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biodelivery sciences intl (BDSI) Details

BioDelivery Sciences International, Inc., a specialty pharmaceutical company, develops and commercializes therapeutics in the areas of pain management and oncology supportive care. The company provides its products based on its patented BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, bi-layered erodible polymer film for application to the buccal mucosa. Its products include ONSOLIS, a fentanyl buccal soluble film for the management of breakthrough pain in patients with cancer; and BEMA Buprenorphine that is in Phase III trial for the treatment of chronic pain in a mixed opioid naïve and opioid experienced population. The company is also involved in the development of BUNAVAIL for the maintenance treatment of opioid dependence; and Clonidine Topical Gel for the treatment of painful diabetic neuropathy. It has a licensing and development agreement with Endo Pharmaceuticals, Inc. to develop and commercialize BEMA Buprenorphine; and license agreement with Arcion Therapeutics. The company was founded in 1997 and is headquartered in Raleigh, North Carolina.

24 Employees
Last Reported Date: 03/14/14
Founded in 1997

biodelivery sciences intl (BDSI) Top Compensated Officers

Chief Executive Officer, President, Chief Sci...
Total Annual Compensation: $739.3K
Executive Chairman and Member of Executive Su...
Total Annual Compensation: $368.7K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $61.2K
Executive Vice President of Product Developme...
Total Annual Compensation: $438.2K
Senior Vice President of Finance and Treasure...
Total Annual Compensation: $432.1K
Compensation as of Fiscal Year 2013.

biodelivery sciences intl (BDSI) Key Developments

Endo and Biodelivery Sciences Announce Results from the Phase III Clinical Trial of BEMA(R) buprenorphine in Opioid-experienced Patients with Chronic Pain

Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. announced positive top-line results from its pivotal Phase III efficacy study of BEMA buprenorphine in opioid-experienced patients. BEMA buprenorphine is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in both patients who are opioid naive and opioid experienced. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly (p<0.0001) improved chronic pain relief compared to placebo. Additional secondary endpoints were supportive of the efficacy of BEMA buprenorphine compared to placebo. The most commonly reported adverse events in patients treated with buprenorphine compared to placebo were nausea (7.5% vs. 7.4%) and vomiting (5.5% vs. 2.3%). About the Phase III BEMA buprenorphine trial in opioid-experienced patients. The Phase III clinical trial was an enriched-enrollment, double-blind, randomized withdrawal study to evaluate the efficacy and safety of BEMA buprenorphine in the treatment of chronic lower back pain in opioid-experienced patients. A total of 511 patients who titrated to a well-tolerated, effective dose were randomized to either continue on that dose of BEMA buprenorphine, or receive placebo (BEMA film with no active drug), with treatment continuing for 12 weeks. The primary efficacy endpoint was the mean change in the daily average pain numerical rating scale (NRS-Pain) scores from baseline (just prior to randomization) to week twelve of the double-blind treatment period. Pain was self-reported daily on an 11-point numeric rating scale (daily NRS; 0=no pain, 10=worst possible pain).

BioDelivery Sciences International, Inc. Finishes Enrollment of Patients for its Initial Phase 3 Study of Clonidine Topical Gel for the Treatment of Painful Diabetic Neuropathy

BioDelivery Sciences International, Inc. announced that it has finished enrollment of patients for its initial Phase 3 study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy or PDN. The Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with PDN. In the trial, referred to as the RHAPSODY Study, 140 adult patients are randomized to receive either Clonidine Topical Gel or a placebo gel, over a period of 12 weeks. This is the first of two studies, based on which the company would file a New Drug Application to the U.S. Food and Drug Administration or FDA. FDA has granted Fast Track designation for the program, which recognizes the need of developing new therapies for this serious condition. The company is now rolling over patients from the first Phase 3 trial into the 12-month long-term safety study and expects to begin the second study in the first quarter of next year. The overall program is being conducted in patients showing functional skin nociceptors, which is the population of patients that demonstrated a statistically significant difference compared with placebo on the primary efficacy endpoint in a previously conducted Phase 2 study.

BioDelivery Sciences International, Inc. Presents at 2014 Wells Fargo Healthcare Conference, Jun-17-2014 04:40 PM

BioDelivery Sciences International, Inc. Presents at 2014 Wells Fargo Healthcare Conference, Jun-17-2014 04:40 PM. Venue: InterContinental Hotel Boston, 510 Atlantic Avenu, Boston, MA 02210, United States.


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