Qsymia

OBJECTIVE: To estimate the incremental cost-effectiveness of clinically proven nonsurgical commercial weight loss strategies for those with BMIs between 25 and 40. METHODS: We performed a systematic literature review to identify randomized controlled trials of commercially available weight loss studies of at least 1 year in duration. Using the results of these trials and publicly available cost data, we quantified the incremental cost per kilogram of weight loss and per quality adjusted life year (QALY) gained...

As obesity rates continue to rise in the United States, both physicians and patients have demanded more safe and effective drug treatment options. However, following the fen-phen/Redux and sibutramine failures, the FDA has been hesitant to approve any anti-obesity drugs, despite the magnitude of the epidemic. Some have argued that these public embarrassments have led the FDA to overestimate the risks and underestimate the benefits when deciding whether to approve new anti-obesity drugs. On June 27, 2012, the FDA approved Belviq for chronic weight management, making it the first anti-obesity drug approved by the FDA in thirteen years...

The treatment of obesity is often met with a myriad of challenges in the primary care setting. Nevertheless, a modest 5% weight loss is considered clinically significant and may be associated with health benefits. Phentermine/topiramate (Qsymia), available in the United States since September 2012, achieves clinically meaningful weight loss along with improvements in weight-related comorbidities. This combination drug therapy could be an additional tool for primary care providers in their quest for effective management of obesity...

FDA approval of Belviq and Qsymia seems to suggest that novel pharmacological targets to modulate human abnormal eating behaviours are still to be identified. However, a renewed translational approach opens new avenues on eating disorders and female vulnerability, highlighting the role of our reward pathway in obesity and binge eating and leading to potential novel targets. Nevertheless, the 'food addiction' hypothesis is still causing much scientific debate. In this context the interest in the modulation of ghrelin pathway is still very high although, so far, only ghrelin agonism has confirmed its therapeutic potential in cachectic patients...

BACKGROUND AND OBJECTIVE: Very few drugs are approved for obesity treatment by regulatory agencies. Very recently phentermine/topiramate controlled-release [PHEN/TPM CR; (Qsymia®)] obtained Food and Drug Administration (FDA) approval as an addition to a reduced-calorie diet and exercise for chronic weight management. Our aim was to review the available clinical evidence on weight loss, metabolic effects and adverse events associated with use of this product. METHODS: Randomized controlled trials with phentermine/topiramate controlled-release were selected through a Medline search using the terms: phentermine and topiramate, phentermine and controlled release topiramate, new anti-obesity drugs and phentermine/topiramate, recent combinations of anti-obesity drugs and Qnexa®...

Obesity is a risk factor for a wide range of conditions, including cardiovascular disease. Although lifestyle modifications remain the cornerstone for the management of obesity, pharmacologic agents may be a helpful addition to patients who have comorbidities and do not respond adequately to diet and exercise. Lorcaserin and phentermine/topiramate ER are 2 long-awaited agents, approved in 2012 for obesity management, 13 years since orlistat received US Food and Drug Administration approval in 1999. Lorcaserin is a serotonin agonist, whereas phentermine/topiramate is a combination of a sympathomimetic agent and an antiepileptic drug; both these agents have been shown to reduce weight significantly and improve cardiovascular and metabolic parameters, such as blood pressure, lipids, and HbA1C...

Phentermine/topiramate extended-release capsules (Qsymia) for weight loss.

Obesity is a growing pandemic, and related health and economic costs are staggering. Pharmacotherapy, partnered with lifestyle modifications, forms the core of current strategies to reduce the burden of this disease and its sequelae. However, therapies targeting weight loss have a significant history of safety risks, including cardiovascular and psychiatric events. Here, evolving strategies for developing antiobesity therapies, including targets, mechanisms, and developmental status, are highlighted. Progress in this field is underscored by Belviq (lorcaserin) and Qsymia (phentermine/topiramate), the first agents in more than 10 years to achieve regulatory approval for chronic weight management in obese patients...

Obesity-related diseases including diabetes, dyslipidemia, and hypertension worsen quality of life of patients and waste medical expenses. To reduce the excess body weight, anti-obesity drugs that reduce appetite or lipid absorption from the intestine have been developed. Only Mazindol can be used in Japan at present, whereas Orlistat was launched and very recently Lorcaserin and Qsymia have been accepted in the US and/or European countries. In addition, a variety of drugs having various mechanisms have been investigated in clinical and basic stages...

Qsymia™ (Vivus Inc, Mountain View, CA, USA), a combination of phentermine and delayed-release topiramate, has been available in the US since September 2012 for the treatment of obesity. Phentermine is an anorexigenic agent, which is approved for the short-term treatment of obesity, while topiramate is approved for nonweight loss indications - seizure disorders and migraine prophylaxis. The amount of weight loss achieved with combination therapy is of a greater magnitude than what could be achieved with either agent alone...

Obesity is now a major public health concern worldwide with increasing prevalence and a growing list of comorbidities and complications. The morbidity, mortality and reduced productivity associated with obesity and its complications result in a major burden to health care costs. Obesity is a complex chronic medical syndrome often with multiple different etiologic factors in individual patients. The long term successful management of obesity remains particularly challenging and invariably requires a multifaceted approach including lifestyle and behavioral modification, increased physical activity, and adjunctive pharmacotherapy...

After a long period of failure in development, two new medications (phentermine/topiramate ER - Qsymia™ and lorcaserin - Belviq®) have been approved by the US Food and Drug Administration for long-term weight management in persons with obesity (BMI ≥ 30 kg/m(2)) or in overweight persons (BMI ≥ 27 kg/m(2)) with comorbidities. Another medication, bupropion/naltrexone, is undertaking a cardiovascular outcomes trial and an analysis in 2014 will determine its approval and release. The most widely prescribed drug for obesity, phentermine, used since 1959 for short-term weight management, has been released in a new formulation...

Compared to the general population, individuals with psychiatric illness, especially serious and chronic mood and psychotic disorders, are more likely to be overweight or obese, have higher rates of weight-related medical conditions, and have greater non-suicide mortality rates. Lorcaserin (Belviq(®)), phentermine/topiramate combination (Qsymia(®)), and bupropion/naltrexone combination have been demonstrated to be effective for the treatment of obesity, as an adjunct to a reduced-calorie diet and physical activity, although their absolute safety has yet to be established with more widespread use or longer use...

Obesity is a major public health concern associated with increased morbidity and mortality. Its prevalence is rising worldwide mainly due to modern lifestyle habits. Several mechanisms like inflammation, endothelial dysfunction, increased sympathetic tone, high leptin and insulin concentrations as well as enhanced thrombogenesis are implicated to the emergence and progress of cardiovascular disease. Although, changes in the lifestyle remain the cornerstone of antiobesity treatment, alone do not always provide the desired weight loss...

Obesity is a world-wide epidemic associated with significant morbidity and mortality which costs billions of dollars per year. The associated related conditions are many and include heart disease, stroke, type II diabetes mellitus, sleep apnea and certain types of cancer. Given that it is a multifactorial problem, the treatments must also address the numerous causes associated with the development of obesity. The neurohormonal regulation of feeding and energy is a complex system often necessitating modification through more than 1 pathway to achieve weight loss...

OBJECTIVE: To review the pharmacology, efficacy, and safety of phentermine/topiramate (PHEN/TPM) in the management of obese patients. DATA SOURCES: MEDLINE (1966-July 2012) was searched using the terms weight loss, obesity, phentermine and topiramate, phentermine, topiramate, Qnexa, Qsymia, and VI-0521. Additionally, the new drug application and prescribing information for PHEN/TPM were retrieved. STUDY SELECTION/DATA EXTRACTION: All studies considering the pharmacology, efficacy, and safety of PHEN/TPM were reviewed with a focus on efficacy and safety data from Phase 3 trials...

Obesity has reached epidemic proportions and is a significant public health concern. Obesity is associated with increased diabetes, cardiovascular and kidney disease, and associated morbidity and mortality. Despite the increasing public health problem of obesity, there is a dearth of effective treatment options. Following the FDA mandated withdrawal of sibutramine, the treatment options for obesity were limited to orlistat as the only pharmacological treatment option for long-term management of obesity. Recently two new medications (Belviq and Qsymia) were approved by FDA for long-term management of obesity...

Mirabegron (Myrbetriq) for overactive bladder; phentermine/topiramate ER (Qsymia) for weight management; and ocriplasmin injection (Jetrea) for vitreomacular adhesion.

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Vivus' proprietary oral capsule containing phentermine and extended-release (ER) topiramate has been approved in the US for the treatment of obesity. Phentermine is an appetite suppressant, while topiramate is an anti-epileptic medication. The once-daily formulation, known as Qsymia™, is designed to produce weight loss by decreasing appetite and increasing satiety. The product is also in clinical development for sleep apnoea syndrome and type 2 diabetes mellitus. This article summarizes the milestones in the development of phentermine/topiramate ER leading to this first approval for obesity...