According to California-based start-up CounterAct, the FDA has approved of the company’s approach regarding potential approval of its naloxone nasal spray cap. The CounterAct cap is a plastic device that snaps onto the top of a prescription bottle. In the event of an opiate overdose, the top of the cap is removed, allowing a spray nozzle to fold out to deliver a dose of naloxone intranasally.
After meeting with the FDA, the company said, spray characteristics for the device have been specified, and a bioavailability study of the naloxone formulation and human factors studies will be required.
CounterAct Co-Founder Todd Pizitz said, “The results from this latest FDA Review was very encouraging and we are ready to begin the regulatory pathway,” said Dr. Pizitz.
Read the CounterAct press release.
