The FDA granted a pharmaceutical nonprofit precedence evaluate to make an affordable, over-the-counter nasal spray that reverses opioid overdoses, the group reported Monday.
“RiVive,” the three milligram nasal spray made by Harm Reduction Therapeutics Inc., makes use of a naloxone formulation that may could be thrice stronger than the traditionally-used shot, the corporate stated.
Naloxone, generally recognized by the model title Narcan, is a drugs used to reverse or scale back the results of opioids.
According to the corporate, the FDA goal approval date is ready for April 28, the Wall Street Journal reported Monday. The FDA has not commented.
The information comes as opioid deaths — particularly these associated to the stronger and deadly opioid fentanyl — have remained staggeringly excessive throughout the nation.
The Massachusetts Department of Public Health lately reported 1,696 confirmed and estimated opioid-related overdose deaths within the first 9 months of 2022. Fentanyl was present in 94% of the state’s overdose deaths with accessible toxicology experiences.
Harm Reduction Therapeutics stated it plans to provide 2 million doses a yr and provides away considered one of each ten doses. The relaxation could be offered at-cost to pharmacies, public-sector workers and teams working with drug customers. The product is slated to price about $18 a dose.
The firm advertises the spray as a “groundbreaking” step ahead — shifting away from the present high-profit, prescription-required distribution of naloxone to a non-profit and publicly accessible mannequin.
“Every day 188 Americans die from an opioid overdose, while naloxone, the antidote that could potentially have reversed these overdoses, sits behind both cost and access barriers,” Harm Reduction Therapeutics writes on the drug web site.
The firm isn’t the one one dashing to get a brand new product on cabinets within the mild of the persevering with opioid epidemic.
The maker of the favored naloxone product Narcan, Emergent BioSolutions Inc., additionally reported their over-the-counter nasal spray is anticipated to obtain FDA approval by March 29. The firm’s at present accessible prescription-only naloxone nasal spray sells for over $100 with out insurance coverage.
A 3rd firm, Pocket Naloxone Corp. is growing a naloxone nasal swab and stated they reported optimistic testing outcomes to the FDA earlier within the month. The product, the corporate says, could be cheaper and work extra rapidly than at present accessible variations.
Source: www.bostonherald.com”