Acomplia (Rimonabant)

Acomplia is a drug with rimonabant as an active ingredient. They have a form of teardrop of white color. This medicine is manufactured to cure together with exercises and diets the patients who are overweight.

People who have BMI (body mass index) equal to or more than 30kg/m2 or those that have BMI equal to or more than 27 kg/m2. Also, those that are under other factor of risk, with diseases like dyslipidemia (when a person in his blood has huge levels of fat) and with diabetes of second type. This drug you can buy only if you have a prescription from a doctor.

One tablet of Acomplia should be taken before your breakfast once a day. The diet with reduced calorie meal should be followed and you need to do more physical activities. Those patients that have difficulties with their kidney or liver should stay away from using this medicine.

Acomplia has an active substance which is called rimonabant. This element is an antagonist of cannabinoid receptor. It blocks specific receptors that are situated in nervous system, that our organism uses to maintain how much food do we take. This receptors are called CB1 (cannabinoid type 1) receptors. Our body's fat tissue (adipocyte) has also these receptors.

First studies of Acomplia effects were made on experimental models. Later, it was tested on people. 7000 of obese and overweight men and women with a weight from 94 to 104 kilograms were tested with Acomplia by four studies. One of the studies carefully examined those patients that had diabetes of type 2. Another study was observing particularly patients whose blood fat levels are not normal. The investigations tried to compare Acomplia effect with a simple placebo. The studies on weight loss had lasted more than one or two years.

The second year of how the body behaves and loses its weight was observed by one of the studies. Another four researches were made with Acomplia on how it helps a person to stop smoking. Another 7000 people were studied using this drug and compared it with placebo. During these studies they measured how the medicine effects a person, if he uses it during 10 weeks. They examined how peopled stopped smoking and how it effected on the repeating the next year.


Uses

Obesity
Obesity
 
Acomplia was developed to treat people who are obese and overweight using in addition physical exercises and diets. Patients, that are sick with huge levels of fat in their blood and diabetes of 2nd type.

Acomplia was also persuaded by Sanofy as a disease that can stop the beginning of cardiovascular disease. People that have a huge waist (88 cm women and 102 cm men) were promised to get a big advantage from using this medicine.

Quitting smoking


Quitting smoking
Quitting smoking
 
It was proved that Rimonabant can help people who smoke to stop smoking. Right now, Sanofi-Aventis is making researches to prove that rimonabant is a possible treatment for smoking-cessation. STRATUS program (Studies with Rimonabant and Tobacco Use) has more subjects than 6,000. This program explores two therapies that are related to smoking. First one is to help a smoker to quit. The second program is to prevent a quitter gain weight.

Evidently the first results showed that rimonabant is efficient for both therapies. Sanofi-Aventis had received a clear explanation from FDA that they will not allow him to sell rimonabant in United States as a smoke-cessation medication without any supplementary studies. A 2007 review by Cochrane had showed that rimonabant can help to quit smoking with the odds of about 11/2-fold.

Dependency


Rimonabant decreases the act of beginning again of responses for seeking cocaine that are initiated by 2 out of 3 most usual activators of relapse that humans have. They are cue and priming. It is also able to reduce the behavior of seeking opiate and ethanol.

Remembrance


Tetrahydrocannabinol is a reagent that decreases your short memory. There was a hypothesis that rimonabant can make the short-term memory much better. Suring animal studies, rats showed an amazing result by encoding the information in their memory that is of a short term.


Dosage

Acomplia 20mg
Acomplia 20mg
 
Two doses of 10 mg and 20 mg of Acomplia are very typical. This amount of Acomplia is usually chosen by people that want to start a daily treatment of this drug.

Accompllia is not very difficult to use. The pill of Acomplia should be taken before breakfast each day in the morning. You can drink it with a cup of water. It is important to remember each time you take it and don't forget and take another dose on the same day.

Talk to your physician about taking another medicine at the same time. Mixing two medicines can bring discomfort to your health. The drug can bring some effects that you wouldn't like. Consult your physician about the dosage and about any possible limitations considering your health condition and your body background.


Warnings and Precautions

Hard depression
Hard depression
 
In October 2008, Acomplia pills had lost their license all over the Europe. The medicine gave risks that exaggerate the benefits of using it. It was identified that Acomplia has the most dangerous side effect, which were problems with mental disorders. Usually it was a hard depression. The analysis that was made recently showed that the risk of this disease is much bigger than it was initially stated. Studies showed that if you compare two cases of using Acomplia and using placebo, the risk of having a psychiatric problem is two times higher for Acomplia than for another one.

After the product was manufactured and launched to the market, some clinical advices and measures were implemented. They still didn't decrease the risk and the frequency of these effects. Some assessments of European professors showed that no limitations could decrease the risk of having problems. After that, the product was taken away from the European markets. You should talk to your doctor when it is convenient for you, if you are using Acomplia and discuss the cure. Anyway, you can finish taking Acomplia any time you want.

During clinical trials it was established that those patients who are continuing the treatment are loosing weight. Those, that had stopped treatment, immediately have almost the half of weight back, after quitting. You need to remember to keep a diet and do exercises when during your treatment and after it. It will assist you loosing more of your weight. Effectiveness and safety was not studied to those who have taken the medicine for more than two years. Acomplia can bring you permanent mood swings and depression symptoms. You should consult your doctor immediately and stop taking the drug, if you noticed that you are not satisfied with your life or having mournful feelings and thought.


Side Effects

Acomplia was studied in America for two years. They discovered such side effects like the condition of being depressed, irritated and anxious all the time. The continued use of this drug brought dangerous side effects. That is why FDA had never approved it.

Acomplia was approved by EU in 2006. Later, they took it off the market because there were occasions reported of strong problems with state of mind, even the state of committing suicide.

People that used Acomplia had reported for some other side effects:
  • High pressure of blood
  • A state of intense apprehension and worry
  • Inability to fall asleep
  • Usual depression
  • Petulance
  • Disgust
  • Emetic



Mechanism of action

Rimonabant formula
Rimonabant formula
 
The pills of Acomplia have an ingredient that is very active. Its name is rimonabant. This type of drug is called cannabinoid-1 receptor antagonist. Usually people who are too overweight and obese use it to loose weight. The active ingredient blocks CB1 receptors, named cannabinoid-1 receptors. They are usually situated in digestive system, muscles, fat tissue, liver and brain.

An endocannabinoid system of human's organism contains these CB1 receptors. Actually this system was discovered and investigated not so much time ago. It takes part during regulation of body weight, energy balance and fat and sugar metabolism.

Cannabinoid-1 receptors are situated in a special part of our brain which is named mesolimbic system. It takes part to decide when we eat fatty, tasty and sweet foods. When CB1 receptors become very active, the fat build-up, appetite and desire for eating increase.

Rimonabant helps to stop desire for harmful food and helps you to control this feeling and decrease your appetite by blocking CB1 receptors.

This solution can also rise up the level of blood of HDL - cholesterol that are "good fats" and diminish the blood level of triglyceride also called as "bad fats".

Obesity is a condition when the body receives more food energy than it needs according to the quantity of performed physical exercises. So, reducing the desire for food and constant hunger is a little piece of the whole weight loss process. The other main details of this process when you are taking medicine are exercise activity and diet with reduced calories. Your doctor should know everything about it, so do not hesitate to ask him.


History

In May 1999, Sanofi-Aventis had submitted an application of investigational new drug for rimonabant to the Division of Metabolism and Endocrinology Products.

Acomplia history
Acomplia history
 
In April 2005 a New Drug Application for rimonabant was forwarded to DMEP. They wanted the dose of 20 mg per day of rimonabant to be approved for loose of weight. This dose is enough for the maintenance of weight and weight management for people that have one of the risky diseases like diabetes of type 2 or hypertension and those that have a BMI from 27 to 30 kg/m2. Sanofi-Aventis asked also to approve rimonabant as a cure for dyslipidemia, metabolic syndrome or diabetes of 2nd type.

13,011 patients and subjects from 36 studies of Phase 1, 5 studies of Phase 2, that contained 1 study of preventing alcohol individuals to relapse into detoxification, two studies in risk of gaining weight after loosing it, 1 study of treating schizophrenia, and one study when quitting smoking. The third Phase had eight studies and included 4 studies in quitting smoking and four studies in weight management. All of this data were included by NDA.

Information from 4 studies from Phase 3 was submitted to substantiate requested symptoms. All of them were named RIO, which stands for Riomonabant in obesity. So, there are Rio Lipids, RIO Europe and RIO Diabetes. They investigated two doses during studies. Doses of 5 mg and 20 mg that were taken one time a day.

DMEP made a conclusion according to the active data from RIO researches, that 20mg dose is more effective to manage weight than 5mg dose. It was unbelievable for some reasons, so they wanted to make more tests concerning how the drug affects people with dyslipidemia, metabolic syndrome or diabetes of second type.

Besides, clinical and preclinical data were reviewed to raise a question how rimonabant associates with seldom occasions of negative psychiatric events, like tending toward suicide, an amount of sick neurological symptoms and signs and seizures.

In February, 2006 DMEP have sent an approvable letter to Sanofi-Aventis according these issues. They asked to prove by researches and data that this drug does not provoke any adverse events that are potentially related.

In October 2006, Sanofi-Aventis provided all the necessary analysis and data which are making the origin of this instructive document.

Rimonabant was taken away from the world wide market by Sanofi-Aventis. This drug is not developed any more. In January, 2009 European Medicines Agency also forbad to sell Acomplia. They did it because this drug brings risk of psychological perilous side effects such as the condition to commit suicide. It was also taken away from the market of United Kingdom in 2008. They thought that the risks of using this drug are more than its benefits. Metabolic and Drugs Advisory Committee together with Endocrine of FDA had voted against Rimpnabant, that in US had a name of Zimulti, in the middle of 2007. There were some issues concerning its side effects that were too dangerous. Rimonabant was never on the US market because FDA didn't give their approval.


Generic Acomplia

As of 2007 the trade name of Acomplia was applied in 18 countries. Sanofi-Aventis were selling rimonabant in America and Sanofi-Synthelabo sold it in Denmark. Pharmacies in India sell generic forms of Acomplia with a name Remonabent, Rimoslim, Monaslim, Riobant and Bethin. They intend to sell it in America under name Zimulti, if it will be approved.

General keywords

User discussion about Acomplia

Linda
16 April 2012
If this drug was taken away from the world wide market, why are you writing about it? I don't think that all people read drug instructions to the end, and it may happen that somebody can start taking it. I don't think it's a good idea to give instructions of uses and dosage of the drug that was prohibited.
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