FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose

May 1, 2021

The US Food and Drug Administration (FDA) has approved a higher dose of naloxone hydrochloride nasal spray to treat opioid overdose. The newly approved product delivers naloxone 8 mg into the nasal cavity. The FDA had previously approved naloxone 2 mg and 4 mg nasal spray products.

“Today’s action meets another critical need in combating opioid overdose,” said Patrizia Cavazzoni, MD, FDA Center for Drug Evaluation and Research, Rockville, Maryland. “Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”

Over the last several years, the FDA has taken a number of steps to improve the availability of naloxone products, including encouraging manufacturers to pursue approval of over-the-counter naloxone products; requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to the prescribing information; and extending the shelf life of naloxone nasal spray from 24 months to 36 months.
The use of naloxone in patients with opioid use disorder may result in opioid withdrawal characterised by body aches, diarrhoea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

This approval was granted through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. The application relied partly on the FDA’s finding of safety and effectiveness for naloxone hydrochloride to support approval of the higher dose. The applicant demonstrated that reliance on the FDA’s finding of safety and effectiveness for naloxone hydrochloride was scientifically justified and provided pharmacokinetic data specific to naloxone hydrochloride nasal spray 8 mg to establish the drug’s safety and efficacy for its approved use.

Reference: https://www.fda.gov/news-events/press-announcements/fda-approves-higher-...

SOURCE: US Food and Drug Administration