Endo Pharmaceuticals, a subsidiary of Endo International and BioDelivery Sciences International, Inc announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the companies' BELBUCA (buprenorphine HCl) buccal film 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.  FDA has indicated a standard review designation for the NDA and therefore the action date is expected 10 months from the NDA submission (October 2015).

Additionally, the FDA recently accepted BELBUCA as the proprietary name for (buprenorphine HCl) buccal film.

"Today's NDA acceptance represents an important step forward in our commitment to bringing to patients new therapeutic options for the treatment of chronic pain. We believe that BELBUCA is a significant advancement in pain care, and an important extension to Endo's portfolio of products," said Rajiv De Silva, President and CEO of Endo. "We look forward to working closely with the FDA and with our partner, BDSI, during this review period."

Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category which includes most opioid analgesics. Buprenorphine is a mu-opioid receptor partial agonist and a potent analgesic with a relatively long duration of action. BELBUCA is being developed and will be commercialised through a worldwide licence and development agreement between Endo Pharmaceuticals and BDSI.

"The FDA's acceptance of our BELBUCA NDA is a significant milestone for BDSI and in our partnership with Endo," said Dr. Mark A. Sirgo, President and CEO of BDSI. "We believe that BELBUCA can offer those suffering with chronic pain with a novel treatment approach. We look forward to continuing our work with Endo, and making this therapy available to patients who need it."  

Two pivotal Phase 3 studies were conducted to demonstrate the safety and efficacy of BELBUCA. The studies 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). BELBUCA was generally well-tolerated, demonstrating a low incidence of typical opioid like side effects.