US PANEL BACKS B-MS' SERZONE
Bristol-Myers Squibb's Serzone (nefazodone) is safe and effective in the treatment of depression, but questions still remain unanswered regarding the most appropriate dosage, according to the US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee.
B-MS' recommendation for the dose of nefazodone is an initial 200mg/day (100mg twice-daily) with a dosage increase for most patients based on their response to one week of therapy. Most of the responders in the eight clinical trials submitted in support of the application in the USA are being maintained on a dose of between 300 and 500mg/day.
Nefazodone is claimed to have a dual mode of action, combining 5-HT reuptake inhibition (the basis of the newer antidepressants such as Eli Lilly's fluoxetine), with blockade of 5-HT2 receptor sites.
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