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FDA Approves Narcan Nasal Spray for Opioid Overdose Treatment
The FDA has approved the first-ever nasal spray emergency treatment for opioid overdose. Naloxone hydrochloride (Narcan Nasal Spray, Adapt Pharma Ltd.), a ready-to-use, needle-free device that requires no assembly or priming, delivers a 4-mg dose of naloxone in a single 0.1-mL nasal spray.
Naloxone has been used to treat opioid overdose for nearly 45 years but had previously been approved only in injectable forms.
Data from the Centers for Disease Control and Prevention indicate opioid overdoses led to about 23,500 deaths in the United States in 2013, a fourfold jump from 1999. A majority of these deaths occur in nonmedical settings, stressing the need for user-friendly treatments that can be administered without the help of a medical practitioner, Adapt Chief Executive Seamus Mulligan told Reuters. The treatment, which Adapt plans to launch by January, is expected to have wide coverage under health insurance with affordable copays, Mulligan added.
Ireland-based Adapt bought the development and commercialization rights to the product from London-based Lightlake Therapeutics Inc. in December 2014.
Group purchasers, such as law enforcement, firefighters, first responders, departments of health, local school districts, colleges and universities, and community-based organizations that order directly from Adapt Pharma are eligible for a discounted Public Interest Price of $37.50 per 4-mg device ($75 for a carton containing two 4-mg devices).
Source: Adapt Pharma, November 19, 2015.