FDA approval was subject to several post-marketing commitments, including conducting and submitting data from a new long-term maintenance (relapse prevention) study, a sexual dysfunction study, pediatric studies and a study exploring lower doses. The agency also requested an additional non-clinical toxicity study. Wyeth expects to begin shipping Pristiq to wholesalers beginning in the second quarter of 2008.
Philip Ninan, vice president of Wyeth Medical Affairs, Neuroscience, said: “Pristiq is approved at a once-daily 50-mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose. We are encouraged by the tolerability profile seen in clinical studies.”