Please login to the form below

Not currently logged in
Email:
Password:

FDA rejects Transcept's insomnia drug

The US Food and Drug Administration has told Transcept Pharmaceuticals its insomnia drug, Intermezzo, is not ready for marketing approval

The US Food and Drug Administration (FDA) has told Transcept Pharmaceuticals its insomnia drug, Intermezzo (zolpidem tartrate sublingual tablet), is still not ready for marketing approval after the company sent a second new drug application (NDA).

Prior to issuing a complete response letter (expected July 14), the agency held a teleconference with Transcept expressing continued concerns about the safety profile of the drug based on information provided by the company.

It is Transcept's intention that Intermezzo be used for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The company said: "After the complete response letter is received, Transcept will announce additional information on the content of the letter and the company's plans forthe future regulatory development of Intermezzo."

According to the Wall Street Journal, shares of Transcept were down 41 per cent at $5.11 in recent premarket trading.

13th July 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
McCann Health

The most globally awarded health agency network and currently Health Network agency of The Year. Comprising of two specialist agencies:...

Latest intelligence

Big data, privacy and the rise of genomic testing
Blue Latitude Health speaks to Johan Christiaanse, Marketing Director at BGI, to find out how the medical profession can overcome one of the major barriers to precision medicine – big...
Deal Watch January 2018
...
Emotional Intelligence and Blended Learning in Healthcare
EI and emotional selling are rising up the agenda when it comes to healthcare training. This article outlines how blended learning approaches can help put them into action....

Infographics