FDA Approves First Generic Nasal Spray Against Opioid Overdose

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FRIDAY, April 19, 2019 — The first generic naloxone nasal spray to treat opioid overdose has received approval from the U.S. Food and Drug Administration.

Teva Pharmaceuticals' lifesaving product is also the first generic naloxone nasal spray approved for use by people without medical training. There is already a brand-name spray (Narcan) for emergency use by untrained people, such as family members and bystanders.

Douglas Throckmorton, M.D., the deputy center director for regulatory programs in the FDA Center for Drug Evaluation and Research, said in a news release that the agency is also helping drugmakers pursue approval of an over-the-counter naloxone product and "exploring other ways to increase availability of naloxone products intended for use in the community." In addition, the FDA is considering whether naloxone should be routinely prescribed along with all or some opioid prescriptions to reduce the risk for overdose. "All together, these efforts have the potential to put a vital tool for combating opioid overdose in the hands of those who need it most — friends and families of opioid users, as well as first responders and community-based organizations," Throckmorton said.

Opioid-dependent patients who receive naloxone may experience severe opioid withdrawal symptoms such as body aches, diarrhea, tachycardia, fever, nausea and vomiting, nervousness, irritability, abdominal cramps, weakness, and increased blood pressure.

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Posted: April 2019

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