Lexicon Pharmaceuticals Submits New Drug Application for Telotristat Etiprate

Lexicon Pharmaceuticals has submitted a new drug application to the US Food and Drug Administration (FDA) for Telotristat Etiprate for the treatment of carcinoid syndrome.

For patients with carcinoid syndrome who are no longer responding to the current standard of care, the result of  TELESTAR, a Phase 3 study, was a decrease in daily bowel movements, some experiencing as high a percentage as 35% on a daily basis. According to neuroendocrine cancer specialist Dr. Matthew Kulke, principal investigator of the study, “These results clearly show telotristat etiprate represents a potentially promising new class of treatment for patients with carcinoid syndrome.” Lexicon Pharmaceuticals, based in Texas, received Fast Track designation and Orphan Drug status for telotristat etiprate from the U.S. Food and Drug Administration (FDA) in 2008 and 2012, respectively.

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