According to Harm Reduction Therapeutics, the FDA has accepted the company’s NDA for its RiVive naloxone nasal spray for the reversal of opioid overdose and granted the NDA Priority Review designation. Harm Reduction had announced the initiation of a rolling NDA submission for RiVive in October 2022. The company says that the FDA has set April 28, 2023 as the goal date for completion of its review.
OxyContin maker Purdue Pharma, which has been funding development of the naloxone nasal spray since 2018, provided an additional $11 million in March 2022. In August 2022, Harm Reduction said that it had signed a commercial supply agreement after the FDA granted Fast Track designation to the nasal spray.
Harm Reduction CEO Michael Hufford said, “When we formed Harm Reduction Therapeutics in 2017, we saw the urgent need to develop an OTC naloxone product, an action that no other company had pursued. Now, 5 years later and driven by our success in advancing RiVive toward FDA approval, the public health landscape is beginning to evolve, with OTC naloxone hopefully set to become a reality.”
Read the Harm Reduction Therapeutics press release.
