The team of Astellas Pharma and Ironwood Pharmaceuticals ($IRWD) reported a second Phase III success with the U.S.-based company's drug for treating irritable bowel syndrome and constipation, according to a press release.
The Japan trial's favorable outcome was the same as that achieved earlier in China.
Ironwood has partnered with local companies to get its linaclotide guanylate cyclase-C agonist in 30 markets, including the United States. Astellas expects to apply for review and approval with Japan's Ministry of Health, Labor and Welfare next year.
Ironwood licensed the drug to Astellas in 2009.
Japan estimates 2.9% of its adult population with the problem in a country that lacks any other treatment for it, according to the release. The Japan trial determined patients had significant improvement in two ways. The primary group showed 34% improvement versus 18% of those with a placebo, the second group 35% versus 19%.
The test also concluded the drug improved conditions in specific patients, those with abdominal and constipation systems such as bloating and pain or discomfort. The drug did, however, cause diarrhea in 9.6% of such patients, 0.4% for the placebo recipients, but the companies said in a release those cases were mild or moderate in severity.
An August deal saw Ironwood agree to help promote the Allergan ($AGN) irritable bowel treatment Viberzi in the U.S. based on sales and referral targets.
- here's the release