Carcinoid Syndrome Treatment Application Submitted to FDA

Lexicon Pharmaceuticals Inc has submitted a new drug application (NDA) for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome.

The FDA will have till the end of May to determine if the application is complete and acceptable. In addition to submitting an NDA, Lexicon requested priority review for telotristat etiprate.

Existing treatments for carcinoid syndrome can reduce serotonin production outside of tumor cells. Telotristat etiprate, on the other hand, can reduce serotonin production within the tumor cells, thus hindering a key driver of the disease, according to Lexicon.

“The filing of the NDA for telotristat etiprate brings us one step closer to the possibility of bringing this innovative new investigational treatment to the market to improve the lives of the community of patients and caregivers who live with carcinoid syndrome on a daily basis,” said Lexicon President and CEO Lonnel Coats in a press release. “We look forward to working closely with the FDA during the review process.”

The NDA is based on results from 2 phase 3 clinical trials that found that the drug could significantly reduce urinary 5-hydroxyindoleacetic acid, as well as average number of daily bowel movements over a 12-week study period.

Carcinoid syndrome is a rare disease that affects some cancer patients with metastatic neuroendocrine tumors that have spread to the liver and other organs from the gastrointestinal tract.