Sucampo Pharmaceuticals, Inc., (Sucampo Pharmaceuticals) today announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C).
Lubiprostone, developed by Sucampo Pharmaceuticals, is currently approved for the treatment of Chronic Idiopathic Constipation in adults as AMITIZA (24 mcg) and is marketed by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America, Inc., (Takeda) in the U.S. for that indication.
?IBS-C has a significant impact on millions of Americans living with the condition,? said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals? founder, chairman and chief executive officer. ?We are excited that the results of our clinical studies have led to the successful filing of a supplemental New Drug Application for a lower strength of lubiprostone [8 mcg, twice daily] for IBS-C. If approved, lubiprostone may offer a new treatment option for people living with this condition.?
Approximately 58 million Americans have irritable bowel syndrome, with IBS-C accounting for approximately one-third of these cases. IBS-C symptoms include abdominal pain and discomfort associated with defecation or a change in bowel habits with features of disordered defecation.
The supplemental application is based on a clinical study program that included two Phase III, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,171 adults, followed by one long-term, open-label safety and efficacy extension trial involving 522 adults diagnosed with IBS-C. In the two Phase III studies, patients received lubiprostone 8 mcg taken twice daily (783 adults) or placebo (388 adults) over a 12-week period. In both trials, patients receiving lubiprostone 8 mcg twice daily were nearly twice as likely to achieve an overall response that was statistically significant compared to those receiving placebo (P=0.001). The long-term extension trial demonstrated that the efficacy of lubiprostone, established during the double-blinded period, continued overall improvement during the open-label extension period to the end of the 52-week program.
In the pivotal trials, lubiprostone and placebo groups showed a similar incidence of serious adverse events (1% in both the lubiprostone and placebo groups) and related adverse events (22% in lubiprostone vs. 21% in the placebo group). The most common treatment-related adverse events (greater than or equal to 5% of patients) were nausea (8% vs. 4%, respectively), diarrhea (6% vs. 4%, respectively) and abdominal pain (4% vs. 5%, respectively). The incidence of these adverse reactions was lower in the IBS-C clinical trials.
As a result of the supplemental application, Sucampo Pharmaceuticals will be entitled to receive a development milestone payment under the agreement with Takeda.