You can scratch another experimental depression drug off the list. Teva ($TEVA) today announced that it will dump its depression program for Nuvigil (armodafinil) after the treatment failed its latest Phase III test in a comparison against a placebo.
This was Teva's third Phase III study of Nuvigil for depression. Near the beginning of the year investigators for the company reported that the drug had flunked another late-stage showdown against a placebo. Faced with high, often hard-to-explain placebo responses in depression, drug companies are required to run multiple studies in search of positive data. The high cost and the extraordinary risk--which AstraZeneca ($AZN) can attest to as well--has caused several companies to steer clear of the field entirely.
"While this study demonstrated a numerical improvement, we are disappointed that armodafinil did not reach statistical significance. Teva remains committed to advancing science in serious conditions affecting the central nervous system," said Michael Hayden, Teva's president of global R&D.
The failure will have no material effect on the big generics company, according to the release, though the setback will do nothing to improve Teva's spotty record in R&D. Its cash cow Copaxone faces generic competition next spring, and analysts have been turning up the heat on the company to do something effective in terms of new product development. Nuvigil is already approved for excessive sleepiness.
- here's the press release
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