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Last $5.90 USD
Change Today +0.49 / 9.06%
Volume 1.4M
As of 8:10 PM 10/2/15 All times are local (Market data is delayed by at least 15 minutes).

biodelivery sciences intl (BDSI) Snapshot

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10/31/14 - $18.33
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09/29/15 - $4.66
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biodelivery sciences intl (BDSI) Details

BioDelivery Sciences International, Inc., a specialty pharmaceutical company, engages in the development and commercialization of pharmaceutical products principally in the areas of pain management and addiction. 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. It offers ONSOLIS, a fentanyl buccal soluble film to treat breakthrough pain in opioid patients with cancer marketed under the BREAKYL name in Europe and PAINKYL name in Taiwan; BUNAVAIL, a buprenorphine and naloxone buccal film for the treatment of opioid dependence; and BELBUCA for the treatment of chronic pain. The company also develops Clonidine Topical Gel, which is in Phase III clinical trial to treat painful diabetic neuropathy and other indications; and buprenorphine depot injection. It has a licensing and development agreement with Endo Pharmaceuticals, Inc.; Arcion Therapeutics, Inc.; Evonik Corporation; and Meda AB. BioDelivery Sciences International, Inc. was founded in 1997 and is headquartered in Raleigh, North Carolina.

29 Employees
Last Reported Date: 03/16/15
Founded in 1997

biodelivery sciences intl (BDSI) Top Compensated Officers

Chief Executive Officer, President, Executive...
Total Annual Compensation: $751.4K
Chief Financial Officer, Treasurer and Corpor...
Total Annual Compensation: $370.9K
Executive Vice President of Product Developme...
Total Annual Compensation: $434.2K
Compensation as of Fiscal Year 2014.

biodelivery sciences intl (BDSI) Key Developments

Endo Pharmaceuticals Inc. and Biodelivery Sciences International, Inc. Presents New Data on Investigational Product Buprenorphine HCI Buccal Film for Chronic Pain Management

Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. presented data from a Phase 2 study for the investigational drug buprenorphine HCl buccal film utilizing BDSI's patented BioErodible MucoAdhesive (BEMA®) drug delivery technology. The findings, presented in a poster session at PAINWeek 2015 in Las Vegas, showed that study participants receiving around-the-clock therapy with an opioid full agonist (morphine or oxycodone) could be switched to buprenorphine HCl buccal film, at approximately half the full agonist dose, without increasing the risk of experiencing opioid withdrawal or a loss of pain relief. These findings also will be presented later this month at the Annual Meeting of the American Academy of Pain Management in National Harbor, MD. Buprenorphine HCl buccal film is being developed under the proprietary name BELBUCA™ (buprenorphine HCl) buccal film and is currently under review by the U.S. Food and Drug Administration (FDA) for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The PDUFA action date is in October 2015. Buprenorphine HCl buccal film provides buprenorphine in an optimally-designed delivery system, which efficiently and conveniently delivers buprenorphine across the buccal mucosa (inside lining of the cheek). Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category which includes most opioid analgesics. The Phase 2, randomized, double-blind, active controlled, two-period crossover study included 39 chronic pain sufferers who were receiving 80 mg to 220 mg (80-160 mg, n=33; 161-220 mg, n=6) daily around-the-clock therapy of an opioid full agonist (either morphine sulfate or oxycodone HCl), and were confirmed to be opioid dependent. Approximately eight to twelve hours after the last full agonist dose, study subjects received buprenorphine HCl buccal film 300 or 400 mcg, which was calculated to be equivalent to 50% of their full agonist dose. The study also included an active-control group, who remained on 50% of their full agonist dose. The primary endpoint was the proportion of study participants that demonstrated significant withdrawal symptoms (a maximum Clinical Opiate Withdrawal Scale, or COWS, score of =13) or required rescue therapy because of these symptoms. Of the 35 study participants [31 on 80-160 mg and 4 on 161-220 mg morphine sulfate equivalent (MSE)/day] that completed both periods of the study, significant withdrawal was experienced in one study participant on buprenorphine HCl buccal film and two participants on the full agonist treatment arm. Mean maximum COWS scores were comparable for participants in the buprenorphine HCl buccal film group versus the full agonist group [in the 80-160mg MSE dose group: Mean (SD) 4.6 (3.15) vs. 5.3 (4.42), respectively; p=0.79; in the 161-220 mg MSE dose group, 5.5 (1.91) vs. 6.3 (2.50), p=0.62]. There was no significant difference in pain ratings between the buprenorphine and full agonist treatment groups for patients in the 80-160 mg MSE dose group. The sample size for patients in the higher dose (161 to 220 mg) group was too small to permit a rigorous statistical analysis or conclusions from the data. The COWS total scores indicate that these subjects were successfully switched between around-the-clock (ATC) opioid and buprenorphine in the dose range (80-220 mg MSE) without precipitating withdrawal issues. There was no evidence of a difference in precipitated opioid withdrawal following buprenorphine and ATC opioid administered twelve hours after a therapeutic dose of ATC opioid.

BioDelivery Sciences International, Inc. Secures Two-Year Contract with Tennessee Medicaid

BioDelivery Sciences International, Inc. secured a two-year contract with Tennessee Medicaid, also referred to as TennCare, making BUNAVAIL® (buprenorphine and naloxone buccal film, CIII) the only buprenorphine/naloxone treatment for opioid dependence with preferred coverage status on TennCare’s preferred drug list (PDL). Preferred coverage status for BUNAVAIL means that all patients will receive BUNAVAIL, with the exception that non-preferred products can be used only following trial and failure, contraindication or intolerance to the preferred product, BUNAVAIL.

BioDelivery Sciences International, Inc. Presents at Ladenburg Thalmann 2015 Healthcare Conference, Sep-29-2015 10:00 AM

BioDelivery Sciences International, Inc. Presents at Ladenburg Thalmann 2015 Healthcare Conference, Sep-29-2015 10:00 AM. Venue: Sofitel Hotel, New York, New York, United States.


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