Rimonabant Acomplia

Acomplia (Rimonabant / Zimulti) received a major boost in the U.K. on March 26th when the National Institute for Health and Clinical Excellence recommended that acomplia will be made available to obese and overweight patients through the National Health Service.

The National Institute for Health and Clinical Excellence (NICE) assesses the cost-effectiveness of treatments for use by the state-run National Health Service, and its endorsement of provision of Acomplia to patients stands in contrast to a German panel’s decision classifying it as a “lifestyle” drug that would not be reimbursed by the country’s health insurance.

The fact that obese and overweight patients in Britain and Wales will soon be able to receive the costly drug as part of their government health coverage should provide a boost to Acomplia sales, which have been a major disappointment totaling only $123 million worldwide last year.

Hopes for Acomplia, once touted as a multibillion-dollar blockbuster drug, took a major hit last year when a U.S. FDA advisory panel recommended against its approval after it was linked to depression and suicidal thoughts. Sanofi-Aventis has said it hopes to present new clinical trial results to regulators in 2009.

“Sanofi-Aventis is delighted that NICE has recommended that Acomplia should be made available for the management of obese and overweight National Health Service (NHS) patients, and believes that Acomplia is a valuable addition to the limited treatment options currently available,” Sanofi said in a statement.

Dr David Haslam, Clinical Director of Britain’s National Obesity Forum, said: “It is excellent news that NICE has recognized that doctors should be able to prescribe rimonabant on the NHS for the right patient.

“Patients who are obese or overweight are at significant risk of developing heart disease and type 2 diabetes, so it is vital that doctors have a full range of options, alongside lifestyle interventions, to help patients lose weight and cut their risk of disease,” Haslam said.

“Acomplia, in addition to diet and exercise, provides clinically meaningful weight loss and improvements in risk factor for cardiovascular disease. We
now need to make sure that when final guidance is issued primary care trusts provide funding to allow doctors to be able to provide the medicine to those patients who could benefit from it,” he added.

While millions of obese people are excited at Acomplia’s potential in helping them reduce their weight, some researchers believe this novel drug could have a major role to play in helping smokers break the cigarette habit — even though regulators on the first go-round refused to approve it for this use.

Acomplia is the first in a new class of drugs that works by inhibiting the CB1 receptor, one of two receptors found in the EndoCannabinoid System (or EC System) that are located in the brain and other parts of the body.

While the EC System is associated with regulating the body’s intake of food, it also is involved in tobacco dependency. Chronic tobacco use over-stimulates the EC system creating an imbalance. Acomplia, by blocking the CB1 receptor, helps restore balance to the EC system resulting in reduced dependence on tobacco.

Acomplia has “roughly doubled the odds of quitting smoking,” said Dr. Robert Anthenelli, associate professor of psychiatry at the University of Cincinnati College of Medicine in Ohio. “We also found remarkably reduced postcessation weight gain: a 77% reduction versus placebo….

“These dual effects on smoking cessation and reduced weight gain make rimonabant a promising agent for treating tobacco dependence,” Anthenelli added

But while the initial smoking-cessation trial seemed pomising, results from a second trial were less encouraging and Sanofi was denied approval for use of Acomplia as a smoking cessation aid by both the U.S. Food and Drug Administration and the European Medicines Agency (EMEA).

The regulators asked for an additional clinical trial of Acomplia as aid to helping break the smoking habit, and Sanofi has not yet indicated whether it intends to proceed with such a trial.

Article From acompliareport.com

Sanofi Aventis, a large cap French pharmaceutical firm developed an effectual weight loss medication, Acomplia. This weight loss medication is to be employed is association with a proper diet plan and regular exercise regime to attain effective results.

Weight loss medication Acomplia is a product of 2 years of clinical trials undertaken in North America. Weight loss is not the only benefit which is sourced by use of this diet pill. Usage of this weight loss medication has also proven to be beneficial in improvement of cardio-metabolic risk factors, smoking cessation, and even minimization of chances of weight gain.

This weight loss medication has been in the news ever since its launch in the year 2006. At present, it is approved for sale in the UK, Switzerland, France, Germany, Ireland, Brazil, Mexico, and even UAE amid other countries.

Although it hasn’t yet received FDA approval for sale in the US but a trade name for its sale in the US Zimulti has already been decided. Sanofi Aventis is hopeful about its approval in the future, for which a fresh 50-month trials are already on their way, estimated to be completed in the year 2010. It seems that it would be until these trials are completed that the FDA would reconsider its decision on usage of this diet pill in the US.

It works upon the mechanism of appetite suppressant, and in this way beneficial in weight loss. Excessive desire to eat is the prime reason for weight gain, a medication which could reduce this urge can effectively facilitate trimming down of your body shape. Use of this medication is suggested to be employed with a proper diet plan and regular exercise plan for attainment of desired results.

Usage of this medication is intended for individuals with a BMI 30; or BMI 27 along with obesity related risk factors such as high cholesterol or type 2 diabetes. In order to ascertain the suitability of the medication, speak with your general practitioner before initiating this weight loss medication.

On April 3rd Sanofi-Aventis published that it still has high hopes for Rimonabant (Acomplia / Zimulti) to get aproval from the FDA in US, even though it was rejected by an advisory panel last year and recent clinical trial news has been less than wildly encouraging.

Marc Cluzel, Sanofi’s head of research, said in a round of interviews in London that he continues to believe Rimonabant can be a winner.

Another Sanofi executive, Belen Garijo, also expressed confidence that sales of Acomplia — which have been disappointing to date — will grow in Europe and other countries where it is on the market.

“We are very confident that Acomplia will grow in Europe,” Garijo told Reuters, noting that it is being reimbursed by insurance in a growing number of markets

Acomplia, generic name rimonabant, suffered a new setback on March 4th when the social court in Berlin-Brandenburg upheld a previous court ruling that German patients taking Sanofi-Aventis’s diet drug will not be reimbursed by their health insurers.

While Acomplia has been approved for sale in the European Union for almost two years, sales have been disappointing, in part because Germany’s joint healthcare committee October 2006 classified it as a “lifestyle” drug and ruled that the country’s health insurance scheme did not have to reimburse its cost.

Sanofi, which had argued that Acomplia should be covered under the state health insurance program because it also helps lower the risk of developing diabetes and heart disease, said it was evaluating its legal options.

But with this latest decision confirming an earlier court ruling in June 2007, which Sanofi had appealed, the French drugmaker would no longer appear to much hope of overturning the German decision.