EMA approves Resolor for use in men for the symptomatic treatment of chronic constipation

Shire’s 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.

Chronic constipation is characterised by infrequent and difficult passage of stools over a prolonged period, and includes a range of symptoms. It is estimated to affect up to 14% of the population, with an incidence rate of 17% in women and 9% in men. It is often a persistent condition that can impact significantly on a patient’s quality of life. Resolor is a selective, high-affinity 5-HT4 receptor agonist, which helps to stimulate bowel motility.

“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.”

Resolor was first approved in 2009 for the symptomatic treatment of chronic constipation in women

The efficacy, safety and tolerability of Resolor in male patients with chronic constipation were evaluated in a 12-week study. The data showed that a statistically significantly higher percentage of subjects in the Resolor group experienced normal bowel function compared with subjects in the placebo treatment group. 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.