Topaz Pharmaceuticals announced the FDA has accepted for filing the NDA for ivermectin, a topical cream used to treat head lice in children and adults. The NDA included data from two randomized, double-blind, Phase 3 clinical trials that compared 0.5% ivermectin cream with a vehicle control. In total, data from seven clinical studies including more than 900 subjects receiving active ivermectin were included in the NDA. Under the PDUFA (Prescription Drug User Fee Act ), it is the FDA’s goal to review and act on this NDA by February 7, 2012.
Ivermectin is a broad-spectrum antiparasitic agent that acts by binding selectively to certain ion channels present in invertebrate nerve and muscle cells but not present in mammals. The resulting increase in permeability of the cell membrane causes the death of certain parasites.
For more information call (267) 960-3330 or visit www.topazpharma.com