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US APPROVES MENTRUAL MOOD DISORDER DRUG

The US Food and Drug Administration (FDA) has approved Eli Lilly’s Sarafem for women who experience prementrual dysphoric disorder (PMDD), or severe mood and physical symptoms during their menstrual cycles.

Lilly, based in Indianapolis, noted in a release that the active ingredient of Sarafem is fluoxetine hydrochloride, the sane active inredient found in Lilly’s anti-depressant Prozac.

Lilly spokesperson Jeff Newton told Reuters that compared with Prozac, Sarafem will be packaged differently, in four 7-day blister packs, the pills themselves eill be different colour and packaging will include educational materials to help patients understand the diagnosis and treatment of PMDD.

Clinical trials of Sarafem involved 500 women and lasted up to 6 months, Newton said. Lilly says that "in clinical studies, women treated with Sarafem experienced statistically significant improvement in mood and physical symptoms, as well as social functioning, compared with women taking (inactive) placebo."

The company adds that " these treatments are demonstrated by the first menstrual cycle on treatment."Safety data came from Prozac studies, Newton said. Adverse effects associated with Prozac may include fast talking and excited feelings, flu – like symptoms and irregular heartbeat.

(As reported in The Hindu Business Lines)