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news.The Quigley Corporation has filed an application with the FDA to begin human testing of QR-333, the company's investigational topical compound for the treatment of diabetic peripheral neuropathy.
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The filing allows Quigley Pharma, a wholly owned subsidiary of Quigley Corporation, to begin human clinical trials following a 30-day review period. If the FDA has no further comments, the company said that studies with human subjects will commence as soon as possible pending the availability of the study drug.
Included within the approximate 3800 page investigational new drug application (IND) are protocols for two studies including a phase IIb human study designed to evaluate the efficacious dose range of the compound and a phase II pharmacokinetic study evaluating safety.
“The filing of this IND is a milestone in the drug development process as well as for Quigley Pharma,” stated Dr Richard Rosenbloom, COO of Quigley Pharma. “As we have already received FDA’s comments on our IND program during Pre-IND meetings and teleconferences, we are prepared to begin these clinical trials as soon as possible.”