The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) has voted to recommend approval of Allergan’s SER120 desmopressin nasal spray for the treatment of nocturia (needing to wake up to urinate at night) in adults. The vote was 17-1 on the question of whether at least one of the SER120 doses is effective and 14-4 on the question of whether the benefits of SER120 outweigh the risks.
Allergan licensed the drug from Serenity Pharmaceuticals in 2010. The FDA is expected to complete its review of the NDA by the end of 2016.
Allergan Chief R&D Officer David Nicholson said, “Allergan is committed to the development of innovative therapies that fill significant unmet medical needs. 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.”
Serenity CEO Samuel Herschkowitz commented, “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. 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.”
Read the Allergan press release.
