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.