EPAR summary for the public
What is ACOMPLIA?
ACOMPLIA is a medicine containing the active substance rimonabant. It is available as white, teardrop- shaped tablets.
What is ACOMPLIA used for?
ACOMPLIA is used together with diet and exercise to treat adult patients:
The medicine can only be obtained with a prescription.
How is ACOMPLIA used?
ACOMPLIA is taken as one tablet once a day, before breakfast. The patients should also follow a reduced calorie diet and increase their level of physical activity. The medicine should not be used in patients who have severe problems with their liver or their kidneys.
How does ACOMPLIA work?
The active substance in ACOMPLIA, rimonabant, is a cannabinoid receptor antagonist. It acts by blocking Medicinala specific type of receptor, the cannabinoid type 1 (CB1) receptors. These receptors are found in the
nervous system, and they are part of the system the body uses to control food intake. The receptors are also found in adipocytes (fat tissue).
How has ACOMPLIA been studied?
The effects of ACOMPLIA were first tested in experimental models before being studied in humans. Four studies of ACOMPLIA in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg. One study looked more particularly at patients with abnormal levels of blood fat, and one at patients with type 2 diabetes. The
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studies compared the effect of ACOMPLIA with that of a placebo (a dummy treatment) on weight loss over one to two years. One study also looked at how this loss could be maintained during the second year. Four studies of ACOMPLIA as a help to stop smoking were also carried out in over 7,000 patients, comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one of the studies) on smoking cessation, and on relapses in the following year.
What benefit has ACOMPLIA shown during the studies?
After one year, all patients who received ACOMPLIA lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the difference in the weight loss was 3.9 kg. The medicine also reduced the risk of regaining weight.
The studies in smoking cessation did not show consistent results, and the effect of ACOMPLIA in this area was difficult to estimate. The company decided to withdraw its application for smoking cessation. Therefore, ACOMPLIA is not recommended as an aid for smoking cessation
What is the risk associated with ACOMPLIA?
reported with ACOMPLIA, see the Package Leaflet.
ACOMPLIA should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding. It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of depression, including thoughts about suicide in a small minority of patients. Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment. Caution should be
Why has ACOMPLIA been approved?
used when taking ACOMPLIA with some medicines, such as ketoconazole or itraconazole
The Committee for Medicinal products for Human Use (CHMP) concluded that ACOMPLIA had shown
dyslipidaemia. The Committee recommended that ACOMPLIA be given marketing authorisation.
its effectiveness in weight reduction in obese or overweight patients with associated risk factors. The Committee decided that ACOMPLIA’sproductbenefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or
Which measures are being taken to ensure the safe use of ACOMPLIA?
The company that makes ACOMPLIA will put in place a programme to ensure that the medicine is used in patients who need it for health, rather than for cosmetic reasons, by providing educational packs for patients and doctors, and to monitor how the medicine is used. The company will use specific databases to monitor ACOMPLIA’s side effects, especially those linked to the nervous system.
Other information about ACOMPLIA:
The European Commission granted a marketing authorisation valid throughout the European Union for ACOMPLIA to
The full EPAR for ACOMPLIA can be found here.
This summary was last updated in