Consumers awaiting the latest weight loss pill will have to wait at least three more months.
The Food and Drug Administration has delayed a decision that was expected Wednesday on the prescription medication Contrave, drugmaker Orexigen Therapeutics Inc. announced.
If approved in September, the drug will be the third new prescription weight loss aid in about two years, joining Qsymia, from Vivus Inc. and Belviq, from Arena Pharmaceuticals Inc. and Eisai Co.
The delay is needed to finalize an agreement on tracking cardiovascular safety after approval, the company said. The company already has submitted interim cardiovascular data from an ongoing study of 8,900 patients — which the FDA requested after it rejected Contrave in 2011.
Those data show no increased heart risks, the company has previously reported.
"We are working expeditiously with the FDA to finalize the review," Orexigen's CEO Michael Narachi said in a press release.
A much larger Japanese company, Takeda Pharmaceutical Co., would market the pill in the United States.
While it might seem surprising in a country with a huge weight problem, the biggest question surrounding Contrave and its recently approved competitors is whether any of them will ever catch on.
The medications have been slow starters, doctors say. Reasons include costs, low levels of insurance coverage and lingering concerns about the safety of any weight loss drug. Doctors also have other prescribing options, including a cheaper, older drug called phentermine. Patients can get a low-dose version of another medication, Orlistat, in the over-the-counter Alli.
Doctors have not forgotten about safety problems surrounding some past weight loss drugs and patients haven't heard much yet about the new drugs, says Donna Ryan, an obesity researcher and professor emerita at Pennington Biomedical Research Center, Baton Rouge.
But, she says, many patients could benefit from new medications. "Patients need help, Patients are struggling to lose weight on their own. It's not just a matter of eating a little bit less and exercising a little bit more."
Ryan, who has consulted for companies including Vivus, Eisai and Takeda, says the delay from FDA on the latest contender "is not a negative signal, it's a sign that officials at the FDA are taking the review seriously — as they should."