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) (Uncredited)

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

The Food and Drug Administration approved Hikma Pharmaceuticalsā€™ Kloxxado, a spray containing 8 milligrams of naloxone ā€” double the highest dose currently available.

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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.

ā€œCommunities are looking for tools to respond to the epidemic of drug overdoses, and the FDA action today adds a powerful one,ā€ Dr. Patrice Harris, head of the American Medical Associationā€™s opioid task force, said in an email. ā€œThe FDA is making sure the overdose-reversing drug is potent enough to counteract the increasingly lethal and illicitly manufactured fentanyl.ā€

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

ā€œAddressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone,ā€ Dr. Patrizia Cavazzoni, director of the FDAā€™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.

The AMA has been pushing for naloxone to be available at no cost or for a low out-of-pocket cost, and for more pharmacies to stock it. Harris noted that a study found 1 in 5 pharmacies doesn't stock the life-saving drug.

Injections of naloxone, which quickly reverses opioidsā€™ effects, have been available since 1971. More recent naloxone nasal sprays, such as the well-known brand Narcan, contain up to 4 milligrams of the drug. The spray versions are easier than injections for untrained family and friends to use in an emergency.

Thereā€™s no danger in giving too much naloxone, or in giving it to someone who did not suffer an opioid overdose.

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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma


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