US approves high-dose opioid reversal nasal spray from Hikma

This photo provided by Hikma Pharmaceuticals shows Kloxxado. U.S. regulators on Friday, April 30, 2021 approved the first high-dose nasal spray for reversing opioid overdoses. The Food and Drug Administration approved Hikma Pharmaceuticals Kloxxado, a spray containing 8 milligrams of naloxone  double the highest dose currently available. (Hikma Pharmaceuticals via AP)
This photo provided by Hikma Pharmaceuticals shows Kloxxado. U.S. regulators on Friday, April 30, 2021 approved the first high-dose nasal spray for reversing opioid overdoses. The Food and Drug Administration approved Hikma Pharmaceuticals Kloxxado, a spray containing 8 milligrams of naloxone double the highest dose currently available. (Hikma Pharmaceuticals via AP)

U.S. regulators on Friday approved the first high-dose nasal spray for reversing opioid overdoses.

The Food and Drug Administration approved Hikma Pharmaceuticals’ Kloxxado, a spray containing 8 milligrams of naloxone — double the highest dose currently available.

Experts and patient advocates say the more potent medicine is needed because low-dose naloxone sprays and injections sometimes must be given multiple times to keep someone alive until medical help arrives.

That's especially true because fentanyl, a powerful painkiller, has become involved in many U.S. overdose deaths. Drug overdose deaths, meanwhile, have reached all-time highs.

“Communities are looking for tools to respond to the epidemic of drug overdoses, and the FDA action today adds a powerful one,” Dr. Patrice Harris, head of the American Medical Association’s opioid task force, said in an email. “The FDA is making sure the overdose-reversing drug is potent enough to counteract the increasingly lethal and illicitly manufactured fentanyl.”

Naloxone is a prescription drug, but it's generally available nationwide without one through public health programs and at pharmacies.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

Kloxxado will be sold in packages containing two nasal spray devices. Hikma expects to launch it sometime later this year, and will disclose the price then, a company spokesman said in an email.