Very disappointing news for the millions of obese Americans as the FDA rejects weight loss drug Contrave, insisting on an extensive cardiovascular study.
Hopes had been high that the FDA would give Contrave the green light after it got the thumbs up from the endocrinology advisory committee in a 13-7 vote back in December. During clinical trials, small increases in blood pressure and heart rates were observed, both of which ring alarm bells when it comes to cardiovascular safety. It had been suggested by the advisory committee that a post -marketing study would be a sensible way to glean observations relating to cardiovascular safety that might affect the risk/benefit profile of Contrave, which is already pretty close to the threshold that qualifies a weight loss drug for approval.
All of this is very disappointing for Orexigen, the drug company behind Contrave. Although it has $150 million in the bank and another weight loss drug candidate making progress, the bill for an extensive additional clinical trial may be enough to sink Contrave. We expect to hear more from the company in the coming days as its share price takes a battering on the New York Stock Exchange.