Orexigen Therapeutics Inc. is trying to revive a previously abandoned weight loss drug called Contrave. The company said on Thursday that federal health officials outlined a plan that could bring the drug to market by 2014, reports the AP.
In February, the FDA rejected Contrave because of concerns that the drug could increase heart problems. Two other experimental weight loss drugs were rejected last year as well.
Then, in June, Orexigen said it would not seek U.S. approval for the highly anticipated pill because of the government’s “unprecedented” demands for additional safety studies.
However, now the Food and Drug Administration has agreed to a study which could be completed and reviewed by 2014. The development puts Contrave back in the race to be the first new prescription weight loss drug to reach the U.S. market in more than a decade.
The study proposed by the FDA would involve 10,000 patients and take two years to gather the necessary data on heart side effects.
Orexigen said in a statement to the AP, “Orexigen believes that these design requirements are reasonable and feasible and provide the certainty required to reinitiate development of Contrave.”
Meanwhile, CEO Michael Narachi attributed the FDA’s change of heart to efforts by patient groups, lawmakers and the company itself, telling the AP, “I think this was a multi-pronged effort that we built to create some momentum that helped the process.”
Safety risks, including heart side effects, have been the main concern for weight loss drugs, though Contrave may be the safest of the new generation of obesity treatments because it combines two older, established drugs: an antidepressant and an anti-addiction drug to curb appetite.