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news.Adapt Pharma has started the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a nasal spray formulation of naloxone, a drug developed to treat opioid overdose.
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Adapt has partnerd with biopharmaceutical firm Lightlake Therapeutics to develop treatments for opioid overdose.
In December, Lightlake has agreed to license its opioid overdose reversal treatment to a subsidiary of Adapt. In return, the company would receive potential development and sales milestone payments of over $55m, and royalties.
A rolling NDA allows the company to submit the completed portions of the NDA for FDA’s review.
The FDA has approved Naloxone in injectable formulations for the emergency treatment of known or suspected opioid overdose.
Currently, the company is collaborating with the US National Institute on Drug Abuse (NIDA) to develop a naloxone nasal spray.
The development program for naloxone nasal spray has also been granted the FDA Fast Track Designation.
Lightlake CEO Dr 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."