The Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee voted 14–4 in favor of the benefit risk profile of the New Drug Application (NDA) for SER120 (desmopressin nasal spray; Allergan and Serenity). In addition, the Committee voted 17–1 regarding the evidence in favor of at least one of the doses being effective.
SER120 is a very low dose desmopressin formulation administered intranasally for the treatment of nocturia in adults who awaken two or more times per night to empty the bladder. It is a metered nasal spray of either 0.75 or 1.5mcg administered approximately 30 minutes prior to bedtime. It contains cyclopentadecanolide which facilitates rapid absorption through the nasal mucosa.
Desmopressin is a synthetic peptide analog of the human anti-diuretic hormone, vasopressin. A variety of desmopressin products have been FDA-approved to treat central diabetes insipidus, primary nocturnal enuresis, mild von Willebrand disease and mild hemophilia for decades.
To ensure the safe use of SER120, the manufacturer has also developed a REMS plan to address the possibility of hyponatremia which can occur with desmopressin use.
The FDA is not bound by the Committee’s recommendation, but takes its advice into consideration when reviewing investigational medicines. The FDA is expected to take action on the NDA for SER120 in the 4th quarter of 2016.
For more information visit FDA.gov.