Oct 17 The proposed dosing regimen for a
frequent nightly urination treatment, developed by Allergan Plc
and privately held Serenity Pharmaceuticals, has not
been adequately studied in clinical trials, a preliminary review
by the U.S. Food and Drug Administration staff concluded.
The drug, SER120, is a low-dose nasal version of the
commonly used treatment, desmopressin, and is designed to treat
adults with nocturia, a urological disorder characterized by
frequent urination at night.
There are no FDA-approved drugs to specifically treat the
Allergan has proposed starting patients with a 0.75
microgram (mcg) dose, and moving up to 1.5 mcg if necessary, but
this dosing regimen was not studied in any clinical trials,
staff reviewers said on Monday. (bit.ly/2dIxcrs)
In addition, late-stage data shows that only the higher dose
met the statistical criteria for efficacy.
Also, the "clinical meaningfulness" was unclear when
compared with a placebo, they said.
Nocturia, the awakening from sleep to pass urine two or more
times at night, is often an early indicator of systemic disease.
(Reporting by Natalie Grover in Bengaluru and Toni Clarke in