Despite an advisory panel recommendation late last year, Orexigen’s weight-loss drug Contrave has been unexpectedly rejected by the FDA. However, the agency agreed with the panel about a need for more heart-safety studies.
“We are surprised and extremely disappointed with the agency’s request in light of the extensive discussion and resulting vote on this topic at the Dec. 7 advisory committee meeting,” Orexigen’s President and CEO Michael Narachi told the press.
Although the company is hopeful that Contrave will eventually gain FDA approval, their chagrin stems from the fact that more clinical trials will likely take several years and cost millions of dollars to complete.
This is the third diet drug rejected by the FDA in the last year, leaving Xenical as the only long-term prescription weight-loss medication on the market.
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