Transcept Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration for Intermezzo®, the first sleep aid for use in the middle of the night.
Intermezzo is a low dose, buffered, sublingual formulation of zolpidem indicated for use as needed when patients awaken in the middle of the night and have difficulty returning to sleep. Intermezzo utilizes Transcept’s Bimucoral® technology in a mint-flavored, sublingual lozenge formulated to dissolve under the tongue in approximately 2 minutes. The NDA submission for Intermezzo follows two successful phase 3 clinical trials.
“The submission of the Intermezzo NDA achieves a key milestone for the Transcept team and advances our efforts to gain FDA approval for Intermezzo as the first sleep aid developed specifically to be used in the middle of the night when patients awaken and have difficulty returning to sleep,” says Glenn A. Oclassen, president and CEO of Transcept.
New Developments for Age-old Problems
Intermezzo Utilizes Lower Dose to Achieve Greater Early Bioavailability