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Naloxone Nasal Spray Submitted to FDA as Potential Treatment for Opioid Overdose

Company responds to need for more ‘user friendly’ formulation

A new drug application (NDA) has been submitted to the FDA for naloxone nasal spray (Narcan, Adapt Pharma), an investigational drug intended to treat opioid overdose.

The product was granted a “fast track” designation. Within 60 days of the submission date, the FDA will determine whether it will accept the application for review as filed. Naloxone nasal spray was developed in collaboration with the National Institutes on Drug Abuse (NIDA).

There is a growing opioid overdose epidemic in the U.S. Data from the Centers for Disease Control and Prevention (CDC) indicating that approximately 24,500 people died from opioid overdose in the U.S. in 2013 and that 76% of these deaths occurred in nonmedical settings, most often at home. More than two-thirds of these deaths were due to prescription opioids. Therefore, according to the product’s manufacturer, there is a need for a more “user friendly” formulation of naloxone suitable for use in the community.

While naloxone has been the standard opioid-overdose treatment for almost 45 years, all of the current FDA-approved formulations are injectable. A broad consensus, including the CDC, the American Medical Association, and the American Public Health Association, supports expanded distribution and availability of naloxone in community settings as a key element in addressing opioid-related deaths.

Source: Adapt Pharma; July 27, 2015.

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