revenue is generated by naloxone.
Narcan nasal spray sales increased from 15% or $56 million in 2017 to $224 million or 78% of naloxone sales in 2020, according to IQVIA Holdings Inc., which gathers drug sales data. In 2020, these doses comprised around 48% of naloxone kits, up from 21% in 2017.
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