FDA
panel backs Allergan's drug for frequent nightly
urination
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[October 20, 2016]
WASHINGTON (Reuters) - 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.
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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.
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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)
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