ACOMPLIA ( active ingredient in Acomplia is rimonabant) approved in the European Union as an adjunct to diet and exercise for the treatment of obese patients.
If approved in the United States, it is intended to be marketed under the name Zimulti.

Rimonabant, discovered and developed by French pharmaceutical company Sanofi-Synthelabo.

In Europe, it is indicated for use in conjunction with diet and exercise for patients with a body mass index
greater than 30 kg/m2, or patients wih a BMI greater than 27 kg/m2 with associated risk factors, such as type 2
diabetes or dyslipidaemia.

Rimonabant acts by selectively blocking CB1 receptors found in the brain and in peripheral organs important in glucose and lipid (or fat) metabolism, including adipose tissue, the liver, gastrointestinal tract and muscle.
CB1 receptor blockade with ACOMPLIAН acts to decrease the overactivity of the endocannabinoid system (EC system). The EC system is a recently characterised physiological system that includes receptors such as the CB1 receptor and it has been shown to play an important role in regulating body weight and in controlling energy balance, as well as glucose and lipid (or fat) metabolism.

In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies. The patients included in the phase 3 trials followed a restrictive diet during the trial prescribed by a dietician and they were advised to increase their physical activity. Patients had a BMI GREATER-THAN OR EQUAL TO 30 kg/m2 or BMI >27 kg/m2 with hypertension and/or dyslipidemia at inclusion. Approximately 80% of the population were women, 87% Caucasian and 9% Black. Experience in patients over 75 years and Orientals/Asians was limited.
In clinical trials, over one year 33% of patients lost more than 10% of their initial bodyweight, with nearly two thirds of patients losing over 5%.
Most of the observed weight reduction was obtained within the first nine months of treatment. ACOMPLIA 20 mg was effective in maintaining weight loss up to two years. Weight loss at two years was 5.1 kg for patients who received ACOMPLIA 20 mg and 1.2 kg for placebo.
The effects on body weight appeared to be consistent among men and women. In the limited number of Black patients weight loss was less pronounced.

Method of administration
In adults, the recommended dosage is one 20 mg tablet daily to be taken in
the morning before breakfast.
The treatment should be introduced with a mildly reduced calorie diet.
The safety and efficacy of rimonabant have not been evaluated beyond 2 years.

Side Effects of Acomplia
Nausea, vomitting and other gastrointestinal disorders were relatively common side effects of taking Acomplia.
Disorders of the nervous system includes: headaches, faintness and feeling dizzy.
Psychiatric disorders Including: mood swings, anxiety, depression, irritability, sleep disorders and other similar disorders. If you already have a history of mental health disorders, it would be highly adviseable to mention this to your doctor before obtaining Acomplia.

Warnings and precautions
ACOMPLIA should be used with caution in patients over 75 years of age.
ACOMPLIA should be used with caution in patients with moderate hepatic impairment. ACOMPLIA should not be used in patients with severe hepatic impairment.
No dosage adjustment is required for patients with mild and moderate renal impairment. ACOMPLIA should not be used in patients with severe renal impairment.
ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.

Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)
Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take ACOMPLIA.

Experience with rimonabant in overdosage is limited. In a single-dose tolerability study, doses up to 300 mg were administered to a limited number of subjects with only minor symptoms reported. These included headache, euphoria, fatigue and insomnia. The pharmacokinetic profile demonstrates that a plateau in exposures is reached at 180 mg. There is no specific antidote for rimonabant; therefore, appropriate supportive measures should be initiated in case of overdose. Treatment should consist of the general measures employed in the management of overdoses, such as keeping airways unobstructed, monitoring cardiovascular function and general symptomatic and supportive measures.

Rimonabant may also be found to be effective in assisting some smokers to quit smoking. Sanofi-Aventis is
currently conducting studies to determine the possible value of rimonabant in smoking-cessation therapy.