VIVUS Inc. has announced today the availability of Qsymia for the treatment of obesity. (The drug was previously called (Qnexa) Approved by the Food and Drug Administration, studies indicated patients with obesity had an average 10% weight loss when used in conjunction with a lifestyle modification program.
According to the VIVUS press release:
The safety and efficacy of Qsymia were evaluated in two multicenter, phase 3 trials that included more than 3,700 patients: severely obese patients (the EQUIP study) and overweight or obese patients with at least two weight-related comorbidities, such as hypertension, hypertriglyceridemia, type 2 diabetes or central adiposity (the CONQUER study). The average weight loss in EQUIP was 10.9% on Qsymia 15 mg/92 mg and 1.6% for placebo (ITT-LOCF, p<0.0001). The average weight loss in CONQUER was 9.8% on Qsymia 15 mg/92 mg, 7.8% on Qsymia 7.5 mg/46 mg and 1.2% for placebo (ITT-LOCF, p<0.0001).
The most common adverse reactions for patients treated with Qsymia included tingling sensation of hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth.
The Qsymia REMS program is intended to inform prescribers and female patients of reproductive potential about the following: an increased risk of orofacial clefts in infants exposed to Qsymia during the first trimester of pregnancy; the importance of pregnancy prevention for females of reproductive potential receiving Qsymia; and the need to discontinue Qsymia immediately if pregnancy occurs.
For more information about Qsymia, go to www.Qsymia.com.
For full prescribing information go to http://vivus.com/docs/QsymiaPI.pdf.