Specialty biopharmaceutical company Shire has acquired the rights to develop and market Resolor (prucalopride) in the US by agreement with Janssen.
Resolor, a prokinetic agent, is already part of Shire’s gastrointestinal (GI) drug portfolio in Europe, where it is indicated for treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
The drug is currently available in Germany, Ireland, Belgium, France, Greece and the UK, but is not approved for use in the US.
Traditional treatment options for chronic constipation are mostly laxatives in combination with dietary and lifestyle changes.
Resolor is a 5-HT4 receptor agonist. 5-HT4 receptors are found in the gut wall and are involved in the stimulation of bowel movement.
The efficacy of Resolor has been established in double-blind placebo-controlled studies. The drug is associated with common side effects including headache, nausea, diarrhoea and abdominal pain.
Resolor was developed for the European market by Belgian-based company Movetis, which acquired EU rights to the drug from Janssen. Shire acquired Movetis in 2010.
"We are excited about the opportunity to develop Resolor in the US and we look forward to working with the FDA and the GI physician community to define the path forward for registration of the medicine as a treatment for chronic constipation in the US," said Roger Adsett, Senior VP of Shire’s GI business.
Based in Ireland, Shire is a leading global specialty biopharmaceutical company specialising in ADHD, human genetic therapies, gastrointestinal diseases and regenerative medicine. The company’s in-licensing, merger and acquisition efforts are focused on specialist products with strong intellectual property protection.