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Wyeth submits follow-up to antidepressant blockbuster

Published on 20/01/06 at 11:48am

Wyeth has submitted its new antidepressant desvenlafaxine to the FDA, a drug it hopes will be a successor to its top-selling Efexor.

Desvenlafaxine is a metabolite of Efexor (venlafaxine) and is expected to maintain Wyeth's lucrative depression franchise in the face of generic competition.

In January, Wyeth announced that it had settled a US legal battle with Teva, which plans to market a generic extended release venlafaxine.

Efexor (including extended release version Efexor XL) is the number one selling and most-prescribed antidepressant globally, with final 12-month figures for 2005 expected to show around $4 billion in revenue worldwide.

The drug continues to grow strongly outside the US, but in its most important market, Efexor sales fell 4% in the third quarter. Wyeth said the drug's performance for the period reflected a slowdown in the overall antidepressant market, as well as pressure from increasing use of generics in the treatment area.

Analysts say these market conditions mean the new drug is unlikely to equal Efexor's excellent performance, but could still be a major blockbuster with peak sales forecast at around $2.5 billion.

Like Efexor, the drug is a serotonin/norepinephrine reuptake inhibitor and is effective against a broad range of physical, somatic and other symptoms associated with depression. The new drug has been produced in an extended release formulation, promising greater efficacy and safety.

According to pharmacokinetic studies in healthy volunteers presented last year, desvenlafaxine is safe when given at single doses up to 750mg. The research suggests that doses of the drug as high as 750mg seem to cause less severe nausea than extended release venlafaxine 150mg.

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