Narcan maker says over-the-counter nasal spray fast-tracked by FDA

(The Hill) – Emergent BioSolutions Inc., the maker of narcotic overdose treatment Narcan, said on Tuesday that the Food and Drug Administration (FDA) has accepted its application to grant priority review of its overdose nasal spray as an over-the-counter (OTC) product.

“The application has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. The Prescription Drug User Fee Act goal date is March 29, 2023,” said the company.

Naloxone, sold under the brand name Narcan, is a drug administered to reverse the effects of a suspected opioid overdose. The drug can be administered nasally and through an autoinjector.

Narcan can be bought without a prescription at most pharmacies in all U.S. states and territories, but it is typically not available OTC. It is usually bought “behind the counter” (BTC), which means a person must speak to a pharmacy employee in order to get the drug.

In November, the FDA issued a notice encouraging naloxone makers to get in contact with the agency to start discussions on switching the drug from BTC to OTC.

“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,” said the FDA.

In most states, insurance providers are required to cover Narcan to some degree. However, cities and states also operate programs making the treatment available for free.

Emergent said in its announcement that its submission to the FDA had included human studies demonstrating the safety and efficacy of Narcan.

“We look forward to working with the FDA to advance our application under Priority Review designation and believe in the scientific evidence that supports the efficacy and safety of NARCAN Nasal Spray as an over-the-counter option for opioid overdose reversal,” Robert Kramer, president and CEO of Emergent Biosolutions, said.