Nonprofit Company Begins Application Process for OTC Naloxone

The submission is expected to be complete by the end of the year, and if approved, could be available in early 2024.

Harm Reduction Therapeutics, nonprofit pharmaceutical company, has initiated a rolling submission for a new drug application (NDA) for RiVive (naloxone), as a nonprescription emergency treatment for opioid overdose. The first module has been submitted to the FDA, and the company expects the submission to be complete by the end of the year.

RiVive is an HRT001 is an intranasal formulation of naloxone (3.0 mg) delivered as an atomized spray (0.1 ml) using a standard unit dose system for single administration. If approved, the company anticipates a launch of early 2024.

The NDA for RiVive is supported by a nonclinical program and a pivotal phase 1 relative bioavailability study demonstrating that RiVive produced a three-fold higher systemic exposure with comparable early absorption to the reference naloxone product. The company was founded in 2017 to develop a low-cost, OTC naloxone product

“Moreover, our human factors validation study demonstrated that laypeople were able to administer RiVive in a simulated emergency overdose situation supporting that it will be appropriately used as an OTC product by the vast majority of people who need to administer it to victims of opioid overdose in order to save lives,” Michael Hufford, Ph.D., co-founder and chief executive officer at Harm Reduction Therapeutics, said in a press release

Related: Study: Costs of Naloxone a Barrier for Uninsured Patients

The Centers for Disease Control reported 100,000 American lives were lost in 2021 from drug overdoses and more than 80,000 lives were lost to opioid overdose in particular. Naloxone is able to reverse an overdose by blocking the effects of opioids within two to three minutes.

But the costs of naloxone grew substantially beginning in 2016, impacting the uninsured patient population, according to a study published in JAMA Health Forum. Conducted by the nonprofit RAND Corp., the study found that out-of-pocket costs increased by more than 500% for people who are uninsured. Uninsured Americans are a vulnerable population that represent about 20% of adults with an opioid-use disorder and nearly one-third of opioid overdose deaths.

The study also found that costs for insured patients have decreased. Some insurance companies, such as UnitedHealthcare, have eliminated copays for emergency use medication, including naloxone.