Serada is an extended-release, orally administered formulation of gabapentin for the treatment of menopausal hot flashes which uses the company’s Acuform drug delivery technology.
Breeze 3, a randomized, double-blind, placebo-controlled 24 week study comprised 600 women who were randomized into one of two treatment arms, one receiving either placebo or a total dose of 1800mg of Serada dosed at 600mg in the morning and 1200mg in the evening.
The co-primary efficacy endpoints showed reductions in the average daily frequency and severity of moderate-to-severe hot flashes, measured after four and 12 weeks of treatment.
Based on the data from this trial combined with the data from Breeze 1 and 2 Phase 3 trials, the company plans to review the results with the US FDA to file a new drug application (NDA).