BioDelivery Sciences Closes Patient Enrollment In Phase 3 Study - Quick Facts

(RTTNews) - BioDelivery Sciences International, Inc. (BDSI) Thursday said it has finished enrollment of patients for its initial Phase 3 study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy or PDN.

The Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with PDN.

In the trial, referred to as the RHAPSODY Study, 140 adult patients are randomized to receive either Clonidine Topical Gel or a placebo gel, over a period of 12 weeks. This is the first of two studies, based on which the company would file a New Drug Application to the U.S. Food and Drug Administration or FDA. FDA has granted Fast Track designation for the program, which recognizes the need of developing new therapies for this serious condition.

The company is now rolling over patients from the first Phase 3 trial into the 12-month long-term safety study and expects to begin the second study in the first quarter of next year. The overall program is being conducted in patients showing functional skin nociceptors, which is the population of patients that demonstrated a statistically significant difference compared with placebo on the primary efficacy endpoint in a previously conducted Phase 2 study.