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.
BioDelivery Sciences remains takeout candidate for Endo, says Summer Street Summer Street believes a potential takeover of BioDelivery Sciences (BDSI) by partner Endo (ENDP) is no less likely after Endo made a bid to acquire Auxilium (AUXL). The firm believes an Endo buyout of BioDelivery is likely a 2015 event when BioDelivery's Bunavail for opioid dependence is on the market and BEMA Buprenorphine is facing FDA approval. Summer Street says it is a buyer of BioDelivery Sciences on weakness this morning and keeps a Buy rating on the name with a $28 price target.