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FDA approves weight-management drug Qsymia
The U.S. Food and Drug Administration today approved Qsymia (phentermine and
topiramate extended-release) as an addition to a reduced-calorie diet and
exercise for chronic weight management.
The drug is approved for use in adults with a body mass index (BMI) of 30 or
greater (obese) or adults with a BMI of 27 or greater (overweight) who have
at least one weight-related condition such as high blood pressure (
hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
BMI, which measures body fat based on an individual’s weight and height, is
used to define the obesity and overweight categories. According to the
Centers for Disease Control and Prevention, more than one-third of adults in
the United States are obese.
“Obesity threatens the overall well being of patients and is a major public
health concern,” said Janet Woodcock, M.D., director of the FDA’s Center
for Drug Evaluation and Research. “Qsymia, used responsibly in combination
with a healthy lifestyle that includes a reduced-calorie diet and exercise,
provides another treatment option for chronic weight management in Americans
who are obese or are overweight and have at least one weight-related
comorbid condition.”
Qsymia is a combination of two FDA-approved drugs, phentermine and
topiramate, in an extended-release formulation. Phentermine is indicated for
short-term weight loss in overweight or obese adults who are exercising and
eating a reduced calorie diet. Topiramate is indicated to treat certain
types of seizures in people who have epilepsy and to prevent migraine
headaches.
Qsymia must not be used during pregnancy because it can cause harm to a
fetus. Data show that a fetus exposed to topiramate, a component of Qsymia,
in the first trimester of pregnancy has an increased risk of oral clefts (
cleft lip with or without cleft palate). Females of reproductive potential
must not be pregnant when starting Qsymia therapy or become pregnant while
taking Qsymia. Females of reproductive potential should have a negative
pregnancy test before starting Qsymia and every month while using the drug
and should use effective contraception consistently while taking Qsymia.
The safety and efficacy of Qsymia were evaluated in two randomized, placebo-
controlled trials that included approximately 3,700 obese and overweight
patients with and without significant weight-related conditions treated for
one year. All patients received lifestyle modification that consisted of a
reduced calorie diet and regular physical activity.
The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine
and 46 mg of topiramate extended-release. Qsymia is also available at a
higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for
select patients.
Results from the two trials show that after one year of treatment with the
recommended and highest daily dose of Qsymia, patients had an average weight
loss of 6.7 percent and 8.9 percent, respectively, over treatment with
placebo. Approximately 62 percent and 69 percent of patients lost at least
five percent of their body weight with the recommended dose and highest dose
of Qsymia, respectively, compared with about 20 percent of patients treated
with placebo.
Patients who did not lose at least three percent of their body weight by
week 12 of treatment with Qsymia were unlikely to achieve and sustain weight
loss with continued treatment at this dose. Therefore, response to therapy
with the recommended daily dose of Qsymia should be evaluated by 12 weeks to
determine, based on the amount of weight loss, whether to discontinue
Qsymia or increase to the higher dose. If after 12 weeks on the higher dose
of Qsymia, a patient does not lose at least five percent of body weight,
then Qsymia should be discontinued, as these patients are unlikely to
achieve clinically meaningful weight loss with continued treatment.
Qsymia must not be used in patients with glaucoma or hyperthyroidism. Qsymia
can increase heart rate; this drug’s effect on heart rate in patients at
high risk for heart attack or stroke is not known. Therefore, the use of
Qsymia in patients with recent (within the last six months) or unstable
heart disease or stroke is not recommended. Regular monitoring of heart rate
is recommended for all patients taking Qsymia, especially when starting
Qsymia or increasing the dose.
The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS
), which consists of a Medication Guide advising patients about important
safety information and elements to assure safe use that include prescriber
training and pharmacy certification. The purpose of the REMS is to educate
prescribers and their patients about the increased risk of birth defects
associated with first trimester exposure to Qsymia, the need for pregnancy
prevention, and the need to discontinue therapy if pregnancy occurs. Qsymia
will only be dispensed through specially certified pharmacies.
Vivus Inc. will be required to conduct 10 postmarketing requirements,
including a long-term cardiovascular outcomes trial to assess the effect of
Qsymia on the risk for major adverse cardiac events such as heart attack and
stroke.
The most common side effects of Qsymia are tingling of hands and feet (
paresthesia), dizziness, altered taste sensation, insomnia, constipation,
and dry mouth.
Qsymia is marketed by Vivus Inc. in Mountain View, Calif.
FDA approves weight-management drug Qsymia
The U.S. Food and Drug Administration today approved Qsymia (phentermine and
topiramate extended-release) as an addition to a reduced-calorie diet and
exercise for chronic weight management.
The drug is approved for use in adults with a body mass index (BMI) of 30 or
greater (obese) or adults with a BMI of 27 or greater (overweight) who have
at least one weight-related condition such as high blood pressure (
hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
BMI, which measures body fat based on an individual’s weight and height, is
used to define the obesity and overweight categories. According to the
Centers for Disease Control and Prevention, more than one-third of adults in
the United States are obese.
“Obesity threatens the overall well being of patients and is a major public
health concern,” said Janet Woodcock, M.D., director of the FDA’s Center
for Drug Evaluation and Research. “Qsymia, used responsibly in combination
with a healthy lifestyle that includes a reduced-calorie diet and exercise,
provides another treatment option for chronic weight management in Americans
who are obese or are overweight and have at least one weight-related
comorbid condition.”
Qsymia is a combination of two FDA-approved drugs, phentermine and
topiramate, in an extended-release formulation. Phentermine is indicated for
short-term weight loss in overweight or obese adults who are exercising and
eating a reduced calorie diet. Topiramate is indicated to treat certain
types of seizures in people who have epilepsy and to prevent migraine
headaches.
Qsymia must not be used during pregnancy because it can cause harm to a
fetus. Data show that a fetus exposed to topiramate, a component of Qsymia,
in the first trimester of pregnancy has an increased risk of oral clefts (
cleft lip with or without cleft palate). Females of reproductive potential
must not be pregnant when starting Qsymia therapy or become pregnant while
taking Qsymia. Females of reproductive potential should have a negative
pregnancy test before starting Qsymia and every month while using the drug
and should use effective contraception consistently while taking Qsymia.
The safety and efficacy of Qsymia were evaluated in two randomized, placebo-
controlled trials that included approximately 3,700 obese and overweight
patients with and without significant weight-related conditions treated for
one year. All patients received lifestyle modification that consisted of a
reduced calorie diet and regular physical activity.
The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine
and 46 mg of topiramate extended-release. Qsymia is also available at a
higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for
select patients.
Results from the two trials show that after one year of treatment with the
recommended and highest daily dose of Qsymia, patients had an average weight
loss of 6.7 percent and 8.9 percent, respectively, over treatment with
placebo. Approximately 62 percent and 69 percent of patients lost at least
five percent of their body weight with the recommended dose and highest dose
of Qsymia, respectively, compared with about 20 percent of patients treated
with placebo.
Patients who did not lose at least three percent of their body weight by
week 12 of treatment with Qsymia were unlikely to achieve and sustain weight
loss with continued treatment at this dose. Therefore, response to therapy
with the recommended daily dose of Qsymia should be evaluated by 12 weeks to
determine, based on the amount of weight loss, whether to discontinue
Qsymia or increase to the higher dose. If after 12 weeks on the higher dose
of Qsymia, a patient does not lose at least five percent of body weight,
then Qsymia should be discontinued, as these patients are unlikely to
achieve clinically meaningful weight loss with continued treatment.
Qsymia must not be used in patients with glaucoma or hyperthyroidism. Qsymia
can increase heart rate; this drug’s effect on heart rate in patients at
high risk for heart attack or stroke is not known. Therefore, the use of
Qsymia in patients with recent (within the last six months) or unstable
heart disease or stroke is not recommended. Regular monitoring of heart rate
is recommended for all patients taking Qsymia, especially when starting
Qsymia or increasing the dose.
The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS
), which consists of a Medication Guide advising patients about important
safety information and elements to assure safe use that include prescriber
training and pharmacy certification. The purpose of the REMS is to educate
prescribers and their patients about the increased risk of birth defects
associated with first trimester exposure to Qsymia, the need for pregnancy
prevention, and the need to discontinue therapy if pregnancy occurs. Qsymia
will only be dispensed through specially certified pharmacies.
Vivus Inc. will be required to conduct 10 postmarketing requirements,
including a long-term cardiovascular outcomes trial to assess the effect of
Qsymia on the risk for major adverse cardiac events such as heart attack and
stroke.
The most common side effects of Qsymia are tingling of hands and feet (
paresthesia), dizziness, altered taste sensation, insomnia, constipation,
and dry mouth.
Qsymia is marketed by Vivus Inc. in Mountain View, Calif.
