FDA Approves Opioid Overdose Antidote Narcan for OTC Sale

FDA Approves Opioid Overdose Antidote Narcan for OTC Sale

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The Food and Drug Administration has found that certain naloxone products like Narcan are safe enough to possibly be sold without a prescription. Narcan, a brand name for naloxone, is a drug used to reverse the effects of opioids, usually in the event of an overdose.

“Today’s action supports our efforts to address the opioid overdose crisis by helping expand access to naloxone,” said the FDA commissioner Robert M. Califf when the FDA issued the notice.

According to the expertsit’s a move that would remove barriers to accessing life-saving drugs if they were administered in a timely manner.

What did the FDA say?

The agency said it strongly encourages naloxone manufacturers to contact the FDA as early as possible to initiate a discussion about a possible switch from prescription to over-the-counter drugs.

“Today, the U.S. Food and Drug Administration issued a Federal Register Notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, which may help facilitate the development and approval of certain nonprescription naloxone drug products, too by transitioning certain Naloxone drugs from prescription to non-prescription status,” the FDA said.

Two forms of the drug, a nasal spray and an auto-injector, could potentially be safe and effective for over-the-counter use. “We currently believe that naloxone nasal spray up to 4 milligrams (mg) and naloxone auto-injector for intramuscular (IM) or subcutaneous (SC) use up to 2 mg have the potential to be safe and effective to use as mandated in the labeling of non-prescription drugs without the supervision of a physician,” the FDA noted.

Naloxone is only available by prescription, although many states have found workarounds to make the drug more readily available. For example, people can request naloxone from a pharmacist via so-called standing orders, NBC News reported. Now people could buy it online or in store…

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