Qsymia Weight Loss Therapy for Men

Addressing an American Obesity Epidemic

Approximately 78 million Americans are obese (more than one third of the adult population), presenting a major health concern for our country. Worldwide there are over 500 million people suffering from obesity. Obesity is currently the second leading cause of preventable death in the U.S., contributing to many life-threatening illnesses including cardiovascular disease, hypertension, diabetes, and stroke.

The negative effects of obesity extend beyond health. Economically, obesity accounts for about 9.1% of health care costs in the U.S.—roughly $150 billion a year. It’s estimated that by 2030 the annual costs of obesity will reach $965 billion, if trends continue. If that happens, then $1 out of every $6 of health care spending will be spent on obesity, or 18% total.

Introducing Qsymia

Qsymia® is an investigational weight-loss therapy combining low doses of phentermine and topiramate, two agents that have been approved by the Food and Drug Administration. Qsymia Extended Release Capsules are meant to be taken once-per-day, and are formulated to release slowly in a controlled manner.

Qsymia’s Status

Qsymia NDA was resubmitted on October 17, 2011 for approval by the FDA. The FDA announced on November 3, 2011, that they would accept Qsymia NDA for review and filing. The FDA approved Qsymia in July, 2012, as a weight-loss medication.

Clinical Studies

Clinical studies have shown that patients who take Qsymia demonstrate weight loss. Patients who combined Qsymia with an improved diet and exercise program also experienced improved glycemic control and risk factors for cardiovascular disease. Patients reported side effects including dry mouth, tingling, and constipation.

EQUIP Study

Published in the peer-reviewed journal of The Obesity Society, Obesity, The EQUIP study tested the safety and efficacy of Qsymia over the course of 56 weeks and involving 1,267 severely obese patients in the U.S. Highlights from the study include:

  • An average weight loss of 14.4% for top-dose Qsymia, and an average weight loss of 6.7% for low dose Qsymia (the placebo group experienced an average 2.1% weight loss).
  • Of all the patients who completed the entire study, 85.5% lost at least 5% of their baseline weight, 67.7% lost at least 10%, and 48.1% lost at least 15%.
  • The mean weight loss percentage was 10.9% for the top-dose group, and 5.1% for the low-dose group, with the placebo group losing 1.6% of their baseline weight.

Tingling was the most commonly reported side effect, as well as dry mouth, constipation, altered taste, and insomnia.

CONQUER Study

The CONQUER Study was published in the peer-reviewed journal The Lancet, and evaluated a group of 2,487 patients in the U.S. taking Qsymia over a 56-week period. In addition to weight loss, the CONQUER study also took into account improvements in cardiovascular, inflammatory, and metabolic risk factors. Highlights include:

  • LS Mean weight loss percentage of 7.8% for mid dose and 9.8% for top dose (compared to 1.2% in the placebo group).
  • 70% of participants in the top dose group lost at least 5% of their baseline body weight, and 48% lost at least 10%.
  • Patients who received Qsymia experienced improvements in co-morbidities and needed fewer concomitant medications, compared with the placebo group.

The most commonly reported side effect was dry mouth, and other side effects included tingling, constipation, insomnia, dizziness, and altered taste. There was a low drop-out rate (9% for the placebo group, 12% for the middle group, and 19% for the top group), mostly due to adverse events early in treatment.

SEQUEL Study

Extending the CONQUER Study for a year, the SEQUEL study evaluated the effects and safety of Qsymia. Following 676 patients, the study period lasted 108 weeks. The SEQUEL study was published in the peer=reviewed journal The American Journal of Clinical Nutrition. Some highlights of the study include:

  • Average weight loss for the mid-level group was 9.3%, and 10.5% for the top dose group (the placebo group only experienced 1.8% weight loss over 108 weeks).
  • Cardiovascular and metabolic risk factors improved for Qsymia patients, as well as a decreased need for medications to treat these risk factors.
  • The placebo group was three times likelier to get type 2 diabetes compared with the top dose group (and two times likelier than the middle-dose group).

Side effects included respiratory infection, constipation, tingling, sinus infection, dry mouth, and runny nose.