A nonprofit naloxone producer is celebrating its current market approval by gifting away 200,000 doses of its over-the-counter nasal spray.
Hurt Discount Therapeutics mentioned in a press release that it’s going to donate almost a quarter-million doses of its new product to the Treatment Alliance, a company dedicated to reasonably priced naloxone entry. The announcement comes on the heels of the Meals and Drug Administration’s approval of Hurt Discount Therapeutics’ product RiVive, a brand new nasal naloxone spray used to reverse opioid overdose.
The 200,000-dose donation represents roughly 10% of Hurt Discount Therapeutics’ anticipated annual manufacturing, the nonprofit mentioned.
“We based Hurt Discount Therapeutics with the singular mission to forestall opioid overdose deaths,” Michael Hufford, the group’s CEO, mentioned in a press release. “We’re devoted to creating free or low-cost over-the-counter naloxone nasal spray obtainable to the communities who want it most.”
RiVive is the second naloxone product to obtain clearance to be bought over-the-counter. The primary, Narcan, obtained FDA approval in March.
Naloxone is considered as a important part of the U.S. response to the opioid epidemic. However its excessive value has hindered public well being businesses and neighborhood teams’ efforts to purchase and distribute the treatment en masse.
The Biden administration has not too long ago made naloxone pricing a spotlight, convening a gathering of for-profit producers to debate making certain the treatment is financially accessible. That assembly, nevertheless, notably excluded each Treatment Alliance and Hurt Discount Therapeutics.
The assembly got here amid continued criticism that centered specifically on Narcan’s producer. The corporate, Emergent BioSolutions, has lengthy confronted criticism for the value of its nasal spray, which at the moment retails for wherever between $38 and $124 per two-pack, in line with the drug pricing web site GoodRx.com. Hufford has mentioned that Narcan’s excessive value partly impressed his founding the nonprofit, and its improvement of a largely similar product.
Different producers have additionally rushed to deliver naloxone merchandise to the market, together with mechanically advanced, high-dose variations that may value a whole bunch and even hundreds of {dollars}. A dose of generic, injectable naloxone, against this, can value only a few {dollars}.
RiVive will probably be bought for as a lot as 40% lower than Narcan, in line with a spokesperson, which means {that a} typical two-pack of the nonprofit’s nasal spray may go for as little as $30 in comparison with a typical Narcan value of $50.
The brand new nasal spray additionally is available in a 3-milligram dose — barely lower than Narcan’s 4 milligrams, and considerably smaller than the upper doses in costly, brand-name merchandise like Kloxxado or Zimhi, which include 8 milligrams and 5 milligrams of naloxone, respectively.
RiVive’s smaller dose permits extra flexibility for individuals trying to reverse an overdose, the corporate mentioned. Whereas it may be administered as many occasions as vital, research present massive naloxone doses should not essentially more practical at reversing overdoses. Smaller doses, in the meantime, will help keep away from the extreme withdrawal signs that many individuals expertise upon being revived from an overdose.
Rahul Gupta, the director of the White Home Workplace of Nationwide Drug Management Coverage, applauded RiVive’s approval final month, and inspired extra corporations to work to make naloxone reasonably priced.
“I applaud all corporations working to heed the President’s name to extend entry and affordability of those life-saving medicines, and we urge extra corporations to observe their lead,” he mentioned in a press release. “As we’re seeing overdose demise charges degree off after years of fast will increase, we should do every little thing we will to double down on our efforts to finish this epidemic. As we speak’s approval signifies that extra life-saving overdose reversal merchandise will probably be obtainable over-the-counter for shoppers, and extra competitors available in the market ought to drive down prices.”
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