FDA fast-tracks review of overdose drug naloxone for use without prescription
Summary
- Nonprofit Harm Reduction Therapeutics plans to distribute doses cheaply and free
A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription.
Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.
HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at-cost, about $18 a dose. HRT said it plans to produce 2 million doses a year.
“Cost and access is what we’re focused on," said Michael R. Hufford, HRT’s chief executive officer and co-founder.
The nonprofit joins a group of manufacturers pursuing over-the-counter status for the drug to address a crush of deaths from bootleg versions of the powerful opioid fentanyl.
Emergent BioSolutions Inc., maker of the Narcan brand of naloxone nasal spray, said earlier this month that its application for over-the-counter status had received an expected approval date of March 29. The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance.
Pocket Naloxone Corp. is applying for a nasal-swab version of the drug it said would be cheaper than nasal-spray versions. The startup said earlier this month that it submitted results to the FDA showing that its drug works more quickly than prescription versions.
The FDA has encouraged drugmakers to apply for approval for over-the-counter versions of overdose-reversal medications. Dr. Hufford and John Pinney founded HRT five years ago after attending a session in which the FDA urged companies to make such applications.
Dr. Hufford received funding from now-bankrupt Purdue Pharma, the manufacturer of OxyContin and a target for billions of dollars in lawsuits stemming from its role in the opioid crisis.
HRT said it continues to receive funds from the proceeds of Purdue’s bankruptcy proceedings. HRT said Purdue won’t receive royalties from Rivive and doesn’t control where and how the product is marketed.
Other nonprofits are also working to lower drug prices. Civica Rx, a nonprofit founded in 2018, introduced a cancer drug this year with a recommended price of $171 a month versus more than $3,000 a month without discounts for an older version charged to patients on Medicare Part D. Medicines360, a women’s health group, developed a hormonal intrauterine birth-control device it said it sells to safety-net clinics for $100, about a 90% discount.
This story has been published from a wire agency feed without modifications to the text
