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news.Two pre-clinical toxicity studies of QR-333, a topical compound developed by Quigley Pharma for the treatment of diabetic neuropathy, have shown that the cream is safe for topical application.
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QR-333 is designed and formulated to significantly decrease the symptoms associated with diabetic peripheral neuropathy.
The results of the first study conducted on hairless guinea pigs concluded that there was no evidence of primary irritancy, photo toxicity, contact hypersensitivity or photoallergy in response to topical administration of the placebo or the QR-333 cream at a dose volume as high as 0.6 ml.
The second study conducted on Gottingen Minipigs revealed that there was essentially no difference in the dermal response to either active or placebo creams. The incidence and degree of the various parameters were similar in the control and drug-treated groups.
The results of the clinical observations that included opthalmologic examinations, electrocardiograms, clinical pathology studies and necropsy did not suggest any event that could be an indication of an adverse systemic effect.
“Based on the strength of this safety data, we are hoping to secure the permission of the FDA to begin a phase IIb study to develop the most efficacious dose range of this topical compound on human patients diagnosed with diabetic peripheral neuropathy,” said Dr Richard Rosenbloom, chief operating officer, Quigley Pharma.