* Plans to resubmit NDA in Q1 2011
* Follows highway driving study
* Sees a six-month review by the FDA
Oct 19 (Reuters) - Transcept Pharmaceuticals Inc plans to resubmit a new drug application (NDA) with U.S. regulators for its sleep-disorder drug Intermezzo after a study showed no significant effect on driving after four hours.
Transcept said in a statement it plans to resubmit the NDA in the first quarter of 2011 and expects a six-month review by the U.S. Food and Drug Administration.
The FDA had declined to approve Intermezzo in October last year and sought additional data to show the drug, when taken in the middle of the night, would not present any risk, particularly related to driving ability.
The company plans to address FDA concerns by submitting the results of a highway driving study that indicated Intermezzo showed no significant effect on performance in volunteers who began driving an automobile four hours after receiving a middle-of-the-night dose.
The company also said it planned to submit a revised unit dose package, new patient tools to reinforce the importance of proper dosing and data to quantify the current off-label use.
Shares of the company closed at $6.61 Monday on Nasdaq.
(Reporting by Anand Basu in Bangalore; Editing by Hans Peters) Keywords: TRANSCEPTPHARMA/ (anand.basu@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: anand.basu.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* Follows highway driving study
* Sees a six-month review by the FDA
Oct 19 (Reuters) - Transcept Pharmaceuticals Inc plans to resubmit a new drug application (NDA) with U.S. regulators for its sleep-disorder drug Intermezzo after a study showed no significant effect on driving after four hours.
Transcept said in a statement it plans to resubmit the NDA in the first quarter of 2011 and expects a six-month review by the U.S. Food and Drug Administration.
The FDA had declined to approve Intermezzo in October last year and sought additional data to show the drug, when taken in the middle of the night, would not present any risk, particularly related to driving ability.
The company plans to address FDA concerns by submitting the results of a highway driving study that indicated Intermezzo showed no significant effect on performance in volunteers who began driving an automobile four hours after receiving a middle-of-the-night dose.
The company also said it planned to submit a revised unit dose package, new patient tools to reinforce the importance of proper dosing and data to quantify the current off-label use.
Shares of the company closed at $6.61 Monday on Nasdaq.
(Reporting by Anand Basu in Bangalore; Editing by Hans Peters) Keywords: TRANSCEPTPHARMA/ (anand.basu@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: anand.basu.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.