Aug. 12, 2014
/PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that along with its commercial partner, Endo Pharmaceuticals, engaged in a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The meeting was held on
and meeting minutes have been received.
The positive outcome of the pre-NDA meeting allows BDSI and Endo to maintain expectations of an NDA filing with FDA for BEMA Buprenorphine in late 2014 or early 2015 as planned.
The scheduled meeting with FDA regarding the NDA submission for BEMA Buprenorphine was undertaken to review the key data elements for the NDA and follows the successful completion of two Phase 3 clinical studies of BEMA Buprenorphine. Both studies yielded positive top-line results and demonstrated that BEMA Buprenorphine significantly improved chronic pain relief compared to placebo in a study of opioid naive patients (p<0.005) and in a study of opioid experienced patients (p<0.0001). Secondary endpoints were also supportive of the efficacy.
"We are pleased to be progressing another product toward an NDA submission," said Dr.
, Executive Vice President of Product Development. "We will continue to work closely with our partner Endo Pharmaceuticals as they prepare the NDA submission for late this year or early next year."
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine. BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA
) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.
BDSI's development strategy focuses on utilization of the FDA's 505(b)(2) approval process. This regulatory pathway creates the potential for more timely and efficient approval of new formulations of previously approved therapeutics.