Published October 17, 2016
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 condition.
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. (http://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.