Wyeth still sees Q3 launch of drug for hot-flashes
NEW YORK, April 19 (Reuters) - Wyeth WYE.N on Thursday said it still expects in the third quarter to launch its Pristiq drug in the United States to treat hot flashes, despite the need by regulators to review favorable data from new low-dose trials of the medicine.
Company officials told analysts on a conference call that very few women taking the low 50-milligram dose of Pristiq dropped out of recent hot-flashes trials due to nausea and other side effects seen in prior trials that involved higher doses. Nausea was "markedly lower" in the new trials, Wyeth said.
Wyeth said data showing effectiveness but better tolerability of the low dose will be submitted to the U.S. Food and Drug Administration and make Pristiq more attractive to doctors and patients.
The company said the 50-milligram dose of Pristiq was also effective in separate trials against depression and better tolerated than higher doses studied in prior depression trials. Based on the new data, Wyeth said the 50-milligram dose will likely be an adequate strength as an anti-depressant.
Because the FDA will also need to review the data from the low-dose trials against depression, Wyeth said it does not expect approval for that condition until the first quarter of 2008. It had previously forecast a launch by late 2007 or early 2008.
((Reporting by Ransdell Pierson, editing by Gerald E. McCormick; Reuters Messaging: ransdell.pierson.reuters.com@reuters.net; 646-223-6034; ransdell.pierson@reuters.com)) Keywords: WYETH PRISTIQ/LAUNCH
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