OTC Switch For Naloxone Finding Interest Among Sponsors

With FDA 'si label comprehension study near completion, sponsors seem more positive about OTC versions of naloxone products. FDA has made clear it is interested in switching the product from Rx-only but had trouble generating sponsor desire to develop it.

Puzzle

FDA is recruiting sponsors of potential OTC naloxone applications and reports that interest is high, although concerns over pricing and the absence of physician-patient communication about using the product could be impediments to a switch.

Offering OTC naloxone is one proposed method of increasing access to the rescue medication for opioid overdoses, which could help...

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