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Sucampo submits lubiprostone sNDA for constipation predominant IBS

Sucampo Pharmaceuticals has submitted a supplemental New Drug Application to the FDA to seek market approval of a lower strength of lubiprostone to treat irritable bowel syndrome with constipation

US-headquartered Sucampo Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the FDA to seek market approval of a lower strength of lubiprostone (8?g) to treat irritable bowel syndrome with constipation (IBS-C).

Lubiprostone is approved for the treatment of chronic idiopathic constipation in adults as Amitiza (24?g) and is marketed by Sucampo and Takeda Pharmaceuticals North America (Takeda) in the US for that indication.

The supplemental application is based on a clinical study programme which included two phase III, multi-centre, double-blind, randomised, 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?g taken twice daily (783 adults) or placebo (388 adults) over a 12-week period. In both trials, patients receiving lubiprostone 8 ?g twice daily were nearly twice as likely to achieve an overall response that was statistically significant compared to those receiving placebo.

The long-term extension trial demonstrated that the efficacy of lubiprostone, established during the double-blind period, continued overall improvement during the open-label extension period to the end of the 52-week programme.

The lubiprostone and placebo groups showed a similar incidence of serious adverse events (one per cent in both the lubiprostone and placebo groups) and related adverse events (22 per cent in lubiprostone compared with 21 per cent in the placebo group).

The most common treatment-related adverse events were nausea (eight per cent compared with four per cent, respectively), diarrhoea (six per cent compared with four per cent) and abdominal pain (four per cent compared with five per cent). 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.

Ryuji Ueno, Sucampo Pharmaceuticals' founder, chairman and CEO, said: "IBS-C has a significant impact on millions of Americans living with the condition. 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?g, twice daily) for IBS-C. If approved, lubiprostone may offer a new treatment option for people living with this condition."

18th July 2007

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