New fat pill is back
Contrave, made by Orexigen Therapeutics, includes an appetite suppressant and a component to prevent addiction.
A US Food and Drugs Administration committee recommended late on Tuesday (7 December 2010) it should be approved, despite concerns about its effect on the heart.
Contrave, which is being developed with Takeda Pharmaceutical, a Japanese company, is heading for approval as Britain grapples with its overweight population.
Patients taking Contrave experienced relatively modest weight loss, with about 35% losing at least 5% of their weight.
One member of the committee said that rejection of its licence might deter other companies from developing weight-loss treatments.
Abraham Thomas, chairman of the panel, said: "My concern is... we will potentially kill development of these medications, and it is the most serious disease the United States is facing."
The experts voted 13-7 to back approval of Contrave, but advised a larger clinical study to look at potential heart risks.
Contrave combines Naltrexone, a drug to treat alcohol and drug addiction, with the antidepressant Bupropion, better known as Wellbutrin, in an attempt to boost the metabolism while curbing appetite and cravings.
There was a slight increase in blood pressure and pulse rates for Contrave patients compared with those given a placebo in clinical trials.
In October, the FDA rejected two rival weight-loss pills, made by Arena Pharmaceuticals and Vivus.
Vivus's shares rose by 16% to $9.02 last week. Arena's added 15% to $1.62.
Source: Sunday Times
Source: I-Net Bridge
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