HORSHAM, Pa., July 28 /PRNewswire/ — Topaz
Pharmaceuticals Inc., a privately held biotechnology company,
announced positive results of studies of topical ivermectin cream,
which it is developing as a potential treatment of
Pediculus humanus capitis (head lice).
In a Phase 2 dose-ranging study presented at the annual meeting
of the Society for Pediatric Dermatology in Portland, OR, this novel topical
formulation produced a statistically significant eradication of
live lice as compared to vehicle. The results from another
study presented at the meeting indicated that there was minimal
plasma absorption of ivermectin when the topical formulation was
applied to children as young as six months.
“Our foremost goal at Topaz is the successful development of
topical ivermectin as a convenient application for the treatment of
head lice infestations,” said Thomas
Beck, MD, Chief Medical Officer of Topaz Pharmaceuticals.
“These results further support our belief that our topical
ivermectin formulation has the potential to become an important
treatment option. We anticipate concluding Phase 3 trials
imminently and then to quickly progress to file a new drug
application with the U.S. Food and Drug Administration.”
Terri Meinking, PhD, President of
Global Health Associates of Miami,
Inc., presented a poster describing a dose determination study to
establish the optimum concentration of ivermectin. The poster
described a randomized, double-blind, dose-response study of 74
evaluable patients who received treatment with 0.15%, 0.25%, or
0.5% ivermectin, or vehicle. All ivermectin concentrations
(n=51) produced a statistically significant erad
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