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Shire Acquires US Rights to Resolor® (prucalopride)
Date:1/10/2012

160;Resolor is not currently approved for use in the US.

Important Safety Information

Healthcare professionals in the EU should consult the Resolor Prescribing Information before prescribing, particularly in relation to hypersensitivity to any of the constituents, renal impairment requiring dialysis, intestinal perforation or obstruction, obstructive ileus, severe inflammatory conditions of the intestinal tract, severe and clinically unstable concomitant diseases, in particular arrhythmias or ischaemic cardiovascular disease. Based on placebo-controlled clinical study data, very common side effects associated with Resolor are headache, nausea, diarrhoea, abdominal pain, occurring predominantly at the start of therapy and usually disappearing within a few days with continued treatment; common side effects are dizziness, vomiting, dyspepsia, rectal haemorrhage, flatulence, abnormal bowel sounds, pollakiuria, fatigue. The efficacy of prucalopride has been established in double-blind placebo-controlled studies for up to 3 months. Reassess periodically the benefit in case of prolonged treatment. In the EU, detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.

About chronic constipation

Chronic constipation is characterized by infrequent and difficult passage of stools over a prolonged period and a range of bothersome symptoms. Traditional treatment options for chronic constipation consist mainly of dietary and lifestyle changes in combination with laxatives.

 

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in
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