Galderma Pharma S.A. Announces Positive US Pivotal Interim 6-Month Results for EMERVEL Classic Lidocaine Compared to Juvederm Ultra
10/20/2011 11:03:55 AM
LAUSANNE, Switzerland--(BUSINESS WIRE)--Galderma Pharma S.A., today announced positive interim 6-month results from an ongoing U.S. pivotal clinical study investigating the safety and efficacy of EMERVEL Classic Lidocaine compared to Juvederm Ultra in the treatment of moderate to severe nasolabial folds. Results from this multi-center, evaluator-blinded and randomized split-face comparative clinical study, which evaluated 170 subjects, demonstrated that, at Week 24, EMERVEL Classic Lidocaine was non-inferior to Juvederm Ultra in terms of efficacy. Both products showed a comparable safety profile. EMERVEL Classic Lidocaine presented a favorable pain score profile. The benefit of pre-incorporated lidocaine in EMERVEL was observed rapidly at the time of injection and the pain relief persisted during the 60 minutes of post-injection follow-up.