Efficacy and Side Effects
Orexigen claimed (3 years ago) that after the Phase II Contrave experiments the participants showed a fifty percent reduction in metabolic syndrome, which is a bunch of dysfunctions that rise the risks of spreading cardiovascular deseases, incl. high blood pressure and insulin level, overweight close to the waist zone, etc. Such factors might develop diabetes and other hormone related dysfunctions.
After the 6 month Contrave experiments in treatment of overweight it was found out that of the one third patients possessing metabolic syndrome, a half of them got rid of it. The placebo participants had also a little reduction, but not so evident.
Contrave (aka Bupropion Naltrexone) operates in the brain zone where the human’s appetite is controlled. Some participants have experienced significant weight reduction with only one component, Bupropion, but the combination of two drugs showed really incredible benefits of treatment, despite that bupropion as a drug has not been accredited by the Food and Drugs Administration to be given as a weightloss medication.
In experiments with combinations like placebo/naltrexone or placebo/bupropion, Contrave (naltrexone/bupropion) outweighted both. The clinical experiments have demonstrated Contrave’s efficacy especially the phase III experiments in which more than 4600 participants were going thru the FDA efficacy standard to prove the significance of weight loss.
At the average, the patients dropped between nine to fifteen percent of the body weight (in combination with the general testing containing some diet and exercise prescriptions). These numbers were much more significant than those in patients from the placebo division.
But the positive numbers were also conjuncted with the adverse reactions for some of the patients. Some of the potential adverse reactions in Contrave are nausea, headaches of mild to moderate effect.
This, however, does not automatically make Contrave an approved drug, because the Food and Drug Administration is going to weight a lot of various factors in order to make the final decision on Contrave. Some general FDA concerns are cardiovascular and high blood pressure risks, and psychological factors like depression.
The final decision on Contrave will be made on December, 7. After the decision we either will be able to buy Contrave online or not.
The Naltrexone/Bupropion Trial
One of the drugs for weight loss by Orexigen Therapeutics Inc. that is being tried by FDA will be retailed under brand name Contrave in case of approval. The most interesting fact about it is that the medication actually compises the two approved and retailed medications for other treatments.
These approved drugs are the Wellbutrin, a drug used to treat depression (aka Bupropion; additionally used for tobacco addiction). The other Contrave substance is a medication utilized for the patients addicted to alcohol or drugs; known under brandname Revia (aka Vivitrol, Naltrexone).
During Stage II of Contrave experiments various dosages where tested in once-a-day formula. The dosages included 16 mg, 32 mg or 48 mg Naltrexone (Immediate Release) with 400 mg Wellbutrin (Sustained Release) in each case.
The 32 mg Vivitrol (IR) + 400 mg Wellbutrin (SR) combination showed the minimal risk level in most cases putting it into a primary position.
However, it is worth saying that currently Contrave is undergoing Stage III trials, and it seems that the one that is going to pass the tests is a SR/SR combination which is believed to be more tolerable.
Still there is no foggy idea whether the drugs will be approved by FDA. Time will show whether we will be able to buy Contrave or not.
