BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Files An 8-K Other Events
Item8.01.
| Other Information. |
On December13, 2016, BioDelivery Sciences International, Inc.
(the Company) issued a press release announcing that its Phase 2b
clinical study assessing the efficacy and safety of Clonidine
Topical Gel for the management of painful diabetic neuropathy
failed to show a statistically significant difference in pain
relief between Clonidine Topical Gel and placebo. 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 December13, 2016, announcing the results of the Companys Phase 2b study of Clonidine Topical Gel. |
Cautionary Note Regarding Forward-Looking
Statements
This Current Report on Form 8-K, the press release included
herein, the conference call referenced in such press release, 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 commercialization efforts for the
Companys approved products and the clinical trials for, and
regulatory review of, the Companys products in development) 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 1.90 with 2,119,984 shares trading hands.
