Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials.

ABSTRACT:

Background

ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin.

Objectives

To evaluate the efficacy and safety of ATX-101 by treatment session.

Methods

This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse

SUBMITTER: Dayan SH 

PROVIDER: S-EPMC6094350 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature