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FDA delay for new anti depressant

Posted by Robert Fairburn on November 26, 2003, at 4:19:52

Theres a new antidepressant thats in development called Nemifitide www.innapharma.com which is in stage 2/3 of trails. However this novel peptide antidepressant has been in the labs since 96. Why does its take so long for a drug to get fda approval. By the time this drug is released it will almost be 10 years from lab to pharmacy shelf. It will take even longer to reach people outside the USA. I know that the FDA needs to be careful but I can believe that its necessary for such long delays. I know thats AIDS patients have tahe the FDA to task over overtly long delays for approval. I cant see why it needs to take 3 years or more before approval is given. In the labs at the moment there are some interesting antidepressants in development however it will take 10 years before we will be able to buy them. Our present range of drugs are very poor. In terms of total response rate MAOI drugs are still best. Some of these drugs where approved in the 1950's. Yet in the year 2003 we have nothing better in regards to the percentage of people who respond to a antidepressant. We have a better selection of drugs, but in reality we just a better selection of poor to average. It looks like we have to wait a while longer before theres any improvement in the situation.

Regards Robert


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poster:Robert Fairburn thread:283941
URL: http://www.dr-bob.org/babble/20031126/msgs/283941.html