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Literature DB >> 23039320

Phentermine and topiramate extended release (Qsymia™): first global approval.

Fiona Cameron¹, Glenn Whiteside, Kate McKeage.

Abstract

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.

Entities: Chemical Disease

Mesh：

Substances：

Year: 2012 PMID： 23039320 DOI： 10.2165/11640860-000000000-00000

Source DB: PubMed Journal: Drugs ISSN： 0012-6667 Impact factor: 9.546

11 in total

Review 1. Appetite suppressants, cardiac valve disease and combination pharmacotherapy.

Authors: Richard B Rothman; Michael H Baumann
Journal: Am J Ther Date: 2009 Jul-Aug Impact factor: 2.688

2. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.

Authors: Kishore M Gadde; David B Allison; Donna H Ryan; Craig A Peterson; Barbara Troupin; Michael L Schwiers; Wesley W Day
Journal: Lancet Date: 2011-04-08 Impact factor: 79.321

3. The number of years lived with obesity and the risk of all-cause and cause-specific mortality.

Authors: Asnawi Abdullah; Rory Wolfe; Johannes U Stoelwinder; Maximilian de Courten; Christopher Stevenson; Helen L Walls; Anna Peeters
Journal: Int J Epidemiol Date: 2011-02-27 Impact factor: 7.196

Review 4. Combination therapy for obesity and metabolic disease.

Authors: Kishore M Gadde; David B Allison
Journal: Curr Opin Endocrinol Diabetes Obes Date: 2009-10 Impact factor: 3.243

5. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients.

Authors: Julio Rosenstock; Priscilla Hollander; Kishore M Gadde; Xiang Sun; Richard Strauss; Albert Leung
Journal: Diabetes Care Date: 2007-03-15 Impact factor: 19.112

Review 6. Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up.

Authors: Marion J Franz; Jeffrey J VanWormer; A Lauren Crain; Jackie L Boucher; Trina Histon; William Caplan; Jill D Bowman; Nicolas P Pronk
Journal: J Am Diet Assoc Date: 2007-10

Review 7. The pharmacological treatment and management of obesity.

Authors: Syed Sufyan Hussain; Stephen Robert Bloom
Journal: Postgrad Med Date: 2011-01 Impact factor: 3.840

8. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study.

Authors: W Timothy Garvey; Donna H Ryan; Michelle Look; Kishore M Gadde; David B Allison; Craig A Peterson; Michael Schwiers; Wesley W Day; Charles H Bowden
Journal: Am J Clin Nutr Date: 2011-12-07 Impact factor: 7.045

Phentermine and topiramate extended release (Qsymia™): first global approval.

Review 1. Appetite suppressants, cardiac valve disease and combination pharmacotherapy.

2. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.

3. The number of years lived with obesity and the risk of all-cause and cause-specific mortality.

Review 4. Combination therapy for obesity and metabolic disease.

5. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients.

Review 6. Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up.

Review 7. The pharmacological treatment and management of obesity.

8. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study.

9. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).

Review 10. Anti-obesity drugs: past, present and future.

1. Successful Treatment of Binge Eating Disorder With Combination Phentermine/Topiramate Extended Release.

2. Novel oral anti-obesity agents: new perspectives with lorcaserin?

3. Treating epilepsy in the setting of medical comorbidities.

Review 4. New pharmacological treatments for the management of obesity.

5. Preparation and evaluation of bilayer-core osmotic pump tablets contained topiramate.

6. Self-regulation, motivation, and psychosocial factors in weight management.

Review 7. Phentermine and topiramate for the management of obesity: a review.