FDA Approves Higher-Dose Naloxone Product

The U.S. Food and Drug Administration has approved a higher dose naloxone nasal spray product. The new product, Kloxxado, delivers 8 mg of naloxone into the nasal cavity, which is double the 4 mg delivered in Narcan. A 2 mg formulation of naloxone is also on the market.

The move by FDA comes as CDC reported more than 87,000 deaths from opioid overdose in the 12-month period ending in September 2020, a record figure for a 1-year period.

“Today’s action meets another critical need in combatting opioid overdose,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “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.”

The approval of the new product is the latest in a series of moves by FDA to improve naloxone access. The administration has also:

• Encouraged manufacturers to pursue approval of over-the-counter naloxone products
• Required drug manufacturers for all opioid pain relievers and OUD treatment medications to add recommendations about naloxone to their prescribing information
• Extended the shelf life of naloxone nasal spray to 36 months, up from 24

The manufacturer of Kloxxado, London-based Hikma Pharmaceuticals, noted in a news release announcing the FDA approval of its product that according to a recent study of community organizations that had received distributions of 4 mg Narcan, 34% of attempted opioid overdose reversals required at least 2 doses, hence the pursuit of a higher-dosage naloxone product.

Hikma said in the release that it expects Kloxxado to be available in the latter half of 2021.