Harm Reduction Therapeutics Introduces RiVive™, Over-the-Counter Opioid Overdose Reversal Medication
July 28 (Reuters) - The U.S. Food and Drug Administration has approved the prescription-free sale of the second opioid overdose reversal drug, its manufacturer Harm Reduction Therapeutics said on Friday.
Harm Reduction Therapeutics to Receive Additional Funding for its Low-Cost Over-the-Counter Opioid Overdose Reversal Medication from Purdue Pharma
PITTSBURGH, Dec. 26, 2022 /PRNewswire/ -- Harm Reduction Therapeutics (HRT), Inc., a 501(c)(3) nonprofit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone nasal spray available to the public, today announced that the FDA has accepted its New Drug Application (NDA) for OTC RiVive (3.0 mg intranasal naloxone) for the emergency treatment of opioid overdose. The RiVive NDA was also granted Priority Review, heralding a long-awaited milestone after public health experts1 and the FDA2 called for naloxone to be made available OTC. Harm Reduction Therapeutics expects to hear from the FDA regarding the approval of RiVive by April 28, 2023.
PITTSBURGH, Oct. 11, 2022 /PRNewswire/ -- Harm Reduction Therapeutics (HRT), Inc., a 501(c)(3) nonprofit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone available to everyone, today announced the filing of the first module of its New Drug Application (NDA) for RiVive (3.0 mg intranasal naloxone), as an OTC emergency treatment for opioid overdose. The module was submitted to the U.S. Food and Drug Administration (FDA) in accordance with HRT's rolling review proposal accepted by the FDA after it granted Fast Track status to the application in July 2022.
Harm Reduction Therapeutics Signs Supply Agreement for Fast Tracked Naloxone
The pharma announced the newest development recently into tiny biotech Harm Reduction Therapeutics (HRT), a 501c3 non-profit founded in 2017. The company’s sole focus is on getting an OTC nasal spray for naloxone approved and available on the market over the counter at “substantially lower retail cost,” compared to other naloxone products on the market.
STAMFORD, Conn.--(BUSINESS WIRE)--Harm Reduction Therapeutics (HRT) will receive up to $11 million of additional financial support from Purdue Pharma L.P. to advance its development of a low-cost, over-the-counter (OTC) naloxone nasal spray in the United States. Naloxone is an opioid antagonist rescue medication used to reverse the effects of a life-threatening opioid overdose.