Desvenlafaxine

Desvenlafaxine succinate, expected to be marketed under the name Pristiq, is an antidepressant of the serotonin-norepinephrine reuptake inhibitor class from Wyeth. It is a metabolite of venlafaxine (Effexor). Pristiq is also being targeted as the first non-hormonal based treatment for menopause^[1] .

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Approval status

It has completed Phase III trials and is waiting for approval by the U.S. Food and Drug Administration. Wyeth announced on 23 January 2007, that they received an "approvable" letter from the FDA for desvenlafaxine. Final approval to sell the drug is contingent on a number of things, including:

• a satisfactory FDA inspection of Wyeth's Guayama, Puerto Rico facility, where the drug is to be manufactured;
• several post-marketing commitments;
• clarity by Wyeth around the company's product education plan for physicians and patients;
• approval of desvenlafaxine's proprietary name, Pristiq.^[2]

Wyeth expects the drug to be approved for sales in early 2008. ^[3]

References

1. ^ (July 24,2007). "Wyeth Receives Approvable Letter From FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated With Menopause". Press release.
2. ^ (January 23, 2007). "Wyeth Receives Approvable Letter From FDA For Pristiq (Desvenlafaxine Succinate) For The Treatment Of Major Depressive Disorder". Press release. Retrieved on 2007-04-04.
3. ^ Wyeth (August 29, 2006). "Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate". Press release. Retrieved on 2007-04-04.