FDA
2nd February 2015

FDA Panel Does Not Support Approval of Nocdurna

On January 12th, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the safety and efficacy of new drug.

FDA Panel Does Not Support Approval of Nocdurna

On January 12th, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the safety and efficacy of new drug application (NDA) 022517, proposed trade name NOCDURNA (established name: desmopressin), orally disintegrating sublingual tablets submitted by Ferring Pharmaceuticals, Inc. for the reduction of urine voiding in adults who awaken two or more times each night to void. 


EMDAC was given several discussion questions and one voting question. The committee voted 10 to 5, with two abstentions, that the drug’s benefit did not outweigh its risks. In addition to their vote, the committee was asked to provide their recommendation for additional studies (if they felt any were needed) and any recommendations they may have regarding how to identify the specific patient population whom may benefit from this particular drug.

Ferring argued that the reduction in voids found in their pivotal trial was meaningful both clinically and in terms of quality of life, but panelists felt the company had not provided direct evidence of a clinical benefit (i.e. objective measures of disturbed sleep, real outcomes such as fall or fracture).

“As it is right now, we have to make several leaps of faith to go from fewer nocturnal voids to better sleep, to better-rested, better-functioning patients,” said panelist Susan Heckbert, MD, PhD, professor of epidemiology at the University of Washington in Seattle. “We have to go even further to fewer falls and less mortality.”

Desmopressin, the active ingredient of Nocdurna, promotes reabsorption of water to reduce urine volume, and is currently approved as a generic drug for diabetes insipidus, hemophilia A, type 1 von Willebrand disease, and nocturnal enuresis in children. Generic desmopressin is sometimes prescribed off-label for this particular condition; however, there are no FDA-licensed treatments for nocturia in the U.S.

The FDA is not obligated to follow the advice of its panels, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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