03.03.08
Wyeth Pharmaceuticals received approval from the FDA for Pristiq, a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD). Wyeth expects to begin shipping the drug to wholesalers in 2Q08.
"We are pleased to be able to bring Pristiq to patients," says Bernard Poussot, president and chief executive officer of Wyeth. "Pristiq is Wyeth's fourth new drug to receive approval in the last 12 months, demonstrating our ability to achieve success through the rigorous scientific process of discovery and development. We look forward to working with FDA and other regulatory authorities around the world to continue to bring important new medicines to patients who need them."
FDA approval was subject to several post-marketing commitments, including submitting long-term maintenance study data, a sexual dysfunction study, pediatric studies and a study exploring lower doses. The agency also requested an additional non-clinical toxicity study.
Efficacy of Pristiq as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, studies in adult patients with MDD. The most common adverse reactions in patients taking Pristiq for MDD in short-term, fixed-dose studies (incidence greater than or equal to 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, sleepiness, decreased appetite, anxiety, and specific male sexual function disorders.
"We are pleased to be able to bring Pristiq to patients," says Bernard Poussot, president and chief executive officer of Wyeth. "Pristiq is Wyeth's fourth new drug to receive approval in the last 12 months, demonstrating our ability to achieve success through the rigorous scientific process of discovery and development. We look forward to working with FDA and other regulatory authorities around the world to continue to bring important new medicines to patients who need them."
FDA approval was subject to several post-marketing commitments, including submitting long-term maintenance study data, a sexual dysfunction study, pediatric studies and a study exploring lower doses. The agency also requested an additional non-clinical toxicity study.
Efficacy of Pristiq as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, studies in adult patients with MDD. The most common adverse reactions in patients taking Pristiq for MDD in short-term, fixed-dose studies (incidence greater than or equal to 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, sleepiness, decreased appetite, anxiety, and specific male sexual function disorders.