Saint-Prex, Switzerland, 11 December 2015 – Ferring Pharmaceuticals announced today that it has submitted a variation application in the Mutual Recognition Procedure (MRP) (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden and United Kingdom) in Europe to introduce its new tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label.
If approved, the proposed variation would introduce a new tailored dosing regimen as supported by the results from the OPTIMA trial. The variation application has been submitted on 28 October 2015 in the MRP with the UK as a Reference Member State (RMS).
“Sufficient data have now been collected to enable Ferring to file for official registration of this new tailored dosing regimen in the PICOPREP® label in the MRP,” said Malin Carlsson, Acting Associate Vice President at IPC Copenhagen. “If approved, it will enable the label to become in line with the guideline recommendations of shorter time interval between the last dose of the bowel preparation and the colonoscopy procedure.”
The filing is based on data from the randomised, assessor-blinded, multi-centre OPTIMA clinical trial, assessing the efficacy, safety and tolerability of the PICOPREP® tailored dosing regimen1, compared to the currently approved PICOPREP® day-before dosing regimen2 for colon cleansing, in preparation for colonoscopy.
The OPTIMA trial, started in 2014, enrolled 204 patients in Germany, France and the Netherlands. Patients were randomised (2:1) to either the PICOPREP® tailored dosing regimen or PICOPREP® day-before dosing regimen for colon cleansing in preparation for colonoscopy. Primary endpoint was the overall colon cleansing efficacy based on total Ottawa Scale (OS) scores. Key secondary endpoint was the responder status for ascending colon based on OS. Other secondary endpoints were responder status for mid (transverse, descending) and recto-sigmoid colon. Convenience, satisfaction, impact on daily activities, safety and tolerability were also evaluated.
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About PICOPREP® (sodium picosulfate, magnesium oxide, citric acid):
PICOPREP® (sodium picosulfate 10mg, magnesium oxide 3.5mg, citric acid 12g), a dual action laxative medication, is used to clean the bowel prior to X-ray examination, endoscopy and surgery when judged clinically necessary. PICOPREP® has approved dosing for children as of 1 year old and adults. This product is sold in some countries under the trademarks PICO-SALAX®, PICOLAX® or PREPOPIK®.
About Ferring Pharmaceuticals:
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.
1. In the OPTIMA trial, the time of administration of the two sachets is set according to the time of the colonoscopy for a more tailored approach. The first sachet is to be taken 10-18h, and the second sachet 4-6h before the colonoscopy.
2. In the currently approved regimen, the first sachet is to be taken at 8am the day before the procedure. The second dose is then taken 6-8h later.