FDA Allows Naloxone Spray in Higher Dose for Treating Opioid Overdose

The FDA has approved Hikma Pharmaceuticals’ higher-dose naloxone hydrochloride nasal spray to treat opioid overdose.

The newly approved generic product, Kloxxado, delivers 8 milligrams (mg) of naloxone, while the previously approved sprays delivered 2 mg and 4 mg.

Naloxone, also known as Narcan and Evzio, is designed to reverse opioid overdose within minutes and can be administered by people with or without medical training. It can rapidly restore normal respiration when breathing has slowed or stopped as a result of overdose.

The FDA has taken steps in recent years to make naloxone products more available, including encouraging manufacturers to develop over-the-counter naloxone products and extending the shelf life of naloxone nasal spray from 24 months to 36 months