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Weight loss drug

Qsymia achieves greater weight loss at lower doses

Qsymia achieved 10% weight loss, was well tolerated and improved blood pressure

Qsymia (phentermine and topiramate extended-release) capsules CIV produced significantly greater weight loss, and at lower doses, compared to phentermine or topiramate administered as monotherapies in obese adults, according to a study published online in the journal Obesity.

Qsymia was designed to allow once-daily dosing, with phentermine immediate-release (IR) released in the morning and topiramate extended-release (ER) released in the evening. The delayed release of topiramate ER lowers the maximum observed plasma drug concentration by 29% and delays the time to maximum plasma concentration by seven hours.

In the study, patients completing 28 weeks of treatment on Qsymia 7.5mg/46mg and 15mg/92mg were able to reduce their weight by 11% and 12%, respectively. Greater improvements in waist circumference, glycosylated haemoglobin (HbA1c) and adiponectin were also seen in Qsymia-treated patients compared to those receiving treatment with the individual components.

"The extended-release formulation of Qsymia is key to providing the greatest level of weight-loss efficacy while minimizing tolerability concerns," said Dr Louis Aronne, Professor of Clinical Medicine at Weill Cornell Medical College and Medical Director of Center for Weight Management and Metabolic Clinical Research at New York-Presbyterian/Weill Cornell Medical Center, and a lead investigator in the study. "For decades, phentermine has been a mainstay in the medical treatment of obesity, but when combined with topiramate in an extended-release formulation, we see greater weight loss, less heart rate increase and greater reduction in blood pressure."

A 28-week, randomised, controlled trial compared the combination of phentermine and topiramate extended-release (PHEN/TPM ER) with its components as monotherapies and with placebo in obese adults.

Subjects were randomized to placebo, phentermine 7.5mg, phentermine 15mg, topiramate ER 46mg, topiramate ER 92mg, PHEN/TPM ER 7.5/46mg, or PHEN/TPM ER 15/92mg. All subjects received lifestyle intervention counseling. Primary endpoints were percent weight loss and achievement of ≥5% weight loss.

At week 28, PHEN/TPM ER 7.5/46 (-8.5%) and 15/92 (-9.2%) achieved greater percentage weight loss versus placebo (-1.7%; P < 0.0001) and their respective monotherapies (p<0.05). The percentage of subjects achieving ≥5% weight loss was 15.5% for placebo, 43.3% for phentermine 7.5, 46.2% for phentermine 15, 39.2% for topiramate ER 46, 48.6% for topiramate ER 92, 62.1% for PHEN/TPM ER 7.5/46, and 66.0% for PHEN/TPM ER 15/92.

The authors said that the results suggest that an enhanced ability of the combination formulation to induce weight loss at doses lower than with available monotherapies.

Qsymia is approved in the US and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI 30 or greater or 27 or greater in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes or high cholesterol.

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