Product Review
Relief for Women with Chronic Constipation
Almost everyone experiences it occasionally, some have recurrent bouts, but 15-20% of Canadians have persistent, ongoing (chronic) constipation.
It is normal to have a bowel movement as frequently as three times a day or as infrequently as three times a week, provided the stool is soft and comfortable to pass. A person experiencing constipation has hard or lumpy stool, which is difficult to pass. Chronic constipation commonly affects young children and the elderly, occurring more frequently in women than in men. There can be long-term physical and emotional consequences if sufferers do not receive effective treatment.
There are a number of products available for acute, occasional constipation, such as stool softeners and laxatives, but these treatments may have unpleasant side effects. They are not appropriate for long-term use and are ineffective for chronic constipation. This has left chronic constipation sufferers with few choices for managing the condition. When one over-the-counter medication fails to work, individuals who are chronically constipated may try product after product searching for the right treatment, which is very frustrating, expensive, and futile for some.
New Product with Unique Approach
Recently approved in Canada for the treatment of chronic idiopathic constipation in women for whom laxative treatment has failed to provide relief, prucalopride succinate (Resotran®) is an enterokinetic agent that works by targeting the serotonin (5-HT4) receptors in the gut. This once-daily, oral prescription medication stimulates muscle movement (peristalsis), usually producing a bowel movement within 2-3 hours. Spontaneous complete bowel movements then typically begin to occur within 4-5 days of starting treatment.
Evidence from clinical trials shows Resotran® to be safe and effective, and patients with chronic idiopathic constipation tolerated the treatment well. There is no indication for men to use this product, as there were an insufficient number of male patients in the clinical trials to meet Health Canada’s approval requirements in this group.
Resotran® is contraindicated for patients with renal impairment requiring dialysis, as well as patients with intestinal perforation or obstruction due to a structural or functional disorder of the gut wall, intestinal blockage, severe inflammatory bowel disease, and toxic megacolon/megarectum.
Based on the review of data looking at quality, safety, and efficacy, Health Canada considers that the benefit/risk profile of this new medication is favourable for the indication stated above.