Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain

Endo Pharmaceuticals Inc., a subsidiary of Endo International plc

, and BioDelivery Sciences International, Inc.

announced today that they have submitted a New Drug Application (NDA) for Buprenorphine HCl Buccal Film to the U.S. Food and Drug Administration (FDA). Buprenorphine HCl Buccal Film is under development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The drug uses BDSI's patented BioErodible MucoAdhesive (BEMA®) drug delivery technology to efficiently and conveniently deliver buprenorphine across the buccal mucosa (inside lining of the cheek). Buprenorphine, a Schedule III controlled substance, is a partial opioid agonist and a potent analgesic with a relatively long duration of action. Buprenorphine HCl Buccal Film is being developed and will be commercialized through a worldwide license and development agreement between Endo Pharmaceuticals and BDSI. "Buprenorphine HCl Buccal Film is Endo's lead development program for our branded pharmaceuticals business representing a potentially important addition to our portfolio of pain medicines," said Rajiv De Silva, President and CEO of Endo. "Today's NDA filing is a significant step forward in our effort to address a need among patients suffering chronic pain. As a leader in the treatment of chronic pain, Endo has extensive experience supporting patients and their physicians, and look forward to continuing that commitment with Buprenorphine HCl Buccal Film." The two pivotal phase 3 studies for demonstration of safety and efficacy were double-blind randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. One study (BUP-307) was conducted in opioid experienced subjects, and the second study (BUP-308) was conducted in subjects naïve to opioid therapy. Both studies met the primary efficacy endpoint of change from baseline to week 12 of mean daily pain intensity score from placebo (BUP- 307; p <.00001 ; BUP – 308; p= .001 ). Buprenorphine HCl Buccal Film was generally well tolerated demonstrating a low incidence of typical opioid like side effects. "The submission of the NDA for Buprenorphine HCl Buccal Film is a major milestone in BDSI's partnership with Endo Pharmaceuticals," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "Buprenorphine's role in pain management in the United States has always been hampered by the lack of a convenient and flexible dosage form. We believe our patented BEMA technology will overcome this obstacle and provide physicians with a meaningful product to treat chronic pain. We look forward to continuing our work with Endo, and making this therapy available to patients who need it."