Oct 17 (Reuters) - 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. (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 Washington