One year after the FDA sent Transcept Pharmaceuticals (TSPT) back to the clinic to further test the safety of its sleep drug Intermezzo, the developer has come back with a set of fresh data from a new trial that it hopes can convince regulators to offer a green light on marketing.
In the fall of 2009, the FDA was worried that Intermezzo, a sleep drug designed for use by people who wake up in the middle of the night and have a hard time going back to sleep, could impair a person's driving ability when they head out of the house the next morning. So Transcept recruited 40 volunteers, dosing them at three and four hours prior to wakening. At four hours--the FDA's target outlined in the complete response letter--drivers were not impaired. At three hours after dosing, however, an analysis found a "statistically significant drug effect."
"If approved by the FDA, these results will further differentiate Intermezzo from other sleep aids by providing physicians and their patients with important safety information from what we believe to be the largest highway driving study of its kind," CEO Glenn Oclassen says. "This study is a central component of our broader resubmission strategy to address the concerns expressed by the FDA in the October 2009 Complete Response Letter."
Transcept has every reason to push for an approval as quickly as it can. Under a licensing pact, Purdue Pharmaceuticals cuts its $30 million approval milestone by $2 million a month for every month it's delayed past the end of June 2010. Now Transcept will have to wait a painfully long time to see if it has provided regulators all the safety data that it will need for an approval. An NDA goes out in the first quarter of 2011 followed by six months of review time.
- read the Transcept release on the data
- see the Reuters story