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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Third Quarter 2013 Financials
Date:11/12/2013

lts from the opioid naive trial are expected in early 2014 and data from the opioid experienced trial will be available in mid-2014. 

Last month, the FDA announced that after careful evaluation it will be recommending to the U.S. Department of Health and Human Services (HHS) that hydrocodone combination products (e.g., Vicodin, Lortab, hydrocodone/APAP) be reclassified as Schedule 2 controlled substances.  This rescheduling will tighten restrictions around the use of hydrocodone combination products, which in 2012 alone accounted for nearly 130 million prescriptions.  Unlike Schedule 2 products, Schedule 3 products such as buprenorphine do not require a written prescription and can be prescribed with refills.  The importance to BDSI of the rescheduling of hydrocodone containing products is that it may provide an opportunity for BEMA Buprenorphine to reach its upside peak sales forecast.  

In addition, BDSI reported it will initiate a Phase 2B clinical trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy in first quarter of 2014.  Clonidine has been shown to stimulate an inhibitory receptor in the skin associated with pain fibers.  Currently there is no topical product approved to treat this condition.

In July 2013, BDSI completed a $20 million debt financing with an affiliate of MidCap Financial.  At September 30, 2013, BDSI had $38.3 million in cash compared to $31.3 million at September 30, 2012.  Research and development costs were $16.4 million in the third quarter of 2013, compared to a corresponding $12.5 million in the third quarter of 2012.  The current quarter increase over the prior year third quarter is due primarily to additional research and development costs associated with the BUNAVAIL and the BEMA Buprenorphine late stage development programs.  Through the nine months ended September 30, 2013, research and development costs were $41.2 million
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SOURCE BioDelivery Sciences International, Inc.
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