US FDA accepts Ironwood and Forest's NDA for IBS drug linaclotide; new data from Almirall

US drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD) and Forest Laboratories (NYSE: FRX) said yesterday that the US Food and Drug Administration has accepted for review the New Drug Application for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). With a standard 10-month review timeline, the FDA Prescription Drug User Fee Act (PDUFA) target action date is expected to occur in June 2012.

The companies submitted the NDA for linaclotide for the treatment of IBS-C and CC based on efficacy and safety results 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 clinical trials: two trials in patients with IBS-C and two trials in patients with CC. Additionally, over 3,200 patients have enrolled in ongoing open-label safety trials and more than 2,000 of those patients have received linaclotide for at least 12 months.

Given that they gain FDA approval, Ironwood and Forest plan to co-promote linaclotide in the USA. Ironwood has out-licensed linaclotide to Spain’s Almirall for European development and commercialization, and to Japanese drug major Astellas Pharma for development and commercialization in Japan, Indonesia, Korea, the Philippines, Taiwan and Thailand.