Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for Amitiza® (lubiprostone) 24 microgram (mcg) gel capsules for the long-term treatment of patients with chronic idiopathic constipation (CIC).
This is the first European regulatory approval for Sucampo and Amitiza is the first prescription medicine to be approved in Switzerland for the long-term treatment of CIC. Amitiza is already approved by the U.S. Food and Drug Administration (FDA) for the long-term treatment of CIC in adults and for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women. Amitiza is the only prescription medicine approved by the FDA for either of these indications.
Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, Inc., said, “This approval gives doctors in Switzerland a safe, effective and long-term treatment option for their patients with chronic idiopathic constipation, a life-altering disorder. This decision further validates Amitiza’s position as a safe and effective therapy for a chronic condition.”
Sucampo is now working on the next steps toward pricing and reimbursement to determine distribution alternatives. Sucampo’s goal is to have Amitiza available for eligible patients in Switzerland.
This decision by Swissmedic marks an important milestone in Sucampo’s global development and commercialization plan of lubiprostone for CIC, IBS-C and other indications.
The marketing authorization of Amitiza in Switzerland was based upon an assessment of safety and efficacy data obtained from a comprehensive clinical development program, including results of two randomized pivotal phase 3 clinical trials in adult CIC patients conducted in the U.S. The pooled data from these trials showed that 60 percent of patients treated with Amitiza experienced a spontaneous bowel movement (SBM) within 24 hours of treatment and 80 percent experienced an SBM within 48 hours of treatment, compared to 35 percent and 63 percent of placebo patients, respectively (p<0.0001). Moreover, Amitiza showed improvement in long-term symptom relief of this disorder, with significant improvements in constipation severity, abdominal bloating and abdominal discomfort for up to 12 months.