Nonprofit taps Catalent to help make dream of over-the-counter naloxone a reality

As the era of over-the-counter naloxone looms, nonprofit pharma company Harm Reduction Therapeutics is teaming up with a contract manufacturing juggernaut to make its dream of easily accessible overdose reversal drugs a reality. 

Harm Reduction has enlisted Catalent to help crank out commercial supplies of its prospective opioid antagonist RiVive. The move comes shortly after Harm Reduction won a priority review on its over-the-counter naloxone application at the FDA.

Despite all 50 states having access laws that permit pharmacists to dispense naloxone without a doctor’s prescription, all current versions of the drug—including Emergent BioSolutions’ nasal spray Narcan—are prescription products. The FDA is considering the OTC status for the drug to alleviate barriers to access.

Since 2017, Harm Reduction has been tinkering with a low-cost, non-prescription naloxone product it hopes could serve as a critical tool in the opioid overdose armamentarium. 

The company figures its product could score FDA approval in July 2023, which would tee up a U.S. launch in “early 2024,” Harm Reduction said in a press release.

Under the partnership, Catalent will manufacture the product at its 180,000-square-foot inhalation development facility in Morrisville, North Carolina.

As for rival Emergent, following receipt of a speedy review tag for OTC Narcan in early December, the company last month aced an FDA advisory committee meeting. The FDA is scheduled to make a decision on Narcan’s potential OTC pivot by March 29. 

Tackling the opioid crisis has been a key item on the federal health agenda in recent years. Last September, the Biden administration called for more than $1.5 billion in total federal funding to support substance use treatment and prevention.

The strategy also called for new FDA guidance meant to ease distribution of approved naloxone with a specific focus on boosting access in underserved communities.