FDA Approves RiVive, A Second OTC Opioid Overdose Reversal Drug
The drug, from Harm Reduction Therapeutics, is the first over-the-counter version of naloxone from a nonprofit company, which The Hill says may result in better availability of cheap or even free doses of the drug to those in need. Purdue Pharma's bankruptcy and more opioid items are also in the news.
Reuters:
US FDA Approves Second Over-The-Counter Opioid Overdose Reversal Drug
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. The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021. (7/28)
The Hill:
FDA Approves First Opioid Reversal Drug From A Nonprofit Company
The Food and Drug Administration on Friday approved the first version of over-the-counter (OTC) naloxone from a nonprofit company, a move that could bring cheap and even free doses of the opioid overdose drug to Americans who need it most. ... Each RiVive device contains one dose of naloxone. It will be exclusively available in twin packs containing two single-dose devices of 3 milligrams each. (Weixel, 7/28)
Also —
Reuters:
US Asks Supreme Court To Delay Purdue Pharma Bankruptcy Settlement
The U.S. Department of Justice on Friday asked the U.S. Supreme Court to stop Purdue Pharma from proceeding with a bankruptcy settlement that protects its Sackler family owners from lawsuits. An appeals court rejected a proposed delay earlier this week, ruling that Purdue may proceed with a bankruptcy plan that was approved in May. Purdue's bankruptcy plan would shield its owners from opioid lawsuits in exchange for a $6 billion contribution to the company's broader bankruptcy settlement. (Knauth, 7/28)
Axios:
A Possible New Way To Prevent Fentanyl Overdoses: Monoclonal Antibodies
The Food and Drug Administration on Thursday gave a North Carolina biotech company the go-ahead to test if a monoclonal antibody can prevent people from overdosing on fentanyl. The synthetic opiate is becoming a leading cause of death for people under 50. Naloxone is currently the most widely used drug to reverse an overdose, but researchers are looking at other treatments, including an experimental vaccine. (Moreno, 7/28)
AP:
Former Abortion Clinic Pleads With Residents To Keep 'Open Mind' About Syringe Service Program
West Virginia’s former abortion provider is pleading with capital-area residents to keep “an open mind and an open heart” about a proposal to add a syringe service program to its offerings in the opioid-ravaged state. “This work is too important and too vital to be guided by fear or disdain or past grudges,” Iris Sidikman, the harm reduction coordinator at the Women’s Health Center of West Virginia, said at a public hearing Thursday on Charleston’s west side. (Willingham, 7/28)
