FDA filings for Ironwood and Forest for linaclotide, and GSK and XenoPort for Horizant ER
US drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD) and Forest Laboratories (NYSE: FRX) have submitted a New Drug Application to the US Food and Drug Administration for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).
The submission includes efficacy and safety data from a Phase III program comprising four double-blind placebo-controlled trials and two open-label long term safety studies. A total of more than 2,800 patients received a once-daily dose of either linaclotide or placebo across the four placebo-controlled clinical trials: two trials in patients with IBS-C and two trials in patients with CC. In these trials, statistically significant improvements in abdominal and bowel symptoms were achieved for linaclotide-treated patients versus placebo-treated patients for all primary and secondary endpoints.
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