The over-the-counter (OTC) nasal spray by Emergent Biosolutions to treat suspected opioid overdose will be subject to priority review by the US Food and Drug Administration (FDA).
Emergent Biosolutions has been trying to get approval from the US Food and Drug Administration (FDA) to let them sell Narcan, a nasal spray that is already approved to treat opioid overdose in the US, without a prescription. Narcan is on track to become the first over-the-counter drug based on naloxone because of its priority review status, and the US healthcare agency will make its decisions by March 29, 2023.
The news from Emergent Biosolutions comes just a few weeks after the US Food and Drug Administration (FDA) said that some forms of over-the-counter (OTC) naloxone may be effective and safe, opening the door to its widespread use.
In some states, access to naloxone is restricted by a number of legal regulations, and in others, the medication is not always readily available to patients who are at most risk of overdose. If Narcan is approved, it may also face competition from generic versions of the drug, which will put more pressure on the business’s margins.
As per government information, there were more than 100,000 drug-related overdose deaths in the US during 2021, which is 15 percent more than in 2020. Emergent Solutions claims that the data in the application to the US Food and Drug Administration (FDA) supports the use of the nasal spray in a safe and effective manner based on its usability.