Contrave® is a unique mixture of two already existing medications for the treatment of obesity created by Orexigen Therapeutics Inc, a pharmaceutical company based out of California. The combination is made from naltrexone IR and bupropion SR. (IR: Immediate Release, SR: Sustained Release). The drug naltrexone is better known to most as the trademarked names Revia® or Vivitrol®. Bupropion is also well known under its trademarked names of Wellbutrin® or Zyban®.
Naltrexone is typically used for drug addition, including common street drugs as well as alcohol. Naltrexone is an opiate antagonist, which blocks the effects of opioid drugs (opioid receptors in the brain). However does not prevent withdrawal symptoms associated with quitting these drugs. Some of the common side effects that have been reported with Naltrexone have been nausea, constipation, loss of appetite, headaches, anxiety, irritability etc.
Bupropion an atypical antidepressant that was later found to be a good smoking cessation drug. Bupropion does not work in the way that SSRI's work. SSRI stands for Selective Serotonin Reuptake Inhibitor where as Bupropion is a Norepinephrine-dopamine reuptake inhibitor. Some of the benefits of Bupropion being used as an anti-depressant are that it is not associated with either sexual dysfunction or weight gain like many common SSRI's. Infact Bupropion has been known to help people lose weight. Another benefit of Bupropion is that it may be able to be combined with an existing SSRI anti-depressant. As a result Contrave, under a doctors supervision, may be able to still be taken with an SSRI anti-depressant. One concern with Bupropion has been an increased chance of seizure but chances are still very low. But specific amounts of each combined create an effective weight loss concoction that has been looked favorably upon by the FDA. Bupropion has shown weight loss abilities by itself but has only ever been prescribed off label for such and the combination of the two medications is responsible for significantly more weight loss.
While it is common to believe that diet pills work in ones stomach Contrave works in ones brain, more specifically the hypothalamus which is the bodies central control center responsible for monitoring issues like temperature, energy output and ones appetite.
Clinical testing of Contrave helped many patients achieve weight loss upwards of 15% of their body weight. While that number does not necessarily describe each person's experience while taking Contrave, the overall effects on weight loss have been proven over years of time and on thousands of obese patients. On average the placebo adjusted weight loss was around 5%. As is the case with medications there are side effects that have been reported but generally these where considered mild to moderate which included headaches, nausea, and constipation. There where also some slight issues reported with raised blood pressure and possible cardiovascular issues. But these issues will be studied in longer term tests post approval of Contrave to ensure a safe product.
Another positive on Contrave's side is that this medication did not show any negative traits regarding increased depression that has been a factor in previously tested obesity drugs. A few years ago there was testing for a drug named Rimonabant that actually was passed in Europe as a diet pill but was later retracted due to psychological damage. Perhaps this could easily be explained due in part to the ingredient bupropion which is often used as an anti-depressant. Still another question that remains to be seen is if Contrave would help the obese who are suffering from depression and or drug addiction. Contrave has also been shown to be a positive factor for people suffering from type 2 diabetes.
Typically a drug prescribed for obesity comes with the recommendation to partake in a doctor recommended amount of exercise and a better diet. Contrave is not any different in this department. While Contrave in most would produce weight loss without major changes, to have the full effect it is recommended to most to follow an overall health plan as pointed out by ones physician. Contrave once available will be a medication only available via prescription from a medical doctor. In order to have this prescribed to you, you will have to have a body mass index count that points to you being overweight / obese unless a doctor says otherwise. Only ever take Contrave as prescribed by a medical health care professional and always talk to your doctor about a diet and exercise plan that would be right for you. Also never attempt to mix these two medications together and take the resulting mixture. The attempt to create this on your own could prove to be very dangerous. Contrave is a specific mixture with specific release formulations. Only take as recommended.
The FDA official vote date on Contrave is proposed for January 31st 2011. It is most likely that they will vote Yes for the approval of it due to the December 7th vote where FDA panel members voted in favor of approval in a 13-7 vote.
Frequently Asked Questions
Q: What are the specific ingredient amounts in Contrave?
A: According to phase two testing the following amounts were used:
(16 mg naltrexone *IR - 400 mg bupropion *SR)
(32 mg naltrexone *IR - 400 mg bupropion *SR)
(48 mg naltrexone *IR - 400 mg bupropion *SR)
*IR= Immediate Release
However it was the 32mg naltrexone IR with 400mg of bupropion SR amounts that had the optimum benefit to risk ratio which made this amount the favorite.
Stage 3 trials has an Orexigen created Naltrexone SR which makes the drug more acceptable. Thus making Contrave's both ingredients sustained released.
Contrave® = Naltrexone*SR + Bupropion*SR
Q: Where can I buy Contrave?
A: There is not a place where you can buy Contrave at this time. It has yet to be placed on the market. Stay tuned to this site for news updates regarding this.
Q: What does Contrave Cost?
A: Currently it cannot be purchased as it has not been officially accepted but the target price of Contrave looks to be around the $5 a day mark.
Q: Will I have to change my lifestyle along with taking Contrave?
A: A proper diet and exercise would be encouraged while taking Contrave. While it may not be necessary in order to lose weight with Contrave, it is always beneficial to do what is possible to encourage weight loss and improve ones health. Talk to your doctor.
Q: What is the company's stock symbol who makes Contrave?
A: The company is Orexigen Therapeutics, their stock symbol is: OREX
Feb 22nd, 2012
Qnexa, another proposed medication to treat obesity has been given a 20-2 Yes vote by the FDA advisory panel committee.
Feb 6th, 2012.
The FDA and Orexigen Therapeutics Inc have reached an agreement on the protocol of its cardiovascular safety trial with Contrave. Orexigen is now ready to start the safety trial later in the 2nd quarter of this year. There will be approximately 10,000 patients in placebo controlled tests. The goal is to prove that Contrave does not increase the risk of major cardiovascular issues beyond what is considered safe. The earliest that Contrave could be obtain FDA approval would be 2014.
Sept 20th, 2011.
There has been renewed hope for Contrave in the fight against obesity. Today Orexigen announced that it will be returning to development of its anti-obesity drug Contrave after the FDA outlined a new plan that could have it approved by 2014. Previously Orexigen thought the FDA's addition required safety study where unprecedented and unrealistic. The newly outlined plan would consist of less than 10,000 patients and take around two years to complete. The testing trials are expected to start in 2012 and where they will mainly test Contrave's effects on the heart and cardiovascular issues. As a result Orexigen stated that these where "reasonable and feasible" and are quit optimistic that Contrave will ultimately pass these tests.
June 3rd, 2011.
Orexigen Therapeutics has announced that due to what it feels are unprecedented demands about safety issues for Contrave it has put this obesity medication on hold, thus halting further development for now. Orexigen however has decided to appeal the FDA's decision as they feel the FDA's demands are unprecedented and unwarranted. Perhaps what may be a glimmer of hope is that the FDA plans on holding an advisory committee regarding cardiovascular risk issues for obesity medications in early 2012. This perhaps could change agreements about cardiovascular studies depending on what this meeting brings about. Orexigen is also open to the idea of non-US markets to market its drug Contrave.
April 4th, 2011.
Orexigen released news today from their late stage study showing that patients taking Contrave maintained normal blood pressure during a year of treatment. Contrave did not show any affect on blood pressure either negative or positive. Blood pressure patterns around the clock where consistent and did not appear to be affected by Contrave. These studies also showed that there where improvements in cholesterol levels.
February 1st, 2011.
The FDA did not approve Contrave. Before any approval will take place Orexigen must first perform further studies to ensure that the diet drug does not raise the risk of heart attacks. This along with Lorcaserin and Qnexa is the 3rd diet drug this year to be rejected.
Contrave® is a new fda panel recommended prescription diet pill