Phase III trial of DWP 450 meets primary endpoint in glabellar lines study.- Evolus.
Evolus announced the presentation of data from the Phase III comparative clinical trial of its investigational DWP 450 (prabotulinumtoxinA) 900 kilodalton (kDa) neuromodulator . The study met the primary endpoint of non-inferiority at Day 30 with responder rates of 87.2% in the prabotulinumtoxinA group, 82.8% in the onabotulinumtoxinA group, and 4.2% in the placebo group. The adverse event assessed as study-drug related was 15.5%, 14.6% and 4.1% in the prabotulinumtoxinA, onabotulinumtoxinA and placebo groups, respectively. There were no serious adverse events that were assessed as study-drug related.
In the study, prabotulinumtoxinA and onabotulinumtoxinA, both 900 kDa botulinum toxin type A complexes, were studied in subjects with glabellar lines, also known as "frown lines" between the eyebrows. A total of 540 were enrolled: 245 received prabotulinumtoxinA; 246 received onabotulinumtoxinA; and 49 received placebo. The European and Canadian Phase III study, EVB-003, was presented at the American Academy of Dermatology (AAD) meeting.
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