As a result of this supplemental new drug application (sNDA) approval, Sucampo will receive a development milestone payment of $50 million from Takeda in accordance with the collaboration and license agreement between Sucampo and Takeda to jointly market Amitiza in the US and Canada.
The sNDA was based on a clinical study program that included two Phase III, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,154 adults, followed by one long-term, open-labeled extension trial involving 476 adults diagnosed with irritable bowel syndrome with constipation (IBS-C).
Art Rice, general manager, gastroenterology, of Takeda Pharmaceuticals North America, said: “We are prepared to rapidly roll out our extensive efforts together with Sucampo Pharmaceuticals to educate both physicians and adult women with IBS-C to help them understand the condition and how it may be treated with Amitiza.”