The FDA announced that it has approved Harm Reduction Therapeutic’s NDA for RiVive naloxone nasal spray for the reversal of opioid overdose. Harm Reduction initiated a rolling NDA submission for RiVive in October 2022, and the agency accepted the NDA for priority review in December 2022. RiVive is approved for OTC sales; however, Harm Reduction’s web site says that the nasal spray will be sold mainly to state governments and other organizations, with availability beginning early next year.
In its announcement, the FDA emphasized its efforts to make naloxone nasal sprays more available to the public, including its approval of OTC switches for Narcan in March 2023 and for Padagis’ generic version of Narcan in July 2023.
Harm Reduction was founded in 2017 as a non-profit to develop the 3 mg naloxone nasal spray, the only product in its pipeline. Much of the funding for development of RiVive has come from OxyContin maker Purdue Pharma; that company will not receive any proceeds.
FDA Commissioner Robert M. Califf commented, “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health. The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”
Read the FDA press release.
