FDA approves higher dosage of naloxone nasal spray to treat opioid overdose

May 3, 2021

The U.S. Food and Drug Administration (FDA) approved a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose.

The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products.

Naloxone is a medicine that can be administered by people with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option in the treatment of opioid overdoses.

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 FDA granted approval of KLOXXADO to Hikma Pharmaceuticals through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified.

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