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FDA approves weight-loss drug

23rd July 2012

The US drug agency has approved a second weight-loss drug for the treatment of obesity in people who are already on a calorie-reduced diet and exercise programme.

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The Food and Drug Administration (FDA) approved Qsymia, a combination of two drugs: phentermine and topiramate, for use in patients with chronic weight-control problems who also have at least one weight-related health problem.

This means that Qsymia could be used to help people with high blood pressure, type 2 diabetes or high cholesteral to lose weight, if they have a BMI of more than 27, and any adult with a BMI of more than 30.

Last month, the agency gave the go-ahead Arena Pharmaceuticals' Belviq, in which the active ingredient is lorcaserin hydrochloride,  in the first prescription weight loss drug approval by federal regulators in 13 years.

More than a third of American adults meet the definition of obesity, measured using the body mass index (BMI) based on weight and height.

The US Centers for Disease Control and Prevention (CDC) has said that more than 30% of adults in the United States have a BMI of more than 30.

According to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, obesity threatens the overall well-being of patients and is a major public health concern.

She said that Qsymia would provide another option for chronic weight management, if used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise.

People who are overweight and have at least one weight-related comorbid condition are also targeted by the drug.

Phentermine and topiramate have already been approved by the FDA. The former is already in use in overweight or obese adults who are managing to stick to a reduced-calorie diet and exercise programme, but who still need to lose weight.

The latter is used to prevent epileptic seizures and migraine headaches, and apparently boosts the effects of phentermine.

As with Belviq, pregnant women must not take the drug. Qsymia can harm an unborn child, bringing with it an increased risk of birth defects such as a cleft palate.

Women must take a negative pregnancy test before beginning Qsymia therapy, and should take special care not to get pregnant while they are using it, continuing monthly pregnancy tests during treatment, the FDA said in a statement on its website.

Qsymia was shown to be safe and effective in two randomised, placebo-controlled trials in 3,700 obese and overweight adults over the course of a year.

The participants in the trial were also following a reduced calorie diet and an exercise regime.

By the end of the year, nearly 70% of the study participants lost at least 5% of their body weight using Qsymia, compared with just 20% of the control group who took a placebo.
 
The current recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release, but it is also available at a higher dosage of 15 mg phentermine and 92 mg of topiramate extended-release for certain patients.

According to the FDA, patients taking the regular dose of Qsymia who had failed to lose at least 3% of their body weight after 12 weeks of treatment should either stop taking it or progress to a higher dosage, after consultation with their medical practitioner.

People who have certain conditions, including recent heart disease and stroke, or glaucoma or hyperthyroidism should not take Qsymia, which can increase heart rate.

The manufacturer Vivus Inc has pledged to carried out longer-term studies evaluating the effect of Qsymia on cardiovascular outcomes, the FDA said.

Belviq's manufacturer has made similar commitments following question marks over its safety and effectiveness.







The US drug agency has approved a weight-loss drug for the treatment of obesity in people who are already on a calorie-reduced diet and exercise programme.

The Food and Drug Administration approved Qsymia, a combination of two drugs: phentermine and topiramate, for use in patients with chronic weight-control problems who also have at least one weight-related health problem.

This means that Qsymia could be used to help people with high blood pressure, type 2 diabetes or high cholesteral to lose weight, if they have a BMI of more than 27, and any adult with a BMI of more than 30.

More than a third of American adults meet the definition of obesity, measured using the body mass index (BMI) based on weight and height.

The US Centers for Disease Control and Prevention (CDC) has said that more than 30% of adults in the United States have a BMI of more than 30.

According to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, obesity threatens the overall well-being of patients and is a major public health concern.

She said that Qsymia would provide another option for chronic weight management, if used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise.

People who are overweight and have at least one weight-related comorbid condition are also targeted by the drug.

Phentermine and topiramate have already been approved by the FDA. The former is already in use in overweight or obese adults who are managing to stick to a reduced-calorie diet and exercise programme, but who still need to lose weight.

The latter is used to prevent epileptic seizures and migraine headaches, and apparently boosts the effects of phentermine.

Pregnant women must not take the drug, however, as it can harm an unborn child, bringing with it an increased risk of birth defects such as a cleft palate.

Women must take a negative pregnancy test before beginning Qsymia therapy, and should take special care not to get pregnant while they are using it, continuing monthly pregnancy tests during treatment, the FDA said in a statement on its website.

Qsymia was shown to be safe and effective in two randomised, placebo-controlled trials in 3,700 obese and overweight adults over the course of a year.

The participants in the trial were also following a reduced calorie diet and an exercise regime.

By the end of the year, nearly 70% of the study participants lost at least 5% of their body weight using Qsymia, compared with just 20% of the control group who took a placebo.
 
The current recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release, but it is also available at a higher dosage of 15 mg phentermine and 92 mg of topiramate extended-release for certain patients.

According to the FDA, patients taking the regular dose of Qsymia who had failed to lose at least 3% of their body weight after 12 weeks of treatment should either stop taking it or progress to a higher dosage, after consultation with their medical practitioner.

People who have certain conditions, including recent heart disease and stroke, or glaucoma or hyperthyroidism should not take Qsymia, which can increase heart rate.

The manufacturer Vivus Inc has pledged to carried out longer-term studies evaluating the effect of Qsymia on cardiovascular outcomes, the FDA said.

 

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