Non-profit pharma company Harm Reduction Therapeutics (HRT) said that a Phase 1 clinical trial of its HRT001 naloxone nasal spray in healthy volunteers met its primary endpoint, demonstrating the bioequivalence of a 3.0 mg dose of HRT001 to a 0.4 mg dose of intramuscular naloxone at 2.5 and 5 minutes post dose. Funding for the study came from OxyContin manufacturer Purdue Pharma and was approved during that company’s bankruptcy hearings.
The unit dose naloxone nasal spray is HRT’s sole candidate. The anticipated trade name for the product if the nasal spray is approved, the company said, is “RiVive.”
HRT Chief Medical Officer Judy Ashworth commented, “The pharmacokinetic results from this trial were exactly what we were aiming for and represent a critical step for our plans to file a New Drug Application to the FDA for OTC naloxone.”
Co-Founder and Chair of the board of directors John Pinney said, “The need for a low-cost OTC naloxone product has never been greater. We could not sit by and watch as thousands die from lack of access to an affordable OTC naloxone product. We formed HRT as a nonprofit so that we could focus all our efforts on developing, manufacturing, and then commercializing an OTC naloxone nasal spray to provide the least expensive product possible to help save lives during the ongoing opioid epidemic. Our goal is to submit our NDA to the FDA later this year, with an estimated commercial launch by early 2024.”
Read the Harm Reduction Therapeutics press release.
