The Phase IIb study is designed to evaluate the safety and efficacy of QR-333, a topical formulation designed to offer physicians and patients an effective, easy to administer, safe treatment for diabetic peripheral neuropathy with little to no side effects.
The company believes that a safe and efficacious topical product, if approved by the FDA, could be a ‘first line’ treatment for diabetic peripheral neuropathy and possibly could develop a significant market position in a growing therapeutic category currently dominated by systemic therapies.
The Phase IIb trial will evaluate the safety and efficacy of QR-333, applied three times daily as compared to placebo-treated patients over 12 weeks. Efficacy will be determined by symptom assessment scores, a visual analogy scale, quality of life and sleep questionnaires. Safety will be determined by medical history, physical examination, vital signs, laboratory tests and nerve conduction studies.
The company, after collecting all the patient information from 21 study centers and conferring with its panel of experts on the data, will draft and report study conclusions, as soon they are available.