Lexicon Pharmaceuticals, Inc. Continues Recruiting for Phase 3 Studies in Carcinoid Syndrome

Many patients face the challenge of controlling carcinoid syndrome which can persist even while being treated with somatostatin analog (SSA) therapy. For patients on SSA therapy who continue to experience conditions such as diarrhea, frequent bowel movements, abdominal pain or flushing, the TELESTAR study is an option. TELESTAR is a global Phase III clinical study designed to evaluate the efficacy and safety of telotristat etiprate.

Lexicon Pharmaceutical's TELESTAR clinical study for carcinoid syndromeAdditionally, there is the Phase III clinical study, TELECAST, which offers another option for patients who have a documented history of carcinoid syndrome but do not meet the criteria for TELESTAR.

Telotristat etiprate is an investigational oral medication intended to treat carcinoid syndrome and its associated diarrhea, frequent bowel movements, abdominal pain and flushing. It is designed to reduce the ability of functioning carcinoid neuroendocrine tumors to produce serotonin by inhibiting tryptophan hydroxylase.

Currently being evaluated in a global Phase III development program, telotristat etiprate has received Fast Track designation from the US Food and Drug Administration (FDA) and Orphan Drug designation from both the FDA and the European Medicines Agency (EMA). The FDA’s Fast Track program facilitates the development of potential new drugs and expedites the review of new drugs intended to serve unmet medical needs in serious or life-threatening conditions.

FDA Orphan Drug Designation

According to the FDA, the Orphan Drug designation program “provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but not are not expected to recover the costs of developing and marketing a treatment drug.” The program also provides various incentives and preferences, such as seven years’ marketing exclusivity from the date of approval and certain tax advantages.

Travel assistance to the clinical site is available for patients and a loved one.

For more information about TELESTAR and TELECAST, Lexicon, or to find the clinical site closest to you, please visit http://www.lexpharma.com/clinicaltrials/telestar.html, call toll-free 1-855-897-0125, or email Lexicon at clinicalinfo@lexpharma.com.

Lexicon, a biopharmaceutical company founded in 1995, is dedicated to discovering and developing breakthrough treatments for human disease based on understanding how genes function.

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