Source: DGNews  |  Posted 2 years ago

NEW YORK -- November 19, 2009 -- The Swiss Agency for Therapeutic Products has granted a marketing authorization for lubiprostone (Amitiza) 24 mcg gel capsules for the long-term treatment of patients with chronic idiopathic constipation.

The approval was based upon an assessment of safety and efficacy data obtained from a comprehensive clinical development program, including results of 2 randomised phase 3 studies in adult patients with chronic idiopathic constipation conducted in the United States.

The pooled data from these trials showed that 60% of patients treated with lubiprostone experienced a spontaneous bowel movement (SBM) within 24 hours of treatment and 80% experienced an SBM within 48 hours of treatment, compared with 35% and 63% of placebo patients, respectively (P < .0001).

In addition, lubiprostone showed improvement in long-term symptom relief of irritable bowel syndrome, with significant improvements in constipation severity, abdominal bloating and abdominal discomfort for up to 12 months.

The most common adverse reactions (incidence >4%) were nausea, diarrhoea, headache, abdominal pain, abdominal distention, and flatulence.

SOURCE: Sucampo Pharmaceuticals