TURNHOUT, Belgium, July 27 /PRNewswire/ -- Movetis, the GI specialty pharmaceutical company based in Belgium announces today that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on the European Marketing Authorisation Application (MAA) for its lead product, prucalopride for the treatment of chronic constipation (CC).
The prucalopride MAA was submitted to the EMEA in May 2008. The CHMP opinion for prucalopride will now be forwarded to the European Commission, which will decide on whether to approve the MAA within 60 to 90 days after the CHMP opinion. If approved, Prucalopride will be the first oral compound for the treatment of severe chronic constipation to be approved in the 27 member states of the European Union.
Prucalopride is the first compound of a new class of highly selective serotonin (5-HT4) receptor agonists with strong enterokinetic activity. In its positive opinion, the CHMP supports the indication for the symptomatic treatment of chronic constipation in women for whom laxatives provide inadequate relief.
Chronic constipation is a general disorder of the gastrointestinal tract that affects more than 30 million female patients in Europe. It is a prevalent and debilitating condition with a clear impact on quality of life. Various peer reviewed publications support that patients using this new treatment see their bowel motility improving and the constipation related symptoms decreasing, which leads to patient satisfaction and better quality of life.
On the news from the EMEA, Staf Van Reet, Chairman of the board, stated: This positive opinion validates years of product development in a difficult field and brings a new and much needed treatment option to this patient population. We are delighted with the decision of the CHMP and look forward to EU approval.
Dirk Reyn, CEO, noted: If this positive opinion is indeed confirmed by an approval from the EU Commission, this will transform Movetis from a start-up development company into an integrated GI specialty company with products in discovery, development and commercial stages. The Resolor team, under the leadership of Lieve Vandeplassche (VP Clinical Development), Remi Van Den Broeck (CDO) and Jan Schuurkes (CSO), together with the other employees of Movetis and the external consultants that helped us, have all done an outstanding job.
Prucalopride has been tested in 2,752 patients (including elderly) in double-blind randomized placebo-controlled studies up to 12 weeks of treatment, including three identically designed pivotal phase III studies with patients presenting an average history of 20 years of chronic constipation.
In contrast to laxatives, prucalopride triggers a physiological and peristaltic reflex in the colon through stimulation of the 5HT4-receptors on the intramural nerves. This accelerates overall transit along the GI tract, induces colonic mass movement and significantly enhances colonic emptying. Prucalopride stimulates bowel function by specifically targeting the underlying impaired motility and as a result it alleviates a broad range of chronic constipation symptoms and improves patient satisfaction.
About chronic constipation
Chronic constipation is a general disorder of the gastrointestinal tract that affects an estimated 80 million people worldwide and at least 37 million in Europe. The population that visits their physician consists of more than 80 % females. It is a prevalent and debilitating condition with a clear impact on quality of life. The ROME III guidelines define chronic constipation as two or more of the following symptoms at least a quarter of the time for at least six months: straining, lumpy or hard stools, a sensation of incomplete evacuation, a sensation of anorectal obstruction or blockage, and/or less than 3 defecations per week. In many cases available prescription and over the counter drugs offer inadequate treatment.
Through a clear focus on gastroenterology (GI), Movetis seeks to improve the lives of millions of patients - both adults and children - by discovering, developing and ultimately commercializing innovative treatments targeting GI conditions with a high unmet medical need. Movetis NV - was founded in Belgium in December 2006.
For further inquiries, please contact: Ingrid Jansen Movetis Tel +3214404390 E-mail firstname.lastname@example.org http://www.movetis.com
SOURCE: Movetis NV
For further inquiries, please contact: Ingrid Jansen, Movetis, Tel +3214404390, E-mail email@example.com.