Allergan and Serenity Pharmaceuticals have announced that the US 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). The vote was followed by a discussion of the indication among committee members. SER120 is an investigational drug developed for the treatment of nocturia, a common yet often under-diagnosed urological disorder, in adults who awaken two or more times per night to empty the bladder. Additionally, the committee voted 17-1 that there is substantial evidence to conclude that at least one of the SER120 doses is effective.
"Allergan is committed to the development of innovative therapies that fill significant unmet medical needs," stated David Nicholson, Chief R&D Officer, Allergan. "Nocturia is a common and problematic medical condition for many male and female patients, which can lead to impairment in quality of life. We look forward to the outcome of the SER120 new drug application discussions with the FDA."
"Upon approval, SER-120 will be the first treatment for nocturia in the United States. The advisory committee's positive vote supports our belief in SER120 as a potential new treatment option for patients that have a history of more than two nocturic episodes per night.,"1,2,3 said Dr. Samuel Herschkowitz, Chief Executive Officer, Serenity. "We are encouraged by today's positive outcome and will continue to work with the FDA as the agency completes its review of the SER120 new drug application."
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 fourth quarter of 2016.