BioDelivery Sciences International, Inc. announced cash flow results for the first quarter ended March 31, 2013. For the quarter, the company reported cash used in operations totaled $13.5 million. In 2013, the company is focusing its resources on achievement of the milestones: Based on demonstrating bioequivalence in the pivotal pharmacokinetic study and positive results in the safety study, the company anticipates it will submit an NDA to the FDA for BUNAVAIL in mid-summer 2013. The company will continue to evaluate its strategic options for the commercialization of BUNAVAIL, which include partnership, internal approaches or a combination of these. The company expects to finalize its strategy in the second half of 2013. The company and Endo expect to continue recruitment in the two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naïve patient groups. The trials are expected to complete in late 2013 or early 2014. Upon completion of study enrollment and database lock for each trial, and the acceptance of filing of the NDA with the FDA, the company is expected to receive milestone payments from Endo totaling $30 million. The company plans to prepare for a confirmatory study in the latter part of 2013 which could lead to data availability by the end of 2014. The company and its commercial partner Meda submitted a proposal to FDA to reintroduce ONSOLIS for the treatment of breakthrough cancer pain into the U.S. marketplace following previously reported appearance issues with the product. If approved by FDA, the original ONSOLIS formulation may be on the market during the second-half of 2013 while stability data is collected on a newly formulated version of ONSOLIS. These data may be submitted to FDA before the end of the year, and if approved, could allow introduction of the new formulation sometime in 2014. In addition to advancing its lead products in development, the company is also, as in the past, exploring the application of its BEMA drug delivery technology to additional pharmaceuticals. In addition, the company continues to investigate potential new products and technologies to complement and diversify its existing portfolio.

BioDelivery Sciences International, Inc. announced the appointment of Thomas W. D'Alonzo to the company's Board of Directors. Mr. D'Alonzo previously served on the BDSI Board of Directors from August 2006 through June 2008.

BioDelivery Sciences International, Inc. announced that it has entered into a worldwide licensing agreement with privately held Arcion Therapeutics, where BDSI will develop and commercialize topical clonidine gel (formerly ARC4558) for the treatment of painful diabetic neuropathy (PDN) and potentially other indications.