WASHINGTON The benefits associated with Allergan Plc's experimental drug to treat frequent nightly urination outweigh the risks for certain patients, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday.
The panel voted 14-4 to recommend that the drug, SER120, be approved for certain patients with nocturia, defined as waking to urinate two or more times a night.
The FDA is not obliged to follow its advisory panel's recommendations, but typically does so.
SER120 is a low-dose nasal version of desmopressin, a drug used to treat a variety of conditions, including diabetes insipidus, a rare disorder that causes an imbalance of water in the body.
Allergan is seeking approval to market the drug for frequent nightly urination in general. The panel recommended the FDA approve it for a narrower population of patients whose nocturia is specifically caused by an increase in total urine volume, a condition known as nocturnal polyuria.
The panel made its recommendation based on a subset of patients in the clinical trial who seemed to fit the narrower criteria though the company's clinical trial was not specifically designed to test that population.
Some panelists described the drug's efficacy as modest, and only at the higher dose studied, 1.5 micrograms. They also expressed concern physicians may prescribe it indiscriminately, increasing the risk of side effects, especially in the elderly.
Desmopressin carries the risk of hyponatremia, or abnormally low sodium levels in the blood.
Allergan acquired exclusive rights to develop and sell the drug in 2010 from privately held Serenity Pharmaceuticals.
(Reporting by Toni Clarke in Washington; editing by Leslie Adler, G Crosse)