Transcept Pharmaceuticals, Inc has announced its plan for the resubmission for the Intermezzo New Drug Application (NDA) based on a teleconference with the US Food and Drug Administration (FDA) held recently. The key component of the resubmission plan is an Intermezzo highway driving study to assess next day residual effects, for which Transcept now expects to begin enrolment in the late second quarter of 2010. Based on the teleconference with US FDA, and pending a positive highway driving study outcome, Transcept estimates that it will resubmit the Intermezzo NDA in the late fourth quarter of 2010.
In the October 28, 2009 Intermezzo Complete Response Letter, the US FDA expressed two concerns regarding the possibility of middle of the night patient dosing errors that could lead to next day residual effects, with particular reference to next day driving impairment. Specifically, the US FDA asked Transcept to address methods to avoid inadvertent re-dosing in a single night, and inadvertent dosing with less than four hours of bedtime remaining.
A meeting was held on January 20, 2010 to discuss the Intermezzo Complete Response Letter, during which the US FDA indicated that the Transcept proposal to employ a single unit dose package appeared to reduce the potential for inadvertently taking more than one Intermezzo dose in a single night.
During the March 24, 2010 teleconference, the US FDA agreed that the Transcept proposal submitted on February 16, 2010 to conduct a highway driving study is a reasonable way to measure potential next day driving impairment as a result of dosing Intermezzo in the middle of the night with four hours or less remaining in bed. This study will be conducted at the University of Maastricht in the Netherlands, a leading center of research on the effects of drugs and alcohol on driving performance.
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience.