Investigational Injectable Found Safe, Effective for Submental Fat

An investigational injectable drug for the reduction of submental fat called ATX-101 from Kythera Biopharmaceuticals was found both safe and effective in new data presented at the AAD Meeting in Miami. In the open-label Phase IIIb study, interim results three months after the last ATX-101 treatment found that 87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). Similarly, 83 percent of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS). In addition, 96 percent of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale (SMSLG), while 95 percent of patients were satisfied with treatment based on the Global Post Treatment Satisfaction Scale. The authors also noted that adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area.