BioDelivery Sciences to start clinical work on BEMA LA, plans phase 3 trial in second half of 2006

New York, Nov. 28 - BioDelivery Sciences International, Inc. said that it plans to start clinical development of its BEMA Long Acting Analgesic (LA) product in the first quarter of 2006 and to begin phase 3 trials in the second half of next year.

The announcement follows a meeting with the Food and Drug Administration to discuss the regulatory pathway and development plan for BioDelivery Sciences' BEMA LA. At the meeting, the FDA gave a preliminary indication that the company will be able to use the 505(b)(2) regulations for submission of a New Drug Application for BEMA LA, BioDelivery Sciences said in a news release.

The 505(b)(2) process is designed to address new delivery formulations of drugs previously approved by the FDA. As a result, BioDelivery Sciences believes it has the potential to be more efficient and less time consuming than other FDA approval methods.

BEMA LA is BioDelivery Sciences' second product to use the company's BEMA delivery system.

BioDelivery Sciences is initially developing BEMA LA for the acute treatment of moderate to severe pain, such as post-operative pain. It will use an analgesic that is already FDA approved and is substantially more potent than morphine, but which BioDelivery Sciences believes has a lower risk of opioid related side effects. The company noted that the proposed analgesic is a class 3 narcotic, which means that it has been classified as having less abuse and addiction potential than class 2 narcotics such as morphine.

"Although final FDA approval of our products and formulations can not be guaranteed, the FDA's receptiveness to our regulatory approval strategy is, we believe, a significant validation of a critical component of our business model," said BioDelivery Sciences president and chief executive officer Mark A. Sirgo in a news release.

BioDelivery Sciences' BEMA drug delivery system is a dissolvable, dime-sized polymer disc that is applied to the inside of the cheek. The company is based in Morrisville, N.C.

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