BioDelivery Sciences files FDA application for quick-dissolving pain drug formulation

By Angela McDaniels

Seattle, Jan. 6 - BioDelivery Sciences International Inc. said it has submitted an initial Investigational New Drug Application with the Food and Drug Administration for the company's BEMA Long-Acting Analgesic product.

BEMA LA is intended to meet the need for an alternative route of administration of an existing, marketed, FDA-approved narcotic for the treatment of moderate to severe pain. BEMA LA will be formulated using BioDelivery Sciences' licensed BEMA technology platform, which consists of a fast-dissolving mucoadhesive disc designed to rapidly deliver the active ingredient across the buccal mucosa of the mouth.

BioDelivery Sciences said the product will be a formulation of an analgesic that is substantially more potent than morphine but has a lower risk of serious adverse reactions and abuse.

BEMA LA was the subject of a pre-application meeting with the FDA in November 2005. The first human clinical trial will enroll healthy volunteers and compare the pharmacokinetics of the company's formulation to current formulations of the active ingredient.

BioDelivery Sciences believes that BEMA LA represents a substantial opportunity to capture market share in a pain market that generated reported 2004 sales of $21 billion and is estimated to grow to $29.8 billion by 2008. Due to the potential for BEMA LA to be used to treat a variety of pain conditions, the company estimated that the product could capture a 1% to 2% share of the total worldwide pain market and generate peak sales of between $250 million and $500 million.

BioDelivery Sciences is a specialty biopharmaceutical company based in Morrisville, N.C., that uses its drug delivery technologies to develop and commercialize new formulations of proven therapeutics targeted at acute conditions such as pain, anxiety, nausea and vomiting and infections.

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