FDA Accepts New Drug Application for Oral Carcinoid Syndrome Treatment

A new drug application (NDA) was submitted to the FDA for approval of the oral drug telotristat etiprate for patients with carcinoid syndrome.

The filing was based off results from the phase 3 clinical trial TELESTAR and its phase 3 companion study TELECAST.

The results of the TELESTAR study showed that the average number of daily bowel movements over the course of 12 weeks (p<0.001) had a statistically significant reduction from baseline compared with placebo, meeting the study’s primary endpoint.

At week 12 (p<0.001), the results of the TELECAST study showed a statistically significant reduction in urinary 5-hydroxyindoleacetic acid (5-HIAA) compared with placebo, which also achieved the primary endpoint.

“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 Chief Executive Officer Lonnel Coats. “We look forward to working closely with the FDA during the review process.”

Patients who experienced treatment-emergent adverse events, serious adverse events, and the discontinuation of treatment because of adverse events were found to be similar between the telotristat etiprate group and the placebo group.

The FDA has a 60 day filing review period to decide if the NDA is complete and acceptable for filing. Additionally, Lexicon has requested priority review as part of the NDA filing.