What are the results of Kybella clinical trials?
In the pooled, pivotal Phase I studies, 68.2 percent of patients responded to Kybella based on a composite of validated physician and patient measurements. Many patients experienced visible results in two to four treatments. Kybella treatment resulted in high patient satisfaction.
In clinical studies, 28%, 43% and 55% of Kybella-treated patients had a ≥1-grade composite improvement after 2, 3 and 4 treatments, respectively.
Patients also reported improvement in the emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.
Is Kybella safe?
Kybella has been the focus of a global clinical development program involving over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with Kybella.
Production of Kybella is a highly controlled, quality-assured and validated, current Good Manufacturing Practices-compliant process to ensure patient safety. Kybella contains no human or animal-derived substances.
What are the side effects with Kybella?
The safety profile of Kybella is well characterized. Side effects may include swelling, bruising, pain, numbness, redness or formation of small areas of firmness. Adverse events with Kybella infrequently resulted in discontinuation from study (1.6% of participants). Care must be taken when injecting Kybella to avoid the risk of marginal mandibular nerve injury and dysphagia.