Qsymia®, formerly knowm as Qnexa, (Vivus Inc, California), is the newest weapon in the battle against obesity, and it genuinely fits the criteria for a successful obesity drug as defined by the National Institutes of Health (NIH).[1] It is the only medication on the market capable of reliably achieving a clinically significant weight loss.If the fat could do "lifestyle intervention" they would not "need" the pill.
In the face of a global obesity crisis, Qsymia has a potentially immense market. Nevertheless, the manufacturer faced a tough battle to finally convince the US regulating authorities to approve it. Set against the backdrop of sibutramine and rimonabant, 2 weight-loss drugs that were withdrawn over serious safety concerns that came to light only during postmarketing surveillance, Qsymia probably will be released as a Schedule IV controlled substance.
Qsymia is a formulation of 2 off-patent drugs already on the market: immediate-release phentermine and controlled-release topiramate. Phentermine is an amphetamine-like compound, currently licensed as a short-term weight loss agent due to its central appetite-inhibiting effects. Topiramate is an anticonvulsant, licensed by the US Food and Drug Administration in 2006 and in Europe in 2009, with well-described weight-loss effects whose mode of action remains unclear but may be due to increased taste aversion.
During phase 2-3 development, Qsymia was tested on over 2000 obese and overweight patients.[2-4] Participants treated with a middle dosage level reportedly lost over 10% of total body weight at baseline. Most of this weight loss occurred within the first 6 months of treatment and was followed by subsequent weight stabilization. After the first year, significant and dose-related improvements in blood pressure, glycemic indices, and lipids were shown. However, it will be difficult to position this agent as a primary treatment for any of these other conditions, as its positive effects appear to be driven by the weight loss it produces rather than any additional effect on these metabolic parameters.
Qsymia is recommended alongside lifestyle intervention for obese persons (BMI > 30) and for overweight persons (BMI > 27) with associated comorbidities, such as type 2 diabetes and hypertension. It will be offered in capsule form in 3 strengths: phentermine-IR/topiramate-CR 3.75/23 mg, 7.5/46 mg, and 15/92 mg. All of these doses are 2- to 4-fold lower than those approved for either drug when used as monotherapies.
I bet on failure, overall.
Qsymia, Qsymiass.
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