DOR BioPharma, Inc announced that its programme for the development of DOR201 (oral beclomethasone dipropionate) for the prevention of acute radiation enteritis has received 'Fast Track' designation from the US Food and Drug Administration (FDA).
Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, DOR will be eligible to submit a new drug application (NDA) for DOR201 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which implies an abbreviated review time of six months.
"There are no FDA approved therapies to prevent acute radiation enteritis," stated Christopher J Schaber, president and chief executive officer of DOR. "The FDA's action in granting fast track designation is an indication of DOR201's potential to address this serious, unmet medical need with over 100,000 patients at risk annually. As the development program progresses, we look forward to working closely with the FDA to potentially expedite the development and NDA review process. The next step will be the initiation of the FDA cleared phase-1/2 clinical trial in the first half of 2009."
DOR201 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue.
DOR BioPharma is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.