FDA approves the first generic for life-saving opioid overdose treatment naloxone that can be carried by untrained individuals

On average, opioids kill more than 130 Americans every day. An effective agent to halt or reverse the effects of an opioid overdose is naloxone, which is available as a nasal spray, an injection, or as an intravenous infusion, and works by temporarily preventing the opioids from attaching to opioid receptors in the brain. On Friday, the FDA approved the first generic version of naloxone nasal spray that can be used to reverse suspected overdose in the community setting, made by Israel’s Teva $TEVA.

The approval came one day after the National Institutes of Health unveiled a study — supported by a $350 million grant — engineered to cut overdose deaths by 40% over three years in selected hard hit communities by adopting evidence-based prevention, treatment and recovery mechanisms across primary care, behavioral health, justice and other settings, such as the distribution of naloxone to reverse overdose and linking individuals in the criminal justice system with treatment for opioid addiction. The study will serve as a litmus test for a potential national campaign.

The crisis of opioid abuse, misuse and addiction has inspired various US agencies to take steps to curb opioid use at the physician’s office and to prevent and treat addiction and overdose. But for those who are already dependent — often after being prescribed potent painkillers following routine surgery and end up scoring street opiates such as heroin for their next fix — the stigma of medication-assisted treatment persists. In 2018, the US Surgeon General released a public health advisory urging more Americans to carry naloxone.

Often carried by first responders, Narcan (a 2015-approved nasal spray version of naloxone hydrochloride) is made by Adapt Pharma, which was swallowed by Emergent Biosolutions $EBS last year in a deal worth up to $735 million. The drug — which generated sales of $41.7 million in the fourth quarter of 2018 — is available at a 40% discount to state and local governments and non-profit organizations.

Friday’s Narcan copycat approval marks the first generic naloxone nasal spray for use in a community setting by individuals without medical training — however, generic injectable naloxone products have been available for years for use in a health care setting, the FDA said.

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Skyhawk Therapeutics Waltham, MA
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