BioDelivery Sciences completes enrollment for Phase 3 trial of Clonidine BioDelivery Sciences has completed enrollment of all patients required for its initial Phase 3 study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy. The trial is a multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with PDN. This is the first of two pivotal trials that would be required for submission of a New Drug Application to the FDA. FDA has granted Fast Track designation for the program.
Summer Street still feels Endo could acquire BioDelivery Sciences Summer Street reiterated its belief that Endo (ENDP) could acquire BioDelivery Sciences (BDSI), its partner on multiple products. The firm says scripts for BioDelivery's Bunavail continue to trend in the right direction. It reiterates a Buy rating on the stock with a $25 price target.