Trade Resources Company News Lexicon Pharmaceuticals Has Won Fast Track Status From The US FDA

Lexicon Pharmaceuticals Has Won Fast Track Status From The US FDA

Lexicon Pharmaceuticals has won Fast Track status from the US FDA to develop LX1033, an orally-delivered small molecule drug candidate to treat diarrhea-predominant irritable bowel syndrome (IBS-d).

Fast Track facilitates the development and expedites the review of new drugs intended to serve unmet medical needs in serious or life-threatening conditions.

Lexicon Pharmaceuticals senior vice president and chief medical officer said Pablo Lapuerta said, "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."

Currently being evaluated in a Phase 2 clinical trial for IBS-d, LX1033 is an inhibitor of tryptophan hydroxylase (TPH) that functions in the gastrointestinal tract.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/us-fda-grants-fast-track-status-to-lx1033-241212
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Us Fda Grants Fast Track Status to Lx1033