BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Files An 8-K Other Events
Item8.01.
| Other Information. |
On April2, 2017, BioDelivery Sciences International, Inc. (the
Company) issued a press release announcing that the U.S. Food and
Drug Administration has approved a Supplemental New Drug
Application (sNDA) for BUNAVAIL (buprenorphine and naloxone)
buccal film (CIII) revising the indication to include the use of
BUNAVAIL for the initiation of buprenorphine treatment for opioid
dependence. A copy of the press release is attached as Exhibit
99.1 hereto.
| Item9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| 99.1 |
Press release, dated May2, 2017, announcing Supplemental New Drug Application (sNDA) approval for BUNAVAIL. |
Cautionary Note Regarding Forward-Looking
Statements
This Current Report on Form 8-K, the press release included
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 Companys plans, objectives, projections,
expectations and intentions and other statements identified by
words such as projects, may, will, could, would, should,
believes, expects, anticipates, estimates, intends, plans,
potential or similar expressions. These statements are based upon
the current beliefs and expectations of the Companys management
and are subject to significant risks and uncertainties, including
those detailed in the Companys filings with the Securities and
Exchange Commission. Actual results (including, without
limitation, the results of the Companys commercialization
initiatives for BUNAVAIL and the Companys other products) may
differ significantly from those set forth in the forward-looking
statements. These forward-looking statements involve certain
risks and uncertainties that are subject to change based on
various factors (many of which are beyond the Companys control).
The Company undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
applicable law.
About BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company. The Company develops and commercializes, either on its own or in partnerships with third parties, applications of approved therapeutics to address unmet medical needs using drug delivery technologies. The Company develops pharmaceutical products aimed principally in the areas of pain management and addiction. The Company’s products utilize the BioErodible MucoAdhesive (BEMA) drug delivery technology, a small, erodible polymer film for application to the buccal mucosa (the lining inside the cheek). The Company’s United Sates Food and Drug Administration (FDA) approved product, ONSOLIS (fentanyl buccal soluble film), as well as its approved products BUNAVAIL (buprenorphine and naloxone buccal film) buccal film and BELBUCA (buprenorphine) buccal film, utilize BEMA technology. BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Recent Trading Information
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) closed its last trading session down -0.05 at 1.70 with 266,357 shares trading hands.