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OTC Naloxone's Potential Overshadowed As FDA Priortizes Rx Generic Reviews

 
• By Malcolm Spicer

FDA appears committed to stemming opioid abuse by accelerating reviews of ANDAs for generics of overdose treatments but acceleration for making one of them, naloxone, available OTC is needed, too, says Michael Hufford, Harm Reduction Therapeutics CEO. "Relief that ... FDA is demonstrating its willingness to do everything that it can to accelerate these approvals," but "frustration that the public continues to be denied access to low cost naloxone," he says.

The US Food and Drug Administration's prioritization of reviewing proposals for generics of Rx nalmefene and naloxone emergency opioid overdose treatments is both encouraging and frustrating to the researcher developing a proposal for an OTC naloxone nasal spray.

Michael Hufford, CEO of non-profit Harm Reduction Therapeutics Inc., tells HBW Insight that the FDA appears committed to stemming the spread of opioid addiction by accelerating reviews of abbreviated new drug applications for generics of Rx naloxone

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