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 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.
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.
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.
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
21st Century Fox to Spin off Businesses and Create New “Fox”; a Growth Company Centered on Live News and Sports Brands and the Iconic Fox Brand14.12.2017 12:12 | Pressemelding
Twenty-First Century Fox, Inc. (“21st Century Fox” or the “Company” – NASDAQ: FOXA, FOX) today announced that it intends to spin off to 21st Century Fox shareholders a portfolio of its highly-rated news, sports and broadcast businesses to create a new “Fox,” which will be a growth company centered on live news and sports brands, anchored by the strength of the Fox Network. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171214005660/en/ Left to right: Robert A. Iger, Chairman and CEO of The Walt Disney Company, and Rupert Murdoch, Executive Chairman, 21st Century Fox (Photo: Business Wire) The new “Fox” will include iconic branded properties Fox News Channel, Fox Business Network, Fox Broadcasting Company, Fox Sports, Fox Television Stations Group, and sports cable networks FS1, FS2, Fox Deportes and B
First Eagle Investment Management to Absorb Costs of External Research14.12.2017 11:00 | Pressemelding
First Eagle Investment Management announced today that effective January 3, 2018, it will absorb the costs of all external research purchased by First Eagle investment teams. Industry practices regarding payments for external research are evolving due to the Markets in Financial Instruments Directive II (MiFID II), an EU directive requiring the unbundling of external research costs from trade execution costs. As a result, asset managers worldwide have been considering whether to pass the costs of external research to their clients or to pay them from their own resources. “While our firm is not subject to MiFID II, we believe that this part of the directive points the way forward for our industry,” said Mehdi Mahmud, President and Chief Executive Officer of First Eagle Investment Management. “To be equitable and consistent across our entire client base, we have decided to use
Cognitec Brings Unique Video Investigation Features to Face Recognition Product for Law Enforcement14.12.2017 09:38 | Pressemelding
Cognitec Systems, the face recognition company, has significantly extended the feature set of its FaceVACS-DBScan product. The latest release combines the company’s renowned image database search technology with powerful video inspection tools for a multitude of investigation use cases. FaceVACS-DBScan LE enables fast import of video footage and detailed investigations of the extracted facial images. Agents can find known or unknown persons in multiple videos to quickly narrow down suspect investigations. The investigation can reveal, for example, if a suspect was seen in various locations within a set time window, always with the same group of persons, or in one location too many times during the day. With one click, the investigator can add the facial image seen in a video frame to a local database. If a person is already known, the technology can quickly compare
The Idle Man Signs Extension with Radial to Support International Business Growth14.12.2017 08:00 | Pressemelding
Radial, the leader in omnichannel commerce technology and operations, today announced London-based menswear fashion retailer, The Idle Man, has signed an extension with Radial to support its international growth and expansion plans. The extension follows Radial’s ability to quickly launch fulfilment, international shipping, and customer service solutions on behalf of The Idle Man from its U.K.-based operations center in Manchester, in just three months. Radial’s services have improved overall customer satisfaction as The Idle Man expands its international footprint. Founded in 2014 by Oliver Tezcan, former menswear buying manager at Asos.com, The Idle Man was established to fill the gap left by mainstream retailers for fashionable men’s clothing at affordable prices. Quickly becoming the third largest menswear destination in the U.K., with over 1.5 million unique visits each mon
SES Drives 5G Satellite Demonstration Testbed Initiative with ESA14.12.2017 07:55 | Pressemelding
SES is expanding its efforts to support 5G developments as part of ESA’s ARTES project, SATis5, where it will be enabling demonstrations of satellite-terrestrial integration for 5G networks. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171213006286/en/ SES Drives 5G Satellite Demonstration Testbed Initiative with ESA (Photo: Business Wire) The testbed infrastructure will comprise SES's fleet of Geostationary Earth Orbit (GEO) and Medium Earth Orbit (MEO) satellites, which will be integrated with terrestrial networks and state-of-the-art technologies. In addition to providing the space segment, SES's headquarters in Luxembourg will also host a SATis5 testbed node with prototypes of networks for satellite integration, along with other nodes located in Berlin and Erlangen, and an additional portable no
Alibaba Cloud Becomes the First Cloud Computing Company to Obtain C5 Attestation with Additional Requirements14.12.2017 07:00 | Pressemelding
Alibaba Cloud, the cloud computing arm of the Alibaba Group, announced today that it had completed its assessment for the Cloud Computing Compliance Controls Catalogue (C5) set out by the Federal Office for Information Security in Germany, also known as Bundesamt für Sicherheit in der Informationstechnik (BSI). Alibaba Cloud is the world’s first cloud provider to achieve this attestation with the additional requirements. The attestation covers Elastic Compute Service (“ECS”), Relational Database Service (“RDS”), Object Storage Service (“OSS”), Content Delivery Network (“CDN”), Server Load Balancer (“SLB”), Virtual Private Cloud (“VPC”) and Alibaba Cloud Security available on Alibaba Cloud’s regions in Singapore and Germany. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171213006271/en/ Alibaba Cloud becomes t
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom