Adapt Pharma rolls submision to NDA for naloxone-based nasal sprayJune 15, 2015
The National Institute on Drug Abuse (NIDA) has announced that Adapt Pharma Limited, a partner of Lightlake Therapeutics Inc., has started a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for a nasal spray formulation of naloxone, a drug designed to prevent opioid overdose deaths. A rolling submission allows completed portions of the NDA to be submitted and reviewed by the FDA on an ongoing basis.
NIDA said that it entered into a partnership with Lightlake Therapeutics Inc., a biopharmaceutical company developing novel treatments for addiction, in 2013 to apply new technology towards development of a potentially lifesaving intervention for opioid overdose.
According to NIDA, Naloxone can rapidly reverse opioid overdose. The only current FDA approved method of administering naloxone is by injection. An FDA-approved intranasal delivery system could widely expand its availability and use in preventing opioid overdose deaths, a public health problem of epidemic proportion in the U.S., NIDA said.