Contrave Given a Second Chance
Contrave, a proposed prescription drug to enhance weight reduction has been given a new chance for approval by the FDA.
Contrave is a combination of naltrexone , which is an opiod receptor antagonist used primarily for alcohol and opiate dependence, and bupropian, which is commonly known for its effectiveness in smoking cessation and as an anti-depressant. This combination targets behavior and reward pathways in the brain. The drug is being developed and tested by the company Orexigen.
One of the benefits Orexigen has claimed and proven to the FDA is that Contrave possesses the ability to help obesity and sustain weight loss of 5% of body weight within a year of beginning use. This is one of the FDA’s requirements for an approved, prescribed weight loss drug.
Contrave is the third of three obesity drugs to be denied approval by the FDA this year, but Orexigen has been given a second chance to prove that the benefits outweigh the risks. The other two drugs to be rejected are Qnexa (proposed by Vivus) and Lorcarsin (proposed by Arena Pharmaceuticals). All three were denied approval due to safety issues.
The most concerning of the side effects of the proposed Contrave are elevated high blood pressure and heart pulse rate which would be most prominent during the first three months of use. This leads to concerns for cardiovascular health. Other side effects include nausea, vomiting, and diarrhea.
Originally, the FDA’s position demanded cardiovascular outcome trials/studies that would possibly take four to six years, require immense financial commitment, and involve 60,000-100,000 participants. The requirement has now been adjusted to trials involving less than 10,000 subjects using randomized, double blinded, and placebo controlled elements ( including patients with a BMI of ≥ 27 kg/m2 when accompanied by co-morbid conditions, i.e. type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, CVD. The trial could potentially be completed by the year 2014 and is scheduled to begin by the start of 2012.
The FDA said in Tuesday’s press release that the studies on the exploratory drug must show the exclusion of unacceptable risks for cardiovascular side effects.
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