Jan. 12, 2015
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.”
After reviewing the clinical trials from the first and second applications, the FDA concluded that compared to a placebo, the effect of Nocdurna in reducing nighttime urination “was modest and of unclear benefit.”
In trying to have the FDA reverse its decision, Ferring submitted a third application emphasizing data from the clinical trials demonstrating that Nocdurna improved quality of life measures and increased the amount of undisturbed sleep in patients.
However, an FDA reviewer commenting on the quality-of-life effects concluded that the evidence does not meet standards for listing such a benefit on the medication’s label. Additionally, a separate FDA reviewer assessing the possible sleep benefits of Nocdurna noted an absence of objective evidence to support such a claimed benefit.
Ferring proposed to mitigate the risk of low blood sodium levels by recommending that patients undergo monitoring of their sodium levels during the first week of use and at the one-month mark.
But that’s not sufficient because patients could develop dangerously low blood sodium levels after a month, Carome said. In fact, during one trial, a 78-year-old developed dangerously low blood sodium levels after using Nocdurna for nearly a year. The FDA noted that “there is still a persistent risk for hyponatremia which may become more apparent if the drug is used in a larger and more diverse population.”
“In the interest of protecting public health, Public Citizen urges the committee to recommend that the FDA reaffirm its prior decision and not approve Nocdurna,” said Carome.