Onsenal - celecoxib

PLEASE NOTE: MEDICINAL PRODUCT 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). This is a genetic disease that causes "adenomatous intestinal polyps", growths that protrude from the inner lining of the colon or rectum (large intestine). Onsenal is used in addition to surgery (to remove polyps) and endoscopic monitoring (to check for polyps using an endoscope, a thin tube that allows the doctor to look inside the intestine).
Because the number of patients with FAP is low, the disease is considered 'rare' and Onsenal has been designated an 'orphan medicine' (a medicine used in rare diseases).
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 with meals. Usual medical care for patients with FAP must continue.
In patients with moderate liver disease, the dose of Onsenal should be halved. Onsenal must not be given to patients with severe liver or kidney problems. A lower starting dose may be needed in patients whose body breaks down Onsenal slowly. 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 'cyclooxygenase2 (COX-2) inhibitors' group. The substance blocks the COX-2 enzyme resulting in a 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 in high concentrations in adenomatous colorectal polyps. By blocking the activity of COX-2, celecoxib helps slow it down
formation of polyps preventing them from developing their own blood supply and increasing the rate of cell death.

How has Onsenal been studied?

Onsenal was studied in one main study involving 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 part or all of their colon removed by surgery. The main measure of effectiveness was the reduction in the number of polyps in a given area of ​​the colon wall or rectum after six months of treatment. A further study looked at 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 daily 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 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 in 10 patients) are hypertension (high blood pressure) and diarrhea. For the full list of side effects reported with Onsenal, see the package leaflet.
Onsenal must not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients or to sulphonamides (such as some antibiotics). It must not be used in patients with active ulcer 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 potential, unless they are using effective contraception, or to women who are breastfeeding. It should not be given to patients with severe liver or kidney disease, with a disease that causes inflammation of the gut or with certain problems affecting the heart or blood vessels. For the full list of restrictions, see the Package Leaflet.

Why has Onsenal been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Onsenal's benefits are greater than its risks for reducing the number of adenomatous intestinal polyps in FAP, as an adjunct to surgery and further endoscopic monitoring. The Committee has noted that there was no effect of Onsenal on the risk of developing bowel cancer. The committee recommended the granting of a marketing authorization for Onsenal.
Onsenal was cleared under "exceptional circumstances". This means that, as the disease is rare, it has not been possible to obtain complete information on Onsenal. The European Medicines Agency reviews every year any 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 a study in patients with FAP to gather more information on the medicine's safety and efficacy. The company recently agreed to review the protocol for this study and to submit the details of the proposed revisions to the CHMP for review. The company will also submit a progress report on the study, including all safety information and a full report on the study once it is completed.

Other information about Onsenal:

On October 17, 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 it was renewed on October 17, 2008.
For the summary of the opinion of the Committee for Orphan Medicinal Products for Onsenal, click here.
For the full version of the Onsenal EPAR click here.

Last update of this summary: 07-2009.


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