Consumers may soon have greater access to over-the-counter (OTC) treatments for opioid overdoses, following the FDA’s approval of the second naloxone hydrochloride nasal spray available without a prescription.
The agency last week greenlit the sale of a 3 milligram (mg) nasal spray called RiVive, which contains a dosage of the medication naloxone, which reverses the effects of opioids and can restore a patient’s breathing after an overdose.
The “approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Robert Califf said in a statement. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Nonprofit pharmaceutical company Harm Reduction Therapeutics (HRT), which produces the medication, said that “no company, entity, or individual will profit from sales of RiVive” and that it’s looking for more funding partners to make the price of the drug affordable. The drug will be available by early 2024 “to US harm reduction organizations and state governments” as a free or low-cost treatment to prevent opioid overdose deaths.
The FDA approved Emergent BioSolutions’s Narcan, the first prescription-strength naloxone nasal spray, for OTC use in March. Addiction specialists voiced concerns that the medication’s price—about $135 for a two-dose package depending on the retailer, according to GoodRx—would affect how widely it’s used.
Narcan’s manufacturer aims to cap the out-of-pocket costs for a pack of two 4 mg doses at less than $50 for public interest groups such as government agencies, nonprofits, and first responders, according to an April statement from Emergent.
RiVive’s price will depend on HRT’s funding partners and charitable donations, but the nonprofit drug manufacturer believes it can provide a two-dose package of the treatment for $36, or “what it costs us to make it,” HRT co-founder and CEO Michael Hufford told Healthcare Brew,
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“Ideally, HRT would like to be able to give RiVive away at no cost, but that relies solely on funding partners/charitable donations,” Hufford said.
HRT will receive $9 million in funding from Purdue Pharma as part of the latter’s bankruptcy settlement to support the “commercial readiness” of the OTC overdose antidote, according to a March statement from the pharmaceutical company, whose Sackler family owners are avoiding future lawsuits as part of a deal.
HRT will provide at least 200,000 doses of RiVive, or 10% of the annual amount planned, for free once the drug hits the market, according to its statement. The drug will be produced under an agreement with manufacturer Catalent Pharma Solutions at its facility in Morrisville, North Carolina.
Opioids contributed to more than 68,000 overdose deaths in 2020, according to the CDC. “Public health experts have noted that the recent increase in opioid use disorder and overdoses coincided with the Covid-19 pandemic, but research showing how much the pandemic directly contributed to the trend remains inconclusive,” according to a recent Healthcare Brew story.
Last Friday, the American Medical Association (AMA) urged other naloxone manufacturers to submit over-the-counter applications, saying “there is no medical or ethical reason for naloxone manufacturers to delay submitting these applications.”
“The FDA’s approval is an important step in saving lives. Next, it is imperative OTC naloxone is carried by retailers, grocers, and pharmacies and is stocked in a visible location on store shelves for quick access in an emergency situation, similar to other first aid items,” AMA Substance Use and Pain Care Task Force Chair Bobby Mukkamala said in a statement.
Amanda Eisenberg and Shannon Young contributed to this report.