Transcept to conduct additional Intermezzo study
POINT RICHMOND, Calif. (AP) — Transcept Pharmaceuticals Inc. said late Wednesday that it will resubmit an application for its insomnia drug Intermezzo with the Food and Drug Administration after conducting an additional safety study.
The company said it will conduct a highway driving study to assess next day residual effects of the drug.
In October, the FDA told the company additional information would be needed to establish the safety of Intermezzo.
Transcept expects to begin enrollment in the study during the second quarter and submit the new application to the FDA during the fourth quarter.