Harm Reduction Launches Naloxone Nasal Spray

Harm Reduction Therapeutics has begun shipping its nonprescription RiVive (naloxone) 3.0 mg nasal spray for the emergency treatment of opioid overdose. The first shipment has gone to Remedy Alliance/For The People, a nonprofit distributor of free or low-cost naloxone. Remedy Alliance works with more than 200 harm reduction programs in 44 states and Washington, D.C.

Harm Reduction is donating 200,000 doses of RiVive, 10% of its projected initial annual product production, to Remedy Alliance for free distribution. Remedy Alliance has also purchased an additional 28,000 twin packs of RiVive.

Harm Reduction will be making RiVive more broadly available in 2024 at cost or at a low breakeven cost, the company said in a press release. RiVive’s initial selling price $36 for a twin pack. This price covers ingredients, nasal spray devices, vials, as well as production, packaging, testing, and transportation costs. Harm Reduction executives are committed to ensuring that no one affiliated will profit from sales of RiVive, including its unpaid volunteer board of directors and staff.The nonprofit company is seeking additional funding to reduce the cost of the product and to help sustain operations.

Overdose deaths have been rising since 1999. In 2022 alone, there more than 107,000 overdose deaths, mostly involving synthetic opioids such as fentanyl, according to the FDA.

Related: FDA Approves Second Over the Counter Naloxone Nasal Spray

RiVive was approved by the FDA in July 2023 based on data from a study that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product. The drug has been demonstrated to be safe and effective for use as directed in its labeling. The use of RiVive nasal spray in those who are dependent on opioids may result in severe opioid withdrawal, including shaking, sweating and nausea.

RiVive uses a standard unit dose system that can be used in an emergency situation to reverse the effects of known or suspected opioid overdose. Each RiVive nasal spray device contains one dose of naloxone. It is currently being produced under a commercial supply agreement with Catalent, a contract manufacturing company, at its facility in Morrisville, N.C.