"Qsymia is the first
The safety and efficacy of Qsymia were evaluated in two multicenter, phase 3 trials that included 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.
Qsymia was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of informing prescribers and female patients of reproductive potential about 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. The Qsymia REMS program includes a Medication Guide, Healthcare Provider training, distribution through certified pharmacies, implementation system and a time table for assessments.
As part of the approval of Qsymia,
Note to Investors
Qsymia Phase 3 Clinical Program
The safety and efficacy of Qsymia were evaluated in two randomized, double-blind, placebo-controlled, phase 3 studies that randomized more than 3,700 patients who were obese (EQUIP) or obese and overweight with two or more weight-related co-morbidities (CONQUER). There were two co-primary efficacy outcomes measured after one year of treatment: 1) the percent weight loss from baseline; and 2) treatment response defined as achieving at least 5% weight loss from baseline.
In the EQUIP study, obese patients (BMI greater than or equal to 35 kg/m2) were randomized to receive one year of treatment with placebo (N=514), Qsymia 3.75 mg/23 mg (N=241), or Qsymia 15 mg/92 mg (N=512).
In the CONQUER study, overweight and obese patients were randomized to receive one year of treatment with placebo (N=994), Qsymia 7.5 mg/46 mg (N=498), or Qsymia 15 mg/92 mg (N=995). Eligible patients had to have a BMI greater than or equal to 27 kg/m2 and less than or equal to 45 kg/m2 (no lower limit on BMI for patients with type 2 diabetes) and two or more obesity-related comorbid conditions.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV must not be used by women who are pregnant; by patients with eye problems (glaucoma); by patients who have been told they have an overactive thyroid; by patients taking a type of anti-depressant called MAOI; or by patients who are allergic to phentermine, topiramate, or any of the ingredients in Qsymia.
Qsymia may harm your unborn baby. If you take Qsymia while you are pregnant, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. You should have a negative pregnancy test before taking Qsymia and every month while taking Qsymia. Use effective birth control (contraception) consistently while taking Qsymia. Talk to your healthcare provider about how to prevent pregnancy. If you become pregnant while taking Qsymia, you should stop taking Qsymia immediately and contact your healthcare provider right away.
Qsymia can increase your heart rate at rest. Tell your healthcare provider if you experience, while at rest, a racing or pounding feeling in your chest lasting several minutes when taking Qsymia.
Topiramate, a component of Qsymia, increases the risk of suicidal thoughts or behavior in patients. Pay attention to any changes and call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression, or other unusual changes in behavior or mood.
Eye problems, such as glaucoma (an increased pressure in the eye due to fluid blockage), may develop while you are taking Qsymia. You should call your healthcare provider if you experience any sudden decrease in vision, with or without eye pain and redness, and stop taking Qsymia immediately. These problems can lead to permanent vision loss if not treated.
Qsymia may affect how you think and is associated with difficulty with attention and concentration, memory and word-finding. Therefore, use caution when operating hazardous machinery, including automobiles.
Weight loss may increase the risk of low blood sugar in patients with type 2 diabetes mellitus treated with insulin. Your healthcare provider may adjust your antidiabetic medicines while you are taking Qsymia.
The most common side effects seen in Qsymia clinical studies were tingling in the hands and feet, dizziness, change in taste, trouble sleeping, constipation, and dry mouth.
To report negative side effects, contact
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," "intend," "likely," "may," "plan," "potential," "predict," "opportunity" and "should," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our lack of commercial experience with Qsymia in the U.S.; the timing of initiation and completion of the clinical studies required as part of the approval of Qsymia by the
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