What happened
Shares of Emergent BioSolutions (EBS -1.51%) were soaring 11% higher as of 11:13 a.m. ET on Thursday. The big gain came after the Food and Drug Administration (FDA) approved the company's Narcan on Wednesday as an over-the-counter (OTC) treatment for opioid overdoses.
So what
It's understandable why the healthcare stock jumped after the FDA approval. The U.S. faces an opioid epidemic. On average, one person in the country dies every eight minutes from an opioid overdose. And the problem is worsening.
Emergent's Narcan has been available since 2016 as a prescription drug for opioid overdose. Since then, more than 44 million doses of the nasal spray have been distributed. The FDA approval for Narcan as an OTC product opens up a new market channel.
It's probably best not to be overly euphoric about the FDA approval, though. Emergent BioSolutions included the anticipated OTC decision in its full-year 2023 guidance, which projects only 2.5% year-over-year revenue growth at the midpoint of the range. The company expects that sales of Narcan will decrease by nearly 20% this year even with the FDA approval as an OTC product.
Now what
Narcan won't be available over the counter at pharmacies immediately. Emergent has to make some manufacturing changes to support the nasal spray's new nonprescription packaging and has to modify its supply chain somewhat.
However, the company expects the OTC version to be available in the U.S. by late summer 2023. In the meantime, the product will continue to be available via prescription through existing channels.
