Adapt Pharma has initiated a rolling NDA submission for intranasal naloxone for the treatment of opioid overdose, the company said. Adapt licensed the intranasal naloxone formulation from Lightlake Therapeutics in December 2014 and received Fast Track Designation for the product from the FDA in February 2015.
Lightlake CEO Roger Crystal said, “This is a very important milestone for Adapt and Lightlake. This submission reflects the progress that Adapt has made in advancing the development of this critical treatment. An ease-of-use, needle-free product is urgently needed to help address opioid overdose.”
Read the Adapt Pharma press release.
Read the Lightlake Therapeutics press release.