Earlier this month, Novo Nordisk published results from a Phase II trial involving 957 participants demonstrating the weight-loss efficacy of semaglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist, in non-diabetic patients.
These positive results, which showed that 65% of those receiving once-daily semaglutide lost 10% or more of body weight after 52 weeks, raise speculation that semaglutide or other GLP-1 receptor agonists could become a potential treatment for binge eating disorder (BED).
BED was first recognised as a distinct disorder by the American Psychiatric Association in 2013, and it is the most prevalent eating disorder in the US, with approximately 2% of Americans being affected by BED during their lifetimes. Since the inclusion of BED in DSM-5, only one product—Vyvanse (lisdexamfetamine dimesylate), a dexamphetamine prodrug that was originally approved for attention deficit hyperactivity disorder (ADHD)—has been approved by the FDA specifically for the treatment of BED.
The majority of pharmacotherapies for BED, which include antidepressants and anti-obesity drugs, are currently prescribed off-label. Novo Nordisk’s older GLP-1 product Saxenda (liraglutide) is a once-daily injection anti-obesity drug that is used in BED treatment and is one of the few products to have been clinically investigated specifically for treating obesity in BED patients.
Saxenda was included in the latest semaglutide trial for obesity treatment as an active comparator, with 3mg of liraglutide resulting in a mean weight loss of 7.8% of baseline after 52 weeks compared with 13.8% in patients receiving 0.4mg of semaglutide.
Saxenda is currently being investigated further for BED treatment in a trial conducted by the University of Pennsylvania. Key opinion leaders (KOLs) interviewed by GlobalData indicated that results demonstrating a reduction in binge eating episodes, rather than just weight loss, would encourage greater off-label use in the BED population.
If positive results are obtained from this study, it may indicate that GLP-1 products are effective treatments for underlying causes of BED as well as effective weight-loss measures. Novo Nordisk would be well-positioned to begin clinical development of semaglutide for BED, which has a much-improved dosing regimen and weight-loss efficacy compared with Saxenda.
Primary research conducted by GlobalData has indicated a larger BED patient population becoming available over the next five years through an improved diagnosis rate, mainly due to increased awareness of BED amongst physicians. There is a large opportunity in an untapped BED market for newer, improved GLP-1 products with longer exclusivity remaining, which also includes Eli Lilly’s Trulicity (dulaglutide), to be investigated to achieve label extensions in BED.
GlobalData (2018). Binge Eating Disorder: Opportunity Analysis and Forecasts to 2027, to be published
For more insight and data, visit the GlobalData Report Store – Drug Development Technology is part of GlobalData Plc.