Shire receives European approval to use Resolor (prucalopride succinate) in men for the symptomatic treatment of chronic constipation

EMA

Shire plc announced today that Resolor (prucalopride succinate) has been approved by the European Commission 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 succinate for men now offers an effective treatment option when laxatives fail to provide symptom relief.”

For more details, go to: https://www.shire.com/newsroom/2015/june/resolor-eu-male-indication-press-release

Michael Wonder

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Michael Wonder

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