BioDelivery Sciences International, Inc. (BDSI) announced that it has enrolled the first patient in the phase III RHAPSODY study (n=140) that will evaluate clonidine topical gel for the treatment of pain associated with diabetic neuropathy. The multicenter, randomized, double blind, placebo controlled study will evaluate the efficacy and safety of clonidine topical gel for 12 weeks in patients with functional skin nociceptors compared to a placebo gel.
Interim data from the study is expected in the fourth quarter of 2014 after BioDelivery Sciences completes treatment of 50% of the patients. On the basis of this data, the company will start a second phase III study on clonidine by the end of 2014.
Final results from the first study should be out in the first quarter of 2015. BioDelivery Sciences further stated that it will conduct another long-term safety study in patients suffering from painful diabetic neuropathy as a part of the overall clinical program for clonidine.
We note that clonidine might be granted priority review status by the FDA due to its fast track designation. BioDelivery Sciences intends to file a new drug application (:NDA) for clonidine in 2016.
BioDelivery Sciences currently has another late stage candidate in its pipeline. The company is evaluating BEMA buprenorphine (moderate to severe chronic pain) in collaboration with Endo (ENDP). Top-line results from this study should be out by mid-2014 with a NDA filing slated for later this year or early next year.
Meanwhile, BioDelivery Sciences has an important regulatory event coming up with the U.S. Food and Drug Administration (:FDA). The FDA is expected to deliver a response regarding the approvability of Bunavail for the treatment of opioid dependence. The FDA action date is Jun 7, 2014. If approved, the company expects to launch Bunavail in the third quarter of 2014.
We expect investor focus to remain on Bunavail’s approval status.
BioDelivery Sciences carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceutical sector include Questcor Pharmaceuticals, Inc. (QCOR) and Shire plc (SHPG). Both stocks carry a Zacks Rank #1 (Strong Buy).