Transcept plunges as FDA ask for more info on insomnia drug
This article was originally published in Scrip
Executive Summary
The US FDA has issued Transcept Pharmaceuticals with a complete response letter for its sleep drug, and lead candidate, Intermezzo (zolpidem tartrate sublingual tablet). The agency requested further safety data for the middle-of-the-night low-dose formulation of Sanofi-Aventis's Ambien.