Posts tagged ‘TSPT’

Transcept INTERMEZZO PDUFA Date

Transcept Pharmaceuticals (TSPT) is getting ready for it’s third Annual PDUFA Date coming up for INTERMEZZO for insomnia on Nov 27, 2011.  I think the results will be the same.  Why?  Because if you keep doing the same thing (submit NDAs with the same data) you can expect to get the same result – NFC from the FDA – Not Favorably Considered.

The FDA told them they had a problem with the dose in women, ie, it might be too high and there might be some carry over effects upon awakening that could present a problem.  In other words, the benefit risk ratio was tilted in the direction of risk.  So, the company lowers the dose in women by half, reducing the risk.  But what about the benefit side of the equation if you reduce the dose by half?  I don’t think they have the adequate and well controlled study on that.  So, we’ll probably get a chance to comment on this again next year when they celebrate their Fourth Annual PDUFA Date for this drug.

Intermezzo PDUFA Date Action

Transcept Pharma (TSPT) reported that FDA issued a Complete response letter  to their resubmission of Intermezzo, a drug indicated for use in treating night time awakening insomnia.  The original NDA was submitted in 2008 and not favorably considered by the FDA because of concerns they had about driver impairment.  The company reported they did a driver impairment study and resubmitted the NDA.  The most recent PDUFA Date was July 14, 2011.

Transcept has reported that the second CRL still has questions about driver impairment.  This doesn’t look good for Intermezzo.  Either the second driver impairment study was inadequate in design (unlikely if the FDA had input and the company followed the FDA input), or it showed driver impairment.  Either case, it looks like another redo of the study.