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FDA Accepts New Drug Application for Naloxone Nasal Spray With Priority Review

Agency response expected at end of the year

The new drug application (NDA) for naloxone nasal spray (Indivior LLC) has been accepted and given a “priority review” designation by the FDA for the treatment of opioid overdose. The spray comes as a prefilled device containing naloxone that has been specially formulated for optimal absorption into the nasal mucosa. The device was designed to require minimal training so that individuals may be better-equipped to help an opioid overdose victim.

“Priority review” status accelerates the review time from 10 to 6 months from the day of NDA acceptance and is given to medications that may offer significant advances in treatment efficacy or that may provide a treatment where no adequate therapy exists. The FDA’s response to the NDA for naloxone nasal spray is expected late in the fourth quarter of 2015.

Naloxone nasal spray is expected to be the first FDA-approved intranasal naloxone product indicated to treat opioid overdose in the U.S.

Naloxone is an opioid receptor agonist that binds to opioid receptors in the brain to reverse the effects of natural and synthetic opioids. It is the standard treatment for an opioid overdose. Currently, only needle-based formulations of naloxone are FDA-approved.

In addition to creating the feeling of euphoria that drug users seek, opioids cause sedation and slowed breathing. When taken in large doses, opioids can cause breathing to stop, resulting in a fatal overdose. Prescription opioids cause more overdose deaths than all other drugs combined, including heroin and cocaine.

Source: PipelineReview; July 29, 2015.



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