Ferring Pharmaceuticals announces approval of new tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label in MRP countries in Europe
Ferring Pharmaceuticals has successfully finalised a Mutual Recognition Procedure (MRP) submitted in Europe on 28 October 2015 with the UK as a Reference Member State (RMS). The proposed variation introduces a tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label as supported by the results of the OPTIMA trial. National Marketing Authorisations are expected in the majority of EU countries in the following months.
Saint Prex, Switzerland – 27 June 2016 –
Ferring Pharmaceuticals today announced that the tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label has received approval in the MRP countries in Europe.
The approval is based on data from the OPTIMA clinical trial demonstrating that the PICOPREP® tailored dosing regimen was superior in providing good to excellent visibility in the entire colon compared to the currently approved PICOPREP® day-before dosing regimen1.
In the tailored dosing regimen, 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 to 18 hours before, and the second sachet 4 to 6 hours before the colonoscopy in line with guideline recommendations3–5.
The time interval between the last dose of the bowel preparation and the colonoscopy procedure can be considered the most important determinant of colon cleansing quality2, with shorter time intervals associated with colon cleansing of higher quality2–5.
“The approval is a significant milestone in aligning the label with the guideline recommendations of shorter time interval between the last dose of the bowel preparation and the colonoscopy procedure3–5,” said Pascal Danglas, MD, Chief Medical Officer, Ferring Pharmaceuticals. “Compared to the current day-before dosing regimen, tailored dosing of PICOPREP® results in higher quality colon cleansing enabling more successful colonoscopies1.”
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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 one year old and adults. This product is sold in some countries under the trademarks PICO-SALAX®, PICOLAX® or PREPOPIK®.
About OPTIMA trial
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.
About Ferring Pharmaceuticals
Headquartered in Saint-Prex, 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-oncology, gastroenterology, endocrinology and orthopaedics. Ferring Pharmaceuticals has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
To learn more about Ferring Pharmaceuticals or its products please visit www.ferring.com.
- Kiesslich R, Angelin C, Raymond K, et al. A randomised, assessor-blinded, multicentre trial comparing the efficacy, safety, and tolerability of a new tailored dosing regimen to day-before dosing regimen of colon cleansing agent used before colonoscopy. J Crohn Colitis 2016;10,suppl.1:S278.
- Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.
- Hassan C, Bretthauer M, Kaminski MF, et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline Endoscopy 2013;45:142-150.
- Mathus-Vliegen E, Pellise M, Heresbach D, et al. Consensus guidelines for the use of bowel preparation prior to colonic diagnostic procedures: colonoscopy and small bowel video capsule endoscopy Curr Med Res Opin 2013; 29: 931 – 945.
- Johnson DA, Barkun AN, Cohen LB, et al. Optimizing adequacy of bowel cleansing for colonoscopy recommendations from the US Multi-Society Task Force on colorectal cancer. Gastroenterology 2014;147:903–924.