FDA removes a barrier to OTC naloxone development

To make it easier for drug manufacturers to develop over-the-counter naloxone, FDA released Thursday two model consumer-friendly Drug Facts labels that companies can use to gain OTC approval. This is the first time FDA has developed and tested a Drug Facts label to support development of an OTC product, FDA Commissioner Scott Gottlieb said in a statement.

Currently, all FDA-approved versions of naloxone, which when administered quickly can counteract effects of an opioid overdose, require a prescription. To market an OTC product, companies must develop a Drug Facts label and conduct studies to show that consumers can understand how to use the product without supervision of a health care professional. Gottlieb said some stakeholders have identified the requirement of those studies as a barrier to development of OTC naloxone...