A Review on the Safety and Efficacy of ATX-101 in the Reduction of Submental Fat

Abstract

Submental fullness, if associated with subcutaneous fat, can detract from an otherwise balanced and harmonious facial appearance - leading to an older and heavier look. According to a 2014 survey by the American Society for Dermatologic Surgery, approximately 7 out of 10 consumers are bothered by submental fullness. Traditional options for submental fullness include cervical rhytidectomy, liposuction and nonsurgical treatment strategies for SMF reduction such as mesotherapy; however, these methods are not without side effects and complications. ATX-101 is a first-in-class, injectable drug that has been developed for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat (SMF). Treatment with ATX-101 represents a nonsurgical, in-office procedure for reduction of SMF with no general anesthesia, and is a less invasive alternative to liposuction with or without neck lift. Across all studies, the efficacy results consistently demonstrate the superiority of ATX-101 relative to placebo in the reduction of SMF. The safety and tolerability of ATX-101 have been well characterized across a comprehensive development program and are acceptable. Therefore, given the overall balance of risks and benefits described, ATX-101 represents a safe, effective, and less invasive alternative to current treatment options for improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.