two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada
, E.U. (where it is marketed as BREAKYL) and Taiwan
(where it is marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan
(licensed to TTY Biopharm) and South Korea
(licensed to Kunwha Pharmaceutical Co.).
BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo. Clonidine Topical Gel for the treatment of painful diabetic neuropathy is entering Phase 3 development.
An NDA for BUNAVAIL, a BEMA formulation of buprenorphine used in combination with naloxone, is currently under review for the maintenance treatment of opioid dependence and has a PDUFA date of June 7, 2014.
BDSI's headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.
Cautionary Note on Forward-Looking Statements
This press release, the presentation referred to herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will,
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. BioDelivery Sciences to Present at the 25th Annual Piper Jaffray Healthcare Conference2
. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Third Quarter 2013 Financials3
. BioDelivery Sciences to Present at the Stifel Nicolaus 2013 Healthcare Conference4
. Endo and BioDelivery Sciences Provide Update on BEMA Buprenorphine Phase III Development Program5
. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2013 Financials6
. BioDelivery Sciences Announces Submission of NDA for BUNAVAIL7
. BioDelivery Sciences Announces the Hiring of Adrian Hepner, M.D. as Vice President of Clinical Research & Regulatory Affairs8
. BioDelivery Sciences to Present at the William Blair 33rd Annual Growth Stock Conference9
. BioDelivery Sciences to Present at the Jefferies 2013 Global Healthcare Conference10
. BioDelivery Sciences to Present at the Bank of America Merrill Lynch 2013 Health Care Conference11
. BioDelivery Sciences Appoints Thomas W. DAlonzo to Board of Directors