ePillz.com - Acomplia Enters North America, but Not the USA

Acomplia Enters North America, but Not the USA

November 09, 2006 - Sanofi-Aventis -

Acomplia (generic name: rimonabant) has received the first marketing authorization in the North America. Mexican Health Authorities approved Acomplia for use as the therapeutic means to treat overweight and obese patients. Acomplia is recommended to be used as one of the components of obesity treatment along with diet and exercising.

Rimonabant, discovered and developed by French pharmaceutical company Sanofi-Aventis, is a brand-new anti-obesity drug that gave rise to excitement among the obese patients as well as to many controversial disputes among medical experts.

After Acomplia approval in all 25 countries of the European Union in June 2006, many obese Americans wait impatiently for the approval of this novel drug on the territory of the USA. However, it is Mexico that became the first country in the North American continent, granting marketing authorization for rimonabant.

The American Food and Drug Administration received the application from Sanofi-Aventis in 2005, but in February 2006 the FDA declined to issue the final approval until a number of concerns were resolved. Though the exact reasons are not known, the adverse reactions are most likely to raise concerns among the FDA experts.

On October 31, 2006 Sanofi-Aventis reported that it had finally completed the response to the FDA, but the company did not make any forecast about the possible timeline for rimonabant to enter the American market. It is only reported that rimonabant is likely to be marketed in the USA under the brand name Zimulti.

So, while Acomplia 20mg tablets are already available for patients in Mexico and many European countries, the destiny of the novel anti-obesity drug in the USA is still undefined.

About rimonabant (Acomplia/Zimulti) Since the times of phentermine, rimonabant seems to be the next “magic” pill in fighting obesity. In fact it is the appetite suppressant, but it works uniquely by influencing the endocannabinoid system, which is believed to play an important role in regulating food intake and energy balance.

The excitement around rimonabant stems not only from the fact that the medication may significantly accelarate weight loss, but to the additional benefits, ensured by the treatment. The clinical study of Acompia showed its ability to reduce abdominal fat along with the total weight loss. Besides, Acomlia influenced positively the cardiovascular system of the patients, increasing the levels of good cholesterol and reducing triglycerides.

Safety profile of Acomplia is the most disputable issue. According to the official study 15.7% of patients receiving Acomplia discontinued treatment because of side effects. Nausea was noted to be the most common adverse reaction. Other side effects were depressive disorders, mood alterations, anxiety, irritability, sleep disorders, memory loss and dizziness.

Nick

External resources
http://en.sanofi-aventis.com
http://www.drugdevelopment-technology.com/projects/rimonabant/
http://www.acompliareport.com/