Easy to use delivery technology could prevent opioid overdose deaths
The National Institute on Drug Abuse (NIDA) is pleased to announce that Adapt Pharma Limited, a partner of Lightlake Therapeutics Inc., has commenced 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 and Lightlake Therapeutics Inc., a biopharmaceutical company developing novel treatments for addiction, entered into a partnership in 2013 to apply new technology towards development of a potentially lifesaving intervention for opioid overdose.
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.
Read NIDA Director Dr. Nora Volkow’s blog post about naloxone. Learn about overdose death rates.
For more information, contact the NIDA press office at media@nida.nih.gov or 301-443-6245.