Harm Reduction Therapeutics, a 501(c)(3) non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths, signed a commercial supply agreement with Catalent for the manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive (3.0 mg), for the emergency treatment of known or suspected opioid overdose.
The commercial supply agreement comes after the U.S. FDA granted Harm Reduction Therapeutics Priority Review status on December 26, 2022, for its over-the-counter (OTC) naloxone nasal spray NDA. Naloxone is a safe and effective opioid antagonist, having originally been approved by the FDA in 1971 and has been used extensively to reverse opioid overdoses. Access to existing naloxone nasal sprays is currently limited to behind-the-counter pharmacy distribution through a prescriber or a Health Department’s standing order.
