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A new drug, Belviq, is the first new prescription drug for long-term weight loss to be entered into the U.S. market in over a decade after The Food and Drug Administration approved the Arena Pharmaceutical’s anti-obesity pill.
Although the drug only achieved moderate weight loss during clinical trials, the drug appeared to be safe enough for the FDA to approve and endorse the new pill.
With diabetes or high cholesterol being a medical complication for the new pill, the agency cleared the new medication on Wednesday for adults whom are obese or over weight.
In 2010, the FDA denied approval for the Arena’s drug after scientists raised concerns about tumors that had developed in the animals studied with the drug.
After the company resubmitted the drug with additional data early this year, the FDA claimed that there was little risk of tumors in humans.
With the U.S. obesity rate nearly 35 percent of the adult population, the FDA has been called to approve new weight loss methods.
However, a long line of weight loss prescriptions were associated with safety problems such as the fen-phen combination in 1997 that was linked to heart valve damage.
In a rare move by the FDA, they explained in a press release the Belviq “does not appear to activate” the chemical pathway that was associated with the heart problems found with fen-phen.
It is stated that the drug focuses on a different chemical pathway located in the brain. The pathway targeted controls the feeling of fullness and is believed to reduce appetite.
Belviq is a weight loss pill that is one of three experimental drugs whose developers are currently trying for a second time to win approval after being shot down by the FDA in 2010 due to potential of serious side-effects.
Vivus Inc.’s Qnexa is thought to be a more effective of the drugs while achieving the most weight loss, however, the FDA has delayed making a decision until July.
Shares of the San Diego-based Arena Pharmaceuticals Inc. jumped $3.03, or 34 percent to $11.88 in trading on Wednesday.
Studies show that on average, patients taking Belviq, lost merely 3 to 3.7 percent of their starting body weight over an entire year.
Medical side effects of the drug include depression, migraines and memory lapses.
In May, a panel voted 18-4 in the recommended approval of the new drug concluding that its benefits outweigh the risks.
While there are still several others drugs available for attention on short-term weight loss, until Wednesday, there was only on FDA-approved drug for long-term weight loss Xencial from Roche, which is rarely prescribed due to the unpleasant digestive side effects associated with it.
According to experts, the challenge of weight loss drug development occurs when dealing with the safety of being able to turn off one’s body’s fundamental directives: to eat enough food to maintain its current weight.