PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Onsenal?
Onsenal is a medicine that contains the active substance celecoxib. It is available in white capsules (200 mg and 400 mg).
What is Onsenal used for?
Onsenal is used to reduce the number of polyps in patients with familial adenomatous polyposis (FAP). It is a genetic disease that causes "adenomatous intestinal polyps", growths that protrude from the lining of the colon or rectum (large intestine). Onsenal is used in addition to surgery (to remove polyps) and endoscopic monitoring (to check if polyps are developed using an endoscope, a thin tube that allows the doctor to look inside the intestine).
Since the number of patients with FAP is low, the disease is considered "rare" and Onsenal has been given the status of "orphan medicine" (a medicine used for rare diseases) on
November 20, 2001.
The medicine can only be obtained with a prescription.
How is Onsenal used?
The recommended dose of Onsenal is 400 mg twice a day during meals. The usual medical care for patients with FAP must continue.
In patients with moderate liver disease, the dose of Onsenal must be halved. Onsenal should not be given to patients with severe liver or kidney problems. Patients whose body decomposes Onsenal slowly may require a lower starting dose. The maximum recommended daily dose of Onsenal is 800 mg.
How does Onsenal work?
The active substance in Onsenal, celecoxib, is a "non-steroidal anti-inflammatory drug" (NSAID) that belongs to the group "cyclo-oxygenase 2 inhibitors (COX-2)". The substance blocks the COX-2 enzyme with consequent reduction in the production of prostaglandins, substances involved in processes such as inflammation and smooth muscle activity (muscles that perform automatic functions such as opening and closing blood vessels). COX-2 is found at high concentrations in colorectal adenomatous polyps. By blocking the activity of COX-2, celecoxib helps to slow down the
polyp formation preventing them from developing their own blood supply and increasing the speed of cell death.
What studies have been carried out on Onsenal?
Onsenal has been studied in one main study in 83 adult patients with FAP in which two doses of Onsenal were compared with placebo (a dummy treatment). In the study, 25 patients had an intact colon, but the rest of the patients had either part or all of their colon removed with surgery. The main measure of effectiveness was the reduction in the number of polyps in a given area of the colon or rectum wall after six months of treatment. A further study examined the effects of Onsenal on 18 children with FAP.
What benefit has Onsenal shown during the studies?
Onsenal at a dose of 400 mg twice a day was more effective than placebo. In adults, after six months, Onsenal had reduced the average number of polyps by 28%, while the number had dropped by 5% in patients taking placebo. Onsenal has also reduced the number of polyps in children with FAP.
What is the risk associated with Onsenal?
The most common side effects with Onsenal (seen in more than 1 patient in 10) are hypertension (high blood pressure) and diarrhea. For the full list of all side effects reported with Onsenal, see the Package Leaflet.
Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients or to sulfonamides (such as some antibiotics). It must not be used in patients with active ulcers or bleeding in the stomach or intestines or in patients who have had allergic-type reactions after taking aspirin or a "non-steroidal anti-inflammatory drug" (NSAID) including another COX-2 inhibitor . Onsenal should not be given to pregnant women or women of childbearing age, unless they use an effective method of contraception, or to women who are breast-feeding. It must not be used in patients with severe liver or kidney disease, with a disease that causes inflammation of the intestines or with certain problems affecting the heart or blood vessels. For the complete list of limitations, see the package leaflet.
Why has Onsenal been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Onsenal outweigh its risks for reducing the number of adenomatous intestinal polyps in FAP, as an adjunctive treatment to surgery and further endoscopic monitoring. The Committee noted that no effects of Onsenal on the risk of developing bowel cancer were found. The committee recommended the granting of the marketing authorization for Onsenal.
Onsenal was authorized in "exceptional circumstances". This means that since the disease is rare, it has not been possible to obtain complete information on Onsenal. The European Medicines Agency reviews each year the new information that may have become available and, if necessary, this summary will be updated.
What information is still awaited for Onsenal?
The company that makes Onsenal had previously undertaken to carry out a study on patients with FAP to gather more information on the safety and efficacy of the medicine. The company recently agreed to review the protocol of this study and to present the details of the proposed revisions to the CHMP for review. The company will also present a progress report on the study, including all safety information and a complete study report once it is completed.
More information on Onsenal:
On 17 October 2003, the European Commission issued a marketing authorization for Onsenal, valid throughout the European Union. The marketing authorization holder is Pfizer Limited. The marketing authorization was renewed on 17 October 2008.
For a summary of the opinion of the Committee for Orphan Medicinal Products on Onsenal, click here.
The full EPAR for Onsenal can be found here.
Last update of this summary: 07-2009.
