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Treatment for Frequent Nighttime Urination Should Be Rejected, Public Citizen Tells FDA Advisory Committee

Agency Is Considering Nocdurna for the Third Time; It Provides Minimal Benefits, Carries the Risk of a Potentially Life-Threatening Condition

WASHINGTON, D.C. – The U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee should reject Nocdurna – designed to prevent frequent nighttime urination – because it provides few meaningful benefits and can cause a potentially life-threatening condition, Public Citizen said in testimony today.

After being rejected twice by the FDA, Ferring Pharmaceuticals is back before the agency a third time seeking approval for Nocdurna (whose generic name is desmopression). It is supposed to treat nocturnal polyuria, a condition that causes adults to awaken two or more times each night to urinate. But Ferring hasn’t provided any new data to show why the FDA should approve it this time. Nocdurna can cause dangerously low blood sodium levels.

“Getting out of bed to use the bathroom may be annoying, but it’s not worth risking your life to avoid,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “We hope the FDA will once again recognize that the risks of this medication strongly outweigh the benefits, and flush this application away.”