Astellas and Ironwood release positive Phase 3 results for constipation drug

pharmafile | January 30, 2017 | News story | Research and Development, Sales and Marketing Astellas, Ironwood, constipation 

Astellas Pharma, a Tokyo-based pharmaceutical, and Ironwood Pharmaceuticals, based in Cambridge, Massachusetts, have announced positive results from a Phase 3 trial into the use of linaclotide for patients with chronic constipation (CC).

The drug is already approved in many countries, including the US and Japan, for irritable bowel syndrome with constipation (IBS-C) and this latest data could see a further indication expansion. The trial continues with Japanese patients for a further 52 weeks while the drug has already met its primary endpoint.

“I am really pleased to receive the positive top-line results from the Phase III chronic constipation trial. If approved, Astellas expects linaclotide to provide a new therapeutic option for patients suffering from this condition, in addition to IBS-C, for which linaclotide has already obtained marketing approval in Japan,” said Bernhardt Zeiher, president of development at Astellas Group.

“Today’s positive Phase III results for linaclotide in chronic constipation mark the ninth Phase III/IIIb clinical trial in which linaclotide has met its primary endpoints, once again demonstrating consistent results in clinical trials across two indications, evaluating multiple doses and conducted in multiple countries,” said Mark Currie, chief scientific officer and president of Research and Development at Ironwood. “We look forward to working with Astellas to support the launch of linaclotide in Japan for adults with IBS-C and to advance it for CC.”

The Phase 3 trial included 186 adults with CC who received 500mcg of linaclotide or a placebo for 4 weeks. Though the endpoint and further details were not released, the companies released that patients showed “significant improvement” over those receiving a placebo.

Ben Hargreaves

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