Skip to main content

Phentermine and Topiramate Extended Release (Qsymia™)

First Global Approval

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 antiepileptic 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.

This is a preview of subscription content, access via your institution.

Table I
Table II
Fig. 1

References

  1. Pi-Sunyer X. The medical risks of obesity. Postgrad Med 2009; 121 (6): 21–33

    PubMed  Article  Google Scholar 

  2. Abdullah A, Wolfe R, Stoelwinder JU, et al. The number of years lived with obesity and the risk of all-cause and cause-specific mortality. Int J Epidemiol 2011; 40 (4): 985–96

    PubMed  Article  Google Scholar 

  3. Hussain SS, Bloom SR. The pharmacological treatment and management of obesity. Postgrad Med 2011; 123 (1): 34–44

    PubMed  Article  Google Scholar 

  4. Franz MJ, Van Wormer JJ, Crain AL, et al. Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up. J Am Diet Assoc 2007; 107 (10): 1755–67

    PubMed  Article  Google Scholar 

  5. Rodgers RJ, Tschop MH, Wilding JPH. Anti-obesity drugs: past, present and future. Dis Model Mech 2012; 5 (5): 621–6

    PubMed  Article  CAS  Google Scholar 

  6. FDA approves weight-management drug Qsymia. FDA News Release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312468.htm (Accessed 10 Sept 2012)

  7. Rothman RB, Baumann MH. Appetite suppressants, cardiac valve disease and combination pharmacotherapy. Am J Ther 2009; 16 (4): 354–64

    PubMed  Article  Google Scholar 

  8. Rosenstock J, Hollander P, Gadde KM, et al. 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. Diabetes Care 2007; 30: 1480–6

    PubMed  Article  CAS  Google Scholar 

  9. Gadde KM, Allison DB. Combination therapy for obesity and metabolic disease. Curr Opin Endocrinol Diabetes Obes 2009 Oct; 16 (5): 353–8

    PubMed  Article  Google Scholar 

  10. VIVUS Inc. Vivus Announces FDA Approval of Once Daily Qsymia™ (Phentermine and Topiramate Extended-release) Capsules CIV. http://www.vivus.com, 17 Jul 2012. Media Release

  11. Qsymia (phentermine and topiramate extended-release) capsules for oral use. US Prescribing Information. 2012

  12. VIVUS. VIVUS Reports Topline Findings From FORTRESS. www.vivus.com, 21 Dec 2011. Media Release

  13. VIVUS Inc. VIVUS Files European Marketing Authorization Application for QNEXA in the Treatment of Obesity. www.vivus.com, 20 Dec 2010. Media Release

  14. VIVUS Inc. VIVUS Provides Update on Timing of European Decision for Qnexa(R). www.vivus.com, 05 Jun 2012. Media Release

  15. VIVUS Inc. VIVUS Provides Update on the Review of the Qsiva Marketing Authorization Application. www.vivus.com, 21 Sep 2012. Media Release

  16. VIVUS Inc.VIVUS Announces Issuance of Key Patent for Qnexa(TM) — A Novel Therapy to Treat Obesity. www.vivus.com, 13 Jun 2006 Media Release

  17. VIVUS Inc.VIVUS Announces the Issuances of Three Additional Qnexa(R) Patents. www.vivus.com, 08 Mar 2010. Media Release

  18. VIVUS Inc. VIVUS Announces Issuance of Key European Patent for Qnexa™. www.vivus.com, 13 Jan 2009. Media Release

  19. Hommel JD, Stroup AE, Al-Barazanuji KA, et al. Combination treatment with topiramate and phentermine (Qnexa) modifies binge eating, craving for highly palatable food and food reward sensitivity. 40th Annual Meeting of the Society for Neuroscience.: abstr. 648.7/H8, 13 Nov 2010. Available from URL: http://www.sfn.org

  20. Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomized, placebo-controlled, phase 3 trial. Lancet 2011; 377 April 16:1341–52

    PubMed  Article  CAS  Google Scholar 

  21. Kolotkin RL. Quality of life is improved with controlled-release phentermine/topiramate in overweight and obese patients. Presentation at American Association of Diabetes Educators (AADE) Las Vagas, NV, 5 Aug, 2011

  22. Van Gaal LF, Garvey WT, Troupin B, et al. Phentermine/topiramate combination therapy significantly improves glucose impairment in overweight/obese patients. 46th Annual Meeting of the European Association for the Study of Diabetes.: abstr. 773, 20 Sep 2010. Available from URL: http://www.easd.org

  23. Garvey WT, Henry RR, Peterson CA, et al. Weight loss with controlled-release phentermine/topiramate (PHEN/TPM CR) reverses metabolic syndrome (MetS) and improves associated traits. 71 st Annual Scientific Sessions of the American Diabetes Association.: abstr. 1875-P, 26 Jun 2011

  24. Garvey WT, Ryan DH, Look M, et al. 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. Am J Clin Nutr 2012; 95: 297–308

    PubMed  Article  CAS  Google Scholar 

  25. Toplak H, Rössner S, Garvey WT, et al. Long-term weight loss with controlled-release phentermine/topiramate reverses metabolic syndrome and improves associated traits. 47th Annual Meeting of the European Association for the Study of Diabetes.: abstr. 905, 12 Sep 2011

  26. Garvey WT, Troupin B, Day WW. Decreased progression to diabetes in subjects with prediabetes after 2 years of treatment with controlled-release phentermine/topiramate. 47th Annual Meeting of the European Association for the Study of Diabetes.: abstr. 907, 12 Sep 2011

  27. Van Gaal LF, Cheskin LJ, Najarian T, et al. Long-term glycaemic effects of weight loss with low-dose, controlled-release phentermine/topiramate (PHEN/TPM CR) in overweight/obese subjects with diabetes. 47th Annual Meeting of the European Association for the Study of Diabetes.: abstr. 906, 12 Sep 2011

  28. Allison DB, Gadde KM, Garvey WT, et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity 2012; 20 (2): 330–42

    PubMed  Article  CAS  Google Scholar 

  29. Ryan DH, Peterson C, Troupin B, et al. Weight loss at 6 months with VI-0521 (PHEN/TPM combination) treatment. Abstr. HT:PO.22 Obes Facts 2010: 139–46

  30. Aronne LJ, Peterson C, Troupin B, et al. Weight loss with VI-0521 (phentermine/controlled release topiramate) stops progression toward type 2 diabetes in obese non-diabetic subjects. 69th Annual Scientific Sessions of the American Diabetes Association.: abstr. 119-OR, 5 Jun 2009

  31. Gadde KM, Yonich GM, Foust MS, et al. A 24-week randomized controlled trial of VI-0521, a combination weight loss therapy, in obese adults. 2006 Annual Meeting of the North American Association for the Study of Obesity; abstr. 55-OR. Obesity (Silver Spring, Md.) 14 (Suppl.): 17–18, No. 9, Sep 2006

  32. Gadde KM, Kolotkin RL, Peterson CA, et al. Changes in weight and quality of life in obese adults treated with topiramate plus phentermine. 2007 Annual Meeting of the North American Association for the Study of Obesity; abstr. 272-P. Obesity (Silver Spring, Md.) 14 (Suppl.): 17–18, No. 9, Sep 2006

  33. Winslow DH, Bowden CH, DiDonato K, et al. A randomized, double-blind, placebo-controlled, parallel-group study of VI-0521 for the treatment of obstructive sleep apnea/hyponea syndrome in obese adults. 24th Annual Meeting of the Associated Professional Sleep Societies; abstr. 0475. 8 Jun 2010. Sleep 2010 33, suppl.: A161

  34. Garvey WT, Troupin B, Tam P, et al. Effect of VI-0521 (phentermine and topiramate) in type 2 diabetes. Diabetes 57 (Suppl. 1): 112 abstr. 390-OR, Jun 2008

  35. Garvey Wt, Day WW, Peterson CA, et al. The weight effects of VI-0521 in type 2 diabetes. Annual Scientific Meeting of the North American Association for the Study of Obesity: abstr. 845-P Obesity 2008; 16 (Suppl. 1): S294

    Google Scholar 

  36. VIVUS Inc. Positive Results From Phase 2 Study of Qnexa in Obstructive Sleep Apnea Presented at Sleep Meeting. www.vivus.com, 08 Jun 2010 Media Release

  37. Garvey WT, Troupin B, Tam P, et al. One-year treatment with VI-0521 in type 2 diabetes demonstrates continued glycemic improvement and weight loss. 69 th Annual Scientific Sessions of the American Diabetes Association: abstr. 361-OR, 5 Jun 2009. Available from URL: http://ww2.aievolution.com

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Glenn Whiteside.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Cameron, F., Whiteside, G. & McKeage, K. Phentermine and Topiramate Extended Release (Qsymia™). Drugs 72, 2033–2042 (2012). https://doi.org/10.2165/11640860-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11640860-000000000-00000

Keywords

  • Topiramate
  • Extended Release
  • Phentermine
  • Oral Cleft
  • Extended Release Formulation