FDA Gives Pharma a Boost to Develop OTC Opioid Overdose Antidote

The Food and Drug Administration is trying to make it easier for drug companies to make nonprescription versions of opioid overdose antidote naloxone.

The agency has created sample consumer-friendly labels drugmakers can use when they apply for permission to sell over-the-counter naloxone as a nasal spray or auto-injector, FDA Commissioner Scott Gottlieb said in a statement Jan. 17. This is the first time the agency has created and tested a label for a drug consumers can purchase directly, he said.

Key Insights

• Emergent BioSolutions Inc. sells a prescription naloxone nasal spray known as Narcan. Opiant Pharmaceuticals Inc. developed the spray ...