FDA Accepts Application for Nonprescription Naloxone


A decision by the FDA is expected by April 28, 2023, and, if approved, Harm Reduction Therapeutics will launch RiVive in early 2024.

The FDA has accepted a new drug application (NDA) for nonprescription RiVive (intranasal naloxone) for the emergency treatment of opioid overdose and granted the application priority review. A decision by the FDA is expected by April 28, 2023.

Developed by the nonprofit company Harm Reduction Therapeutics, RiVive 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.

Michael Hufford, M.D.

Michael Hufford, M.D.

"When we formed Harm Reduction Therapeutics in 2017, we saw the urgent need to develop an OTC naloxone product, an action that no other company had pursued. Now, five years later and driven by our success in advancing RiVive toward FDA approval, the public health landscape is beginning to evolve, with OTC naloxone hopefully set to become a reality," Michael Hufford, M.D., co-founder and chief executive officer at Harm Reduction Therapeutics, said in a press release.

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.

HRT has entered into a commercial supply agreement with a contract manufacturer in anticipation of FDA approval and U.S. launch in early 2024.

Related:FDA Proposes Prescription-to-OTC Naloxone

Last month, the FDA issued an assessment that aims to encourage the development of certain over-the-counter (OTC) naloxone drug products. A Federal Register indicates that certain naloxone drug products — up to 4 mg nasal spray and up to 2 mg autoinjector for intramuscular or subcutaneous use — may be approvable as safe and effective for nonprescription use.

The FDA’s notice does not cover all naloxone products and says more data are needed on the safety and efficacy for nonprescription use of higher dose naloxone products and naloxone supplied in other presentations.

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.

Some insurance companies, such as UnitedHealthcare, have eliminated copays for emergency use medication, including naloxone.

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