Harm Reduction Therapeutics announced that it has made an initial filing for a rolling review of its NDA for RiVive naloxone nasal spray, an OTC product for the treatment of opioid overdose. In August 2022, the company announced that it had received Fast Track designation for RiVive (HRT001) and had signed a commercial supply agreement. The company said that it is planning for potential approval of the NDA and a US launch in early 2024.
The naloxone nasal spray is the sole candidate for Harm Reduction, a non-profit company founded in 2017 with a mission to “Prevent opioid overdose deaths by making low price naloxone available to everyone.” OxyContin maker Purdue Pharma has provided funding for development of RiVive since 2018.
Harm Reduction Therapeutics CEO Michael Hufford said, “Our NDA for RiVive is supported by a robust nonclinical program and a pivotal Phase 1 relative bioavailability study demonstrating that RiVive produced a 3-fold higher systemic exposure with comparable early absorption to the reference naloxone product. Moreover, our human factors validation study demonstrated that laypeople were able to administer RiVive in a simulated emergency overdose situation supporting that it will be appropriately used as an OTC product by the vast majority of people who need to administer it to victims of opioid overdose in order to save lives.”
Read the Harm Reduction Therapeutics press release.
