FDA Rejected First Approval Try
The FDA rejected Vivus' first petition for the drug's approval in October 2010, citing, among other things, concerns that the medication increased the risk of heart attack and stroke.
That same month, the agency also failed to approve Belviq and forced the removal of the weight loss drug Meridia from the market because of concerns of an increased risk of heart disease and stroke.
The approval of two new drugs in just a few weeks signals recognition by federal officials that new weapons are needed in the battle against obesity, says W. Timothy Garvey, who chairs the department of nutrition sciences the University of Alabama at Birmingham.
Garvey was a lead researcher in the Qsymia studies.
Qsymia Users Lost 10% of Weight
Patients in those trials who took Qsymia and made lifestyle changes lost an average of about 10% of their body weight after one year on the drug, compared to a 2% weight loss in people who took placebo pills.
Although this loss is considered modest, it was still about twice as much as was reported in trials of Belviq and some other weight loss drugs.
Side effects included constipation, dry mouth, and tingling in the fingers and toes, but Garvey says there was no evidence of an increase in heart disease or stroke risk.
He adds that people with diabetes or those at high risk for developing diabetes may benefit most from taking the drug.
In the company-sponsored studies, these patients showed improvements in blood sugar control, along with weight loss.
"We haven't had a new drug for obesity in over a decade," Garvey says. "These drugs help fill this void."
Safety Concerns Remain, Critic Says
But critics counter that people who take the drugs may be taking a risk.
"In the case of (Qsymia), this is the second time that a company has sought to combine (the stimulant) phentermine with another drug," says Sidney Wolfe, PhD, who is director of health research for the consumer group Public Citizen. "The first time was fen-phen."
At the height of its popularity in the 1996, 18 million prescriptions were written for the combination of fenfluramine and phentermine, or fen-phen.
Fenfluramine was taken off the market after being linked to potentially serious heart valve problems in as many as 1 in 3 users.
"These (new) drugs were approved because patients and doctors are desperate," he says.
The medication will be available by the fourth quarter of this year, but the price is not being released yet, according to media reports.