FDA rejects approval for weight-loss drug, Contrave.FDA ruled Orexigen Therapeutics Inc. to keep away the weight-loss drug, Contrave from the market. The agency made this step to avoid possible cardiovascular problems in users. Earlier the agency had given permission to sell the drug across the country. FDA has already banned the sales of anti-obesity drugs like Qnexa and Lorcaserin.
In its official statement to the drug manufacturer, FDA has mentioned the reason for such a quick decision. The agency agreed that the Contrave have helped 50% of patients to cut 5% of their body weight in clinical trials. But it raised the question of 10% user those experiencing heart risks. Giving the concern of patients more priority, the agency asked to conduct more research on the side effects of the drug.
There were reports claiming that Contrave users felt slight increase in blood pressure and pulse rates. Now the company has to do more clinical researches to prove the security of the drug. According to industry experts such a trial would probably take three to five years and cost as much as $200 million.
The latest market reports never support Orexigen to bear such a big budget for research. The FDA move has hit company’s stock falling 73%. Earlier, market analysts had predicted $1.2 billion sales for Contrave by 2018.
Meanwhile, Orexigen officials expressed their disappointment over the striking move from FDA. FDA advisory panel had voted 13 to 7 in favor of approving Contrave back in December. The agency defended its decision asking to address the cardiovascular problems via post-marketing study. But, now the agency has rejected its own approval for Contrave.
Contrave is a combination of two drugs: naltrexone and bupropion. The first one is served to combat alcohol and drug addiction while the later is antidepressant known as Wellbutrin.