The FDA announced that it encourages companies to develop nonprescription naloxone drugs to help reduce opioid overdoses.
Certain naloxone hydrochloride drug products may be “approvable as safe and effective for nonprescription use,” the agency explained in a draft Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use.
FDA has reached a preliminary opinion that the drug has the potential to be safe and effective when used in an unsupervised nonprescription setting at a dose of up 4 mg as a nasal spray and up to 2 mg when used in an intramuscular or subcutaneous autoinjector.
“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Dr. Robert M. Califf, in a news release. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for a…