Emergent BioSolutions Inc., the maker of narcotic overdose treatment Narcan, said on Tuesday that the Food and Drug Administration (FDA) has accepted its application for priority review of its over-the-counter (OTC) nasal spray.
“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.
Narcan is a drug used to reverse the effects of opioid overdose. Narcan is the brand name for which naloxone is sold. It can be administered nasally and through an autoinjector.
Narcan can be purchased without a prescription at most pharmacies but is typically not available OTC. It is usually “behind-the-counter” (BTC), requiring an individual to speak to a sales associate or pharmacist to purchase the drug.
In November, the FDA encouraged naloxone makers to discuss creating an OTC variant.
“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 will cover most of the cost. Cities and states also have programs to make the treatment available for free.
Emergent said that its submission included human studies demonstrating safety and efficacy.
“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 G. Kramer, president and CEO of Emergent Biosolutions, said.
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