Lexicon Pharmaceuticals IBS Drug Gets on FDA Fast Track
Biotech Lexicon Pharmaceuticalsannounced Monday that the Food and Drug Administration has given "fast track" status to Lexicon's LX1033 drug to treat diarrhea-predominant irritable bowel syndrome (IBS-d).
The FDA's fast-track process facilitates the development of a drug and accelerates the regulatory review of a drug once it has completed clinical trials. Drugs specified for fast-track status may serve a patient population with limited alternative options, treat critical or life-threatening conditions, or meet various other criteria.
Lexicon Chief Medical Officer and Senior Vice President Dr. Pablo Lapuerta said in the company's press release: "We are pleased with the FDA's grant of Fast Track status for LX1033 in IBS-d, recognizing this important area of unmet medical need and the potential benefits that LX1033 could provide for those suffering from this disease."
LX1033, which acts to combat IBS by inhibiting tryptophan hydroxylase in the gastrointestinal tract, is currently in phase 2 trials.
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