Harm Reduction Therapeutics Begins Shipping OTC Naloxone Nasal Spray
The nonprofit pharmaceutical company plans to begin fulfilling orders for RiVive more broadly in early 2023 and will make it available across the US for free of charge or at a low breakeven cost.
Harm Reduction Therapeutics has begun making shipments of its over-the-counter (OTC) 3 mg naloxone hydrochloride nasal spray (RiVive) for the emergency treatment of suspected opioid overdose, the nonprofit pharmaceutical company announced in a press release.1
The first shipment of the company’s product has been sent to Remedy Alliance/For The People, a nonprofit organization helping to ensure community harm reduction programs have access to affordable naloxone. Harm Reduction Therapeutics is donating 200,000 doses to the nonprofit, 10% of the company’s projected initial annual production, and Remedy Alliance has also made an additional purchase of 28,000 twin packs.
“Harm reduction programs were the original innovators of community-based naloxone distribution almost 30 years ago,” Eliza Wheeler, co-founder and director of Remedy Alliance/For the People, said in a release.1 “Harm Reduction Therapeutics’ product donation is a game changer: we will be able to provide an affordable OTC naloxone nasal spray in addition to generic injectable naloxone to the programs we work with, over 80% of which are inadequately funded or do not receive enough affordable naloxone from other sources.”
RiVive was approved by the FDA in July and was the second naloxone HCI nasal spray available for OTC use without a prescription. It uses an easy-to-use standard unit dose system for single administration and has a 3-fold higher systemic exposure with comparable early absorption to reference naloxone products. The approval was supported by a study that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product.2
Data from human factors validation work in simulated emergency overdose situations also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
“We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose,” FDA Commissioner Robert M. Califf, MD, said in a release at the time of RiVive’s approval.2 “Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health.”
Opioids are currently the main driver of drug overdose deaths in the country, with nearly 88% involving synthetic forms like fentanyl. Opioids were involved in over 80,000 overdose deaths in 2021 alone, 75.4% of all drug overdose deaths, according to the CDC.3 Naloxone, which rapidly reverses an overdose by binding to opioid receptors and blocking the effects of other opioids, is now considered the standard treatment for opioid overdose.
Harm Reduction Therapeutics said that it plans to begin fulfilling orders for RiVive more broadly early next year and will make it available across the US for free of charge or at a low breakeven cost. The initial selling price for RiVive is set at $36 per twin pack, which covers the price of hard costs, production, packaging, testing, and transportation costs.
