Transcept: FDA Won't Need New Sleep-Drug Studies
POINT RICHMOND, Calif. (AP) - Transcept Pharmaceuticals Inc. said Wednesday that it does not expect to run any new clinical trials of its sleep drug Intermezzo and said Food and Drug Administration may be able to complete a new review of the drug within two months.
Transcept's stock spiked on optimism the drug might final be approved for marketing.
In July the FDA declined to approve Intermezzo because of concerns about its safety. Transcept said Wednesday that the FDA "generally agreed" with its plans to address those concerns.
Transcept proposed cutting the recommended dose of Intermezzo for women in half, to 1.75 milligrams, while the recommended dose for men will remain 3.5 milligrams. The company said it will also recommend that patients take the drug only if they have at least four hours of sleep remaining, and that patients should not drive within five hours of taking Intermezzo, or within an hour of waking up.
The company said it still plans to resubmit its marketing application by the end of September and said the FDA may be able to complete the review within two months. If companies submit a large amount of new data in response to an FDA request, the agency often takes six months to review the new submission.
Transcept wants to market Intermezzo as a treatment for people who wake late at night and cannot get back to sleep.
The drug has had a winding path in trying to get to market. The FDA previously rejected Intermezzo in October 2009, asking Transcept to run a highway driving study to provide more data about the drug's effects the following day.
Transcept said Tuesday that it had reached a general agreement with the FDA about its concerns. Shares of Transcept jumped 11.3 percent in Wednesday trading, and the stock climbed 52 cents, or 15.6 percent, to $3.86 after hours.
Posted: September 2011