BDSI to discuss planned BEMA Granisetron IND with the FDA

Jan 13 2010

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that the company has been granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned Investigational New Drug (IND) application for BDSI’s antiemetic (anti-nausea and vomiting) product candidate, BEMA Granisetron. The meeting will take place on March 17, 2010. The company will discuss with the FDA clinical development and regulatory plans for BEMA Granisetron, which is anticipated to enter Phase 1 studies in the second quarter of 2010.

“Patients experiencing nausea and vomiting often have difficulty taking oral medications. Additionally, absorption of drug from the gastrointestinal tract can be highly variable in these individuals”

“Patients experiencing nausea and vomiting often have difficulty taking oral medications. Additionally, absorption of drug from the gastrointestinal tract can be highly variable in these individuals,” said Dr. Andrew Finn, Executive Vice President, Product Development at BDSI. “Having a formulation of an antiemetic that does not require swallowing and gastric absorption could possibly lead to faster and more consistent blood levels of drug. We believe that such a product could have significant potential.”

BEMA Granisetron utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek) to deliver the FDA approved antiemetic drug granisetron (also known as Kytril^®, marketed by Genentech). Granisetron is known as a selective 5HT-3 receptor antagonist, which are the most widely used treatments for the prevention of nausea and vomiting related to chemotherapy and radiation. Sales of 5HT-3 antagonists exceeded $1.7 billion in 2008.

Based on the outcome of the discussion with FDA, Phase 3 development could occur as early as the beginning of 2011. BEMA Granisetron would be the third BEMA product to enter clinical development and follows the recent FDA approval of the first product to use the BEMA drug delivery technology, ONSOLIS (fentanyl buccal soluble film), for the treatment of breakthrough pain in opioid tolerant patients with cancer. The company also announced last month positive Phase 2 results for its latest pain product, BEMA Buprenorphine, a potential treatment for acute and chronic pain.