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FDA Panel Backs Nocturia Treatment
The FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) has voted 14 to 4 to recommend approval of an experimental drug to treat frequent nightly urination, or nocturia. The drug, SER120 (Allergan), is a nasal spray formulation of low-dose desmopressin.
Some reviewers described the drug’s efficacy as modest, and only at the highest dose studied (1.5 mcg), while others felt that indiscriminate use of the product could increase the potential for adverse effects, especially in the elderly. The majority of the panel decided, however, that the benefits of SER120 outweighed its risks.
Allergan is seeking FDA approval of SER120 for the treatment of nocturia in adults. The proposed starting dose would be 0.75 mcg (one nasal spray) 30 minutes before bedtime, which can be increased, if needed, to 1.5 mcg (two nasal sprays) nightly.
Desmopressin is a synthetic analog of vasopressin (antidiuretic hormone) that stimulates the reabsorption of water in the kidney, leading to more-concentrated urine and less water excretion. Several desmopressin formulations, including a nasal spray, are FDA-approved for the treatment of central diabetes insipidus, for the treatment of primary nocturnal enuresis in children, and for the maintenance of hemostasis in patients with von Willebrand’s disease and hemophilia A during surgery.
No FDA-approved drugs are indicated for the treatment of nocturia. Management of the disorder focuses on treating the suspected underlying cause––for example, management of volume overload in patients with congestive heart failure, and behavioral modifications, such as fluid restriction before bedtime. Desmopressin has been used off-label in some patients who do not respond to these measures.
Prior to the BRUDAC vote, FDA staff members issued a briefing document that painted an unflattering picture of SER120. The staff’s observations included the following:
- SER120 is proposed as a treatment for nocturia in adults who awaken two or more times per night to void without respect to nocturia etiology. The appropriateness of studying a treatment for nocturia (which is a symptom, not a disease) without regard to the underlying etiology is unclear.
- The proposed starting dose is 0.75 mcg per night, which may be increased to 1.5 mcg per night based on individual patient efficacy and tolerability. This proposed dosing regimen was not studied in any of the SER120 clinical trials.
- SER 0.75 mcg did not met the prespecified statistical criteria for efficacy in the treatment of nocturia.
- Allergan did not study the proposed dose-titration scheme of initiating treatment at 0.75 mcg and titrating, as needed, to 1.5 mcg. Instead, the company tested 0.75 mcg and 1.5 mcg in separate treatment arms.
- Allergan is seeking approval for adults regardless of age; however, efficacy in subjects younger than 50 years of age was not assessed.