Synergy Pharmaceuticals announced positive top-line results from the second of two Phase 3 clinical trials evaluating the efficacy and safety of plecanatide 3mg and 6mg treatment doses in adult patients with chronic idiopathic constipation (CIC).
Study results are based on data from the second randomized, 12-week, double-blind, placebo-controlled Phase 3 trial. Preliminary analysis of the data indicates that both plecanatide 3mg and 6mg doses met the study’s primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders compared to placebo during the 12-week treatment period (20.1% in 3mg and 20% in 6mg dose groups compared to 12.8% in placebo; p=0.004 for both doses). The durable overall responder endpoint is the current FDA endpoint required for US approval in CIC.
The company plans to file its first new drug application (NDA) with plecanatide in the CIC indication in January 2016.
For more information visit SynergyPharma.com.