Synergy Pharmaceuticals announced the submission of its first New Drug Application (NDA) to the Food and Drug Administration (FDA) for plecanatide for the treatment of chronic idiopathic constipation (CIC).
The NDA submission is supported by positive data from two randomized, double-blind, placebo-controlled Phase 3 clinical trials of plecanatide (3mg, 6mg) for CIC. The primary endpoint for both trials was the proportion of durable overall responders (%), defined as a patient who fulfills both ≥3 complete spontaneous bowel movements (CSBMs) per week plus an increase of ≥1 CSBM from baseline in the same week, for 9 out of the 12 treatment weeks. In addition, the same patient must be a weekly responder for at least 3 of the last 4 treatment weeks.
The first Phase 3 trial showed that both 3mg and 6mg doses of plecanatide demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders (21% in 3mg group, 19.5% in 6mg group) vs. placebo (10.2%) during the 12-week treatment period (P<0.001 for both doses). In the second Phase 3 trial, both doses also demonstrated statistical significance compared to placebo (20.1% in 3mg group, 20% in 6.0mg group vs. 12.8% in placebo; P=0.004 for both doses).
Plecanatide is a 16-amino acid peptide that is structurally identical to uroguanylin with improved stability and an 8-fold higher binding constant to the guanylate cyclase-C (GC-C) receptor. It exerts its activity primarily in the upper GI tract to facilitate fluid movement required for regular bowel function.
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