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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2014 Financials
Date:8/7/2014

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Earlier in the week, BDSI announced that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). The encouraging outcome reported in this interim analysis was performed on data from the first 50% of patients who completed the study. The purpose of the interim analysis was to allow for a sample size adjustment if necessary to maintain appropriate statistical power to detect a treatment effect between Clonidine Topical Gel and placebo. As a result of the interim analysis, a total of approximately 80 additional patients will be added to the ongoing trial in an effort to maintain 90% power to detect a statistically significant difference between Clonidine Topical Gel and placebo.  This will extend patient enrollment until year-end with top-line results expected by the end of the first quarter of 2015. This is the first of two pivotal trials that would be required for submission of an NDA to the FDA. The FDA has granted Fast Track designation for the program, which recognizes the need for developing new therapies for this serious condition.

At the end of the second quarter of 2014, BDSI had $88.4 million in cash, which includes the $10 million milestone payment from Endo which was collected in early July, compared to $37.4 million at June 30, 2013. BDSI's research and development costs were $8.0 million compared to a corresponding $12.8 million in the second quarter of 2013.  Year to date through June 30, 2014, research and development expenses were $22.6 million versus $24.8 million for the comparable six month period of 2013. The decrease in research and development expense was due primarily to the conclusion of the BEMA Buprenorphine Phase 3 trial in opioid naïve patients and the winding down of the opioid experienced study.  

SG&A expenses for the second quarter of 2014 were $7.2 million versus $3.1 mill
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SOURCE BioDelivery Sciences International, Inc.
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1. BioDelivery Sciences Provides Update on Ongoing Phase 3 Pivotal Trial for Clonidine Topical Gel for Painful Diabetic Neuropathy
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