Health
FDA grants priority review to over-the-counter opioid overdose drugs
The FDA granted priority review to RiVive, an over-the-counter naloxone nasal spray. Photo courtesy of FDA/flicker
December 26 (UPI) — of Food and Drug Administration As the United States battles the opioid epidemic, it has granted nonprofit pharmaceutical companies priority review for over-the-counter opioid overdose treatments.
Harm Reduction Therapeutics Announces Priority Review Approval for RiVive 3 mg Naloxone Nasal Spray. statement On Monday, it said a decision on that application would be made by April 28.
Dr. Michael Hufford, co-founder and CEO of Harm Reduction Therapeutics, said:
“Today, five years later, with our success in advancing RiVive toward FDA approval, the public health landscape is beginning to evolve, and OTC naloxone is expected to become a reality.”
First approved by the FDA in 1971, naloxone is a safe and effective opioid antagonist and has been approved by the U.S. Centers for Disease Control and Prevention for suggest People who are at high risk of opioid overdose have it themselves. Most states say that naloxone can be purchased at local pharmacies without a prescription.
The FDA’s approval of RiVive has sought to make naloxone available over-the-counter as a way to combat opioid overdose deaths.
according to CDCThere were an estimated 107,622 drug overdose deaths in the United States last year, up nearly 15% from the previous year, according to the U.S. About 81,000 deaths from opioid-related overdoses were reported, an increase of about 10,000 from 2020.
In anticipation of FDA approval, Harm Reduction Therapeutics said it has signed a commercial supply agreement with the manufacturer, hoping to launch the drug in early 2024.
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