FDA Approves Second Nasal Spray To Combat Opioid Crisis

Introduction

RiVive, a 3 mg naloxone hydrochloride nasal spray, has been given the go-ahead by the U.S. Food and Drug Administration for over-the-counter (OTC), nonprescription use in the treatment of known or suspected opioid overdoses.

Increasing consumer access to naloxone without a prescription is made possible by the agency's approval of this second nonprescription naloxone product. The manufacturer will establish the nonprescription product's pricing and availability schedule.

In the United States, drug overdose continues to be a serious public health concern. Over 105,000 documented death overdoses occurred in the year ending in February 2023, most of which were caused by synthetic opioids, such as illegal fentanyl. The conventional therapy for opioid overdose is naloxone, a drug that quickly reverses the symptoms of an overdose.

The corporation is aware that naloxone is a potent tool to assist in fast reversing the effects of opioids after an overdose, according to the FDA Commissioner. He also stated that the company has naloxone readily accessible, particularly as an authorized over-the-counter medicine, which makes it a vital weapon for defending the public's health. The FDA welcomes makers of different naloxone medications to explore possible nonprescription development programs with the agency. The agency has historically prioritized access to naloxone products.

Data from research provided by the company indicated identical quantities of RiVive enter the bloodstream as an approved prescription naloxone product was used to support the approval of RiVive nasal spray for nonprescription usage. It has been proven that the medication is both safe and effective when used in accordance with its labeling. The maker also offered information demonstrating that patients may use the medication correctly and safely without a doctor's supervision.

When used by people who are dependent on opioids, RiVive nasal spray may cause severe opioid withdrawal, which includes body aches, diarrhea, high blood pressure, tachycardia, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, anxiety, restlessness, or irritability.

The FDA has taken a number of actions to simplify access to medications that reverse opioid overdoses, reduce unneeded opioid exposure, and stop the emergence of new opioid addiction cases. In an effort to decrease the likelihood of non-medical use, accidental exposure, and overdose, the agency approved the first non-prescription naloxone nasal spray product in March 2023 and the first generic non-prescription naloxone nasal spray product in July 2023. Over the past year, new efforts have been made to expand opioid disposal options.

The FDA remains committed to addressing all aspects of substance use, abuse, substance use disorders, overdose, and mortality in the U.S. through the FDA Overdose Prevention Framework. Priorities of the framework include advancing the development of evidence-based treatments for substance use disorders and safeguarding the public from unapproved, diverted, or counterfeit drugs that pose overdose risks. These priorities are achieved by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.

Harm Reduction Therapeutics is permitted by the FDA to sell RiVive without a prescription.

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