The US Food and Drug Administration (FDA) has approved the second opioid overdose reversal agent for over-the-counter (OTC) nonprescription use.
ReVive (Harm Reduction Therapeutics Inc) is a 3-mg naloxone hydrochloric nasal spray manufactured by Harm Reduction Therapeutics Inc, the first nonprofit pharmaceutical company to receive FDA approval of a naloxone nasal spray.
“Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” FDA Commissioner Robert M. Califf, MD, said in a statement. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”
FDA’s approval was based on data from a manufacturer’s study that found that the levels of RiVive that reached the bloodstream were similar to those of an approved prescription naloxone product.
“We are grateful that FDA granted RiVive approval so we can now achieve what most thought impossible and no other company has: broad delivery of a lower-cost nasal naloxone product without a prescription to save lives that could otherwise be lost to opioid overdose,” Michael Hufford, PhD, co-founder and chief executive officer of Harm Reduction Therapeutics, Inc, said in a statement.
The company, a 501(c)(3) organization, is funded by private donors and by contributions from Purdue Pharma. The contributions from Purdue Pharma have been approved by the bankruptcy court administering Purdue Pharma’s chapter 11 proceedings.
RiVive will be available in early 2024 primarily to harm reduction organizations and state governments in the US “for costs lower than other opioid antagonist nasal sprays,” according to the company’s statement. At least 200,000 doses will be made available for free.
Drug overdose deaths in the US have reached record highs in recent years, first surpassing 100,000 in 2021. The number continues to climb. The Centers for Disease Control and Prevention estimates that 109,680 Americans died from a drug overdose in 2022.
The FDA approved the first overdose reversal agent, Narcan (naloxone, Emergent BioSolutions), in March.
Kelli Whitlock Burton is a reporter for Medscape Medical News covering psychiatry and neurology.
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