Allergan Nasal Spray For Frequent Nighttime Urination Faces Review Hurdles
Advisory committee will weigh in on desmopressin as FDA questions broad indication and says clinical meaningfulness of treatment effects for Serenity Pharmaceuticals/Allergan’s product vs. placebo are unclear.
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Serenity's SER120 should be held to the same efficacy standards as Ferring's Nocdurna, which the agency has declined to approve three times, citizen petition says.
Desmopressin's limited efficacy over placebo doesn't dissuade FDA's advisory committee, which votes 14 to 4 in favor of approval even as many suggest indication be narrowed.
Advisory committee members recommend Ferring conduct new pre-approval study to demonstrate clinical meaningful benefit of nocturia treatment, offering up variety of possible study designs.