Lorcaserin: drug profile and illustrative model of the regulatory challenges of weight-loss drug development

Abstract

Lorcaserin is a selective 5-hydroxytryptamine receptor 2c agonist developed as a weight-loss drug. Phase II and III clinical trials support lorcaserin as not only reducing adiposity (i.e., fat mass), but also as improving the metabolic diseases commonly associated with adiposopathy (i.e., fat dysfunction). At the time of this writing, regulatory processes continue towards evaluating lorcaserin as a potentially marketed weight-loss and weight-maintenance agent. Some of the challenges facing lorcaserin are similar to the difficulties encountered by all investigational weight-loss therapeutic agents, which include evolving paths towards approval. While important for clinicians to understand approval hurdles for all therapeutics, it is especially critical for researchers and developers to grasp the unique regulatory complexities of anti-obesity agents. This article profiles lorcaserin as an illustrative example of general drug development regulatory processes, and specifically details the unique challenge of weight-loss drug development.

Keywords::

• adiposopathy
• dyslipidemia
• FDA
• lorcaserin
• obesity
• regulatory
• ‘sick fat’

Financial & competing interests disclosure

Harold Bays MD has received research grants from Arena, Vivus, Orexigen, as well as numerous other pharmaceutical companies, and has served on advisory panels for Arena and Vivus, as well as numerous other pharmaceutical companies. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Notes

CT: Computed tomography; DEXA: Dual-energy x-ray absorptiometry composition analysis.

Data taken from [10,112].