Low-dose naloxone drug products, including certain nasal sprays and autoinjectors, could one day be sold without a prescription, according to an initial assessment by the US Food and Drug Administration. Though the agency says it needs more data, a final determination could allow naloxone makers to get their product to market with fewer barriers to access than prescription versions of the drug.
Naloxone is used to treat opioid overdoses; proponents of the drug argue it should be more widely available to prevent overdose deaths. On 15 November, FDA published a notice that outlines the agency’s thinking on the safety and efficacy of non-prescription over-the-counter low-dose naloxone.
Regulators said that certain naloxone products, including nasal sprays that deliver up to 4mg of the drug and intramuscular or subcutaneous autoinjectors that deliver up to 2mg of the drug, may be safe and effective enough to be marketed without the need for a prescription.
“This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone,” FDA cautioned…
