BioDelivery Sciences International, Inc. (BDSI) announced that it has completed patient enrolment for its phase III RHAPSODY study on clonidine topical gel. The candidate is being developed for the treatment of painful diabetic neuropathy (PDN).
The multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of clonidine topical gel for 12 weeks for the treatment of pain associated with PDN. BioDelivery Sciences expects to complete treatment of 50% of the patients in the third quarter this year, on the basis of which the company plans an interim analysis. Top-line results from the study are expected by the end of the year.
We note that the RHAPSODY study is the first of two pivotal studies on the basis of which BioDelivery will file for a New Drug Application (NDA) for clonidine in the U.S. for the PDN indication. BioDelivery intends to start its second pivotal study in the first quarter of 2015 and file the NDA in 2016.
The company was also in the news earlier in the month when the FDA approved Bunavail (buprenorphine and naloxone buccal film) for maintenance therapy of opioid dependence. Bunavail peak sales in the U.S. are expected to reach $250 million. BioDelivery also has several pipeline related events lined up in the coming quarters.
BioDelivery Sciences has a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering include Regeneron Pharmaceuticals, Inc. (REGN), Biogen Idec Inc. (BIIB) and The Medicines Company (MDCO). All these stocks carry a Zacks Rank #1 (Strong Buy).
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