New Clinical Data Demonstrate VIVUS’ Qsymia® is Effective at Reducing Binge Eating in Patients with Binge-Eating Disorder or Bulimia Nervosa
-Data published in
"Dropout rates for the two pharmacologic therapies approved for BED and BN range from 20 to 30 percent and many patients using these medications remain symptomatic, underscoring the need for alternative therapeutic approaches," said
The randomized, double blind, placebo-controlled, crossover study enrolled 22 patients (BED=18 and BN=4) who were randomized to Qsymia (n=12, 3.75/23 mg phentermine [PHEN]/topiramate [TPM]-ER – 15 mg PHEN/92 mg TPM-ER) or placebo (n=10) for 12 weeks. The mean baseline body mass index for the 22 was 31.1 kg/m2. Following a two-week washout, patients crossed over to the other arm for 12 weeks. The primary outcome was the number of objective binge-eating (OBE) days over four weeks; secondary outcomes included binge abstinence. Demographics, vital signs, eating disorder behaviors, mood and side effect data were also collected.
Key findings from the study include:
- Mean OBE days over four weeks was 16.2 at baseline and decreased to 4.2 days and 13.2 days following Qsymia treatment and placebo, respectively (p < .0001).
- Abstinence rates were 63.6% with Qsymia and 9.1% with placebo (p < .0001).
- Qsymia was associated with a mean decrease in weight of 5.8 kg, compared with a mean gain of 0.4 kg on placebo.
- There was a significant improvement in secondary measures assessing eating disordered related pathologies and comorbid mood symptoms and marked improvements in depressive symptoms were also observed in patients receiving Qsymia compared to placebo.
- No serious adverse events were reported. Patient-reported adverse events while on Qsymia were dry mouth (52.4% of patients), insomnia (28.6%), paresthesia (28.6%), dysgeusia (23.8%), anxiety (14.3%), nausea, cold intolerance, decreased appetite, dizziness, fatigue, hair loss and difficulty finding words (9.5% each).
- Dropout rates were the same between the Qsymia and placebo groups (9%).
- Blood pressure and heart rate changes with Qsymia were minimal and similar to placebo.
- Responses were not significantly different for BED versus BN.
- Binge eating returned and abstinence rates decreased during the eight-week post-treatment follow-up period, suggesting that additional approaches to improved maintenance are needed.
“These data further validate the clinical utility of Qsymia in helping patients with a variety of weight-related health conditions to achieve healthier eating behaviors,” said
Qsymia is approved in the United States and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about VIVUS, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to our ability to execute on our business strategy to enhance long-term stockholder value; risks and uncertainties related to our ability to address our outstanding balance of the convertible notes due in
|VIVUS, Inc.||Investor Relations: Lazar FINN Partners|
|Mark Oki||David Carey|
|Chief Financial Officer||Senior Partner|
Source: VIVUS, Inc.