VIVUS (VVUS) Announces New Clinical Data Demonstrate Qsymia is Effective at Reducing Binge Eating in Patients with Binge-Eating Disorder or Bulimia Nervosa

VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company, today announced the results of a clinical study (NCT02553824) demonstrating that patients with binge-eating disorder (BED) or bulimia nervosa (BN) receiving Qsymia (phentermine and topiramate extended-release (ER)) capsules CIV had a significant reduction in binge day frequency compared with placebo over four weeks. Additionally, Qsymia was well tolerated in these patient populations. The study results appear online in the International Journal of Eating Disorders.

"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 Santosh T. Varghese, MD, Chief Medical Officer at VIVUS. "The promising results announced today, along with previously reported data from another study evaluating Qsymia in BED, suggest that Qsymia could address an unmet treatment need in BED and BN and support further investigation of Qsymia as a treatment option for these serious medical conditions."

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 John Amos, Chief Executive Officer at VIVUS. “A growing body of data demonstrates that Qsymia has an excellent safety profile in diverse patient populations and that it may offer clinical benefit across a wide spectrum of weight- and eating-related health conditions.”

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