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# FDA Reviewers Question Trial Designs with Nocturia Drug
- URL: https://www.fdaweb.com/fda-reviewers-question-trial-designs-with-nocturia-drug/
- Published: 2016-10-17T12:00:00.000Z
- Updated: 2026-09-14T21:39:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137093

FDA reviewers are questioning clinical trial designs in a Serenity Pharmaceuticals NDA for SER120 (desmopressin nasal spray), which is proposed for treating adults with nocturia who awaken two or more times per night to urinate. The submission will be reviewed by the agency’s Bone, Reproductive and Urologic Drugs Advisory Committee 10/19.

In a briefing [document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM525329.pdf?ref=fdaweb.com) released in advance of the meeting, FDA reviewers say the Phase 3 trials had “extensive exclusion criteria, including diabetes insipidus, uncontrolled diabetes mellitus, congestive heart failure (New York Heart Association Class II-IV), polydipsia, uncontrolled hypertension, nephrotic syndrome, peripheral edema (>2+ pretibial edema on physical exam), history of urinary retention, neurogenic detrusor overactivity, obstructive sleep apnea, loop diuretics, glucocorticoids, and severe lower urinary tract symptoms due to benign prostatic hypertrophy, overactive bladder, or severe stress urinary incontinence.” In addition, the reviewers note that the trials did not systematically assess whether a reduction in urine output at night could have adverse effects on other aspects of the underlying condition(s). “For example, it is unclear whether daytime excretion of the retained nighttime water could exacerbate daytime frequency or urgency in patients with nocturia due to overactive bladder or benign prostatic hyperplasia.”

The reviewers also say that it is “uncertain whether a treatment that focuses on the symptom of nocturia, which is common to many conditions, could adversely impact timely diagnosis and management of the underlying condition. The applicant is proposing a broad, general indication for nocturia regardless of the underlying etiology. This is one area where we will be seeking advice from the advisory committee panel.”

On the safety side, the FDA review says hyponatremia is the most important safety concern with desmopressin. “Symptoms of hyponatremia include nausea, headache and lethargy,” the briefing document says. “Seizures, coma and death can also occur, particularly if the hyponatremia is severe and acute. The incidence of hyponatremia was numerically higher with desmopressin than placebo, and numerically higher withthe 1.5 mcg dose than with the0.75 mcg dose.”