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New Opioid Reversal Nasal Spray Approved By FDA

Consider this one important step forward in combatting America’s opioid crisis. Last week a major milestone was achieved when the U.S. Food and Drug Administration (better known as the “FDA“) approved the first high-dose nasal spray for reversing opioid overdoses. Dubbed Kloxxado, it contains 8 milligrams of naloxone and may have a major impact in saving people from fatal ODs.

The Associated Press reported on the announcement in early Maysharing insights from Hikma Pharmaceuticals, the company behind the drug. As we’ve reported in the past, naloxone has been one of the only saving graces when it comes to reducing the amount of lives lost to opioid addictions. It has an incredibly high success rate of reversing overdoses, but has been called out as being difficult to implement.

Kloxxado hopes to solve for that, by taking away the injection elements that are part of the traditional naloxone experience. Naloxone needles can also be complex for family members and friends to use if an emergency were to arise. With the spray, however, just two pumps of the bottle can help achieve the same effect.

And though certain sprays are currently available, Kloxxado hopes to change the game with a much higher naloxone concentration. Currently, typical opioid reversal sprays contain 4 milligrams of the antidote (half as much as Kloxxado).

Dr. Patrice Harris, head of the American Medical Association’s opioid task force was quoted in the AP article. She felt very confident that this new drug will save many more lives.

“Communities are looking for tools to respond to the epidemic of drug overdoses, and the FDA action today adds a powerful one,” Dr. Harris explained. “The FDA is making sure the overdose-reversing drug is potent enough to counteract the increasingly lethal and illicitly manufactured fentanyl.”

Reps from the FDA were also quoted in the piece. Dr. Patrizia Cavazzoni, director of their Center for Drug Evaluation and Research division, was very excited about the progress and emphasized the confidence that her team has in the spray. She also added that there will be plenty of safety precautions in place with Kloxxado. For one, there is absolutely no danger in ingesting too much of the spray. And it is not harmful for people who did not suffer an opioid overdose.

As of right now, Kloxxado is expected to become widely available by the summer or fall. It will come in packages containing two spray bottles and prices will be announced in the very future. We, for one, are excited and confident about this progress.