Pharmaceutical Business review

Lightlake partner Adapt Pharma submits NDA to FDA for Narcan nasal spray

Narcan Nasal Spray has been granted Fast Track Designation by the FDA. Narcan Nasal Spray was developed in collaboration with the National Institutes on Drug Abuse (NIDA).

There is a rapidly growing opioid overdose epidemic in communities across America. Centers for Disease Control and Prevention (CDC) data indicates that almost 24,500 lives were lost to opioid overdose in 2013 and 76% of these deaths occurred in a non-medical setting, most frequently at home.

Over two-thirds of these deaths were due to prescription opioids, a commonly prescribed class of pain medication.

The Narcan Nasal Spray has been developed in response to calls for new easy-to-use formulations of naloxone for use in the communities and homes where the majority of overdose related deaths occur.

"We’re very pleased to see such progress. Through collaborating with NIDA, Lightlake has dedicated a tremendous amount of effort into this treatment, and it is exciting to reach this significant milestone," stated Dr. Roger Crystal, M.D., CEO of Lightlake.

In December 2014, Lightlake announced a licensing deal with a subsidiary of Adapt. As per the terms of the deal, in exchange for licensing its opioid overdose reversal treatment, Lightlake could receive potential development and sales milestone payments of more than $55 million, plus up to double-digit royalties.