BioDelivery Sciences Submits NDA For BUNAVAIL - Quick Facts

(RTTNews) - BioDelivery Sciences International, Inc. (BDSI), yesterday, submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for BUNAVAIL for the maintenance treatment of opioid dependence. According to the 505(b)(2) regulatory statute, BUNAVAIL would be subject to a ten-month review.

BUNAVAIL uses BDSI's patented BioErodible MucoAdhesive or BEMA drug delivery technology to deliver buprenorphine across the buccal mucosa. BUNAVAIL is formulated with the abuse deterrent agent naloxone and is designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms.

Mark Sirgo, President and Chief Executive, stated: "With our NDA filed we will continue to evaluate our strategic options for the commercialization of BUNAVAIL in the U.S., which include partnership, internal approaches or a combination of these. We will provide updates on our strategic direction as the year progresses."

The BUNAVAIL program, as agreed upon with FDA, included a bioequivalence trial to Suboxone tablets and a study assessing the safety and tolerability of BUNAVAIL in opioid dependent subjects switched from Suboxone film or tablets to BUNAVAIL.