Shire Receives European Approval to Use Resolor (Prucalopride) in Men for the Symptomatic Treatment of Chronic Constipation

Shire has announced that Resolor (prucalopride) has been approved by the European Medicines Agency for use in adults for the symptomatic treatment of chronic constipation in whom laxatives fail to provide adequate relief. Resolor is approved for use in women in Europe, so the new variation extends the use of this treatment to male patients.

“Constipation can cause severe symptoms, affect quality of life and lead to significant healthcare resource utilisation,” commented Professor Yan Yiannakou, Principal trial investigator of the Resolor male study and Professor of Neurogastroenterology, Durham, UK. “We know that laxatives are often inadequate or unsatisfactory for patients with chronic constipation. The availability of prucalopride for men now offers an effective treatment option when laxatives fail to provide symptom relief.”

The efficacy, safety and tolerability of Resolor in male patients with chronic constipation were evaluated in a 12-week, multicentre, randomised, double-blind, placebo-controlled study (N=370). The data showed that a statistically significantly higher percentage of subjects in the Resolor group (37.9%) experienced normal bowel function, as assessed by an average of ≥3 spontaneous complete bowel movements (SCBMs) per week, compared with subjects in the placebo treatment group (17.7%) (p<0.0001) over the 12-week treatment period. The most common adverse events associated with Resolor were headache and gastrointestinal disorders. The safety profile of Resolor was consistent with that seen in studies of female patients.

“The extension of the Resolor label to include use in men is an important development in the treatment of chronic constipation,” said Roger Adsett, Head of the Gastrointestinal and Internal Medicines Business Unit at Shire. “We are pleased to now be able to offer the benefits of Resolor to even more chronic constipation patients in need of treatment options.”

Resolor was first approved in Europe in 2009 for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.1