Sucampo Pharmaceuticals presented new data from a third Phase III trial evaluating lubiprostone in the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic noncancer pain. Initial results from the study were reported in April.
The newly released data confirmed that compared with placebo, lubiprostone therapy reduced the median time to first spontaneous bowl movement (SBM) from 38.5 hours to 24.25 hours. In addition, significantly more lubiprostone-treated patients experienced improvements in a range of OBD symptoms over the 12-week period, including stool consistency, constipation severity, abdominal bloating, and discomfort.
Lubiprostone is a prostone-based chloride channel activator discovered by Sucampo and already approved as Amitiza for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Back in February Sucampo and Takeda, its U.S. and Canadian partner for lubiprostone, said they anticipated filing an sNDA for the OBD indication during the first half of 2012.
Amitiza was approved by FDA in 2006 for the chronic treatment of CIC in adults and in 2008 for chronic treatment of IBS-C in women aged 18 years and older. The drug generated net sales of $226.4 million in the U.S. in 2011. However, there is ongoing litigation between Sucampo and Takeda, as Sucampo believes its North American partner hasn’t been putting enough muscle into marketing Amitiza.
The drug is separately approved in Switzerland for the treatment of CIC. It is under regulatory review in Japan and the U.K. for the treatment of CIC, with approvals expected in both countries this year. Sucampo partnered with Abbott to develop and market lubiprostone for the treatment of CIC in Japan. The deal gives Abbott right of first refusal to any additional indications for which lubiprostone is developed in that country.