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Nasal-spray version of naloxone will receive rolling review for approval

June 15, 2015
by Gary A. Enos, Editor
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A nasal-spray formulation of the opioid overdose reversal medication naloxone is about to receive an ongoing review for approval by the Food and Drug Administration (FDA), the National Institute on Drug Abuse (NIDA) announced June 12.

A partner of biopharmaceutical company Lightlake Therapeutics, Inc., has begun a rolling submission of a New Drug Application (NDA) for the new technology for administration of naloxone, which is currently available only in injectable form. The application process will allow the FDA to review portions of the NDA on an ongoing basis.

A clinical trial conducted by the London-based Lightlake in 2013 found that the nasal spray appeared to enter the bloodstream at least as quickly as injected naloxone. NIDA and Lightlake entered into a partnership that year to advance new technology for the overdose reversal medication.