Weight Loss Medicine and Prescriptions - Contrave
Contrave is an investigational medication for the treatment of obesity believed to have a unique mechanism of action that works at two levels within the central nervous system: one associated with controlling the balance of food intake and metabolism and another involved in controlling food preference, reward and cravings. We believe that Contrave has the potential to be the first treatment for obesity to target both of these reward centers in the central nervous system. Contrave is believed to initiate and sustain significant weight loss over one year of treatment by reducing appetite, increasing metabolism and allowing the body to continue losing weight by offsetting its natural tendency to fight back and slow down the weight loss process.
Orexigen reported the results of the COR-BMOD (NB-302) trial in January 2009. This was a 56-week trial designed to assess the safety, tolerability and efficacy of Contrave32 versus placebo in 793 obese patients combined with an underlying intensive behavior modification regimen. The trial was conducted at nine U.S. centers. Patients in that trial who completed one year of treatment on Contrave lost 11.5% of their body weight, compared to 7.3% on placebo.
ADVERSE REACTIONS
As with all medications, some side effects were noted but they seemed to be very rare. The most serious side effects to be reported were gall bladder infection and seizures. These side effects affected two patients each. One patient had heart palpitations, another had poor circulation and one had suffered from vertigo. The most common side effects included nausea, constipation and headaches
About Orexigen(R) Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead investigational product, Contrave, has completed Phase 3 clinical trials and is on track for a regulatory submission with the FDA in the first half of 2010. The Company's second product, Empatic(TM), is in the later stages of Phase 2 clinical development, with results expected in the second half of 2009. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found at
Source: http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID=1308...
Effectiveness compared with current drugs?
In January 2009, disappointing results were released from late stage clinical trials where patients taking the weight loss drug lost only 4.2% more body weight than those taking the placebo. 66% of patients taking Contrave lost at least 5% of their body weight, compared with 42% taking the placebo. The FDA regulations state that for a weight loss medication to be considered, there must be at least a 5% difference achieved by the groups taking the medication or patients who lose 5% while taking the active ingredient must be at least double the number who lose the same percentage of weight on the placebo.
Orexigen say that they were expecting results like this as they ensured that all patients taking part in the trial also took part in a behavior modification program, so the group on the placebo lost more weight than would ordinarily be expected.
Results announced in July 2009 showed much more promising results, meeting at least one of the FDA benchmarks. There were two 56 weeks long non-diabetes trials and in these programs 48% and 56.3% lost at least 5% of their body weight against 16.4% and 17.1% in on the placebo. In the diabetes trial 44.5% lost 5% of their body weight compared with 18.9% on the placebo. There was also a statistically significant reduction in blood sugar levels of 0.6% against 0.1% on the placebo.
Source: http://www.theonlineclinic.co.uk/Contrave.asp
Dosage
As per the trials it is found that a single pill of Contrave containing the proper doses would be easier for patients, but insurers could refuse to pay for Contrave, if it is much more expensive than the combined price of its two components.
Sources:
http://www.nytimes.com/2009/10/17/business/17obesitybar.html
http://okezonee.blogspot.com/2009/07/orexigen-says-contrave-obesity-tria...
http://www.diet-blog.com/06/contrave_another_weight_loss_drug.php
Where to buy from
Following the announcement of the successful clinical trial in January, it is expected that Orexigen will put forward a new drug application for consideration in 2010. Until Contrave has been approved, it will not be available to purchase or prescribe.
Who is eligible for the new drug
As per the clinical trials held, Obese male and female volunteers, ages 18–65 years, with BMI 30–45 kg/m2. Eligible patients were nonsmokers who could abstain from alcohol during the study, and were not undergoing or in need of treatment for any chronic disease, with the exception that stable treatment for hypertension and/or dyslipidemia was permitted. Physical exam, routine laboratory tests, and electrocardiogram had no clinically significant abnormalities at screening.
Apart from this Diabetes patients were also included in the trial periods
Source:
http://www.fiercebiotech.com/press-releases/orexigen-r-therapeutics-anno...
http://www.news-medical.net/news/20100628/Orexigen-Therapeutics-announce...
Cost, will it be paid by insurance?
The exact cost of Qnexa is not known. Also unknown is whether insurance plans will cover this drug or not
