The company’s supplemental new drug application is the first prescription to over the counter (OTC) switch to ever be granted priority review by the US Food and Drug Administration (FDA).
Emergent BioSolutions’ product is Narcan (naloxone HCI) nasal spray 4mg, which is approved for the treatment of known or suspected opioid overdose, but is currently available only as a prescription.
By applying for OTC use, the product would be significantly easier to access for those in need. Earlier this year, the FDA announced a request for comment on the possibility of approving certain types of naloxone products for nonprescription use.
The agency stated, “It is our preliminary opinion at this time that naloxone nasal spray up to 4 milligrams (mg), and naloxone autoinjector for intramuscular (IM) or subcutaneous (SC) use up to 2 mg, have the potential to be safe and effective for use as directed in nonprescription drug labeling without the supervision of a healthcare practitioner.”
As a result of the FDA’s review of the area, Emergent’s application to extend the indication of the product into OTC use was provided a priority review. The company indicated that an action date has been set for the FDA’s by March 29, 2023.
The reason the application is being treated as warranting faster review is the ongoing opioid epidemic, and the number of overdoses that are occurring in the US due to opioids and particularly synthetic opioids, such as fentanyl.
In its comments, the FDA stated that naloxone is a ‘critical tool’ to help reduce these deaths from opioid overdose. Emergent’s product offers the advantage of being delivered nasally, which is a simpler method of delivery compared to the injected form of naloxone.
The company’s product has been on the market since 2015, when it became the first intranasal formulation of naloxone to receive approval. Emergent outlined that it has more than five years of post-marketing data to provide to the FDA regarding the product’s safety and efficacy.
Numerous lawsuits are still ongoing to determine the healthcare industry’s role in the development of the opioid epidemic. In November 2022, CVS, Walgreens, and Walmart agreed to settle multi-billion dollars claims against them regarding their role in the development of the opioid epidemic.