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."
- Ends -
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 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.
References:
1. 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.
2. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for
colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.
3. Hassan C, Bretthauer M, Kaminski MF, et al. Bowel preparation for
colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE)
Guideline Endoscopy 2013;45:142-150.
4. 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.
5. 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.
View source version on businesswire.com:
http://www.businesswire.com/news/home/20160627005809/en/
Contact:
Ferring Pharmaceuticals
Helen Gallagher
Tel. +41 58 301 00 51
or
Nicole Barraud-Estoppey
Tel. +41 58 301 00 53
ClickThru URL:
Multimedia Gallery URL:
