June 12, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Pfizer Inc. ’s flunked Phase III trial for depression drug Pristiq in pediatric patients is unlikely to hurt the company’s bottom line, analysts said Friday, and may have different outcomes in the next three Phase III studies scheduled for the drug.
Pfizer announced late Thursday that it had failed to meet primary endpoints in a double-blind study that followed 340 randomize patients ages seven to 17. All of those children suffered from major depressive disorder and the hope was that Pristiq, or desvenlafaxine succinate sustained-release formulation, would do better than a placebo when treating the disease—which it did not.
Now Pfizer must regroup and hope that its next three studies, which it has agreed to do as part of a post-marketing commitment it made with the U.S. Food and Drug Administration (FDA) under the Pediatric Research Equity Act, will do better.Pfizer bought Pristiq from Wyeth in 2009.
Analysts at Zacks said the failure was unlikely to dent Pfizer’s bottom line much, given that Pristiq raked in $737 million in 2014, up 6 percent year-over-year.
“We note that Pristiq is already approved in the U.S. for the treatment of adult patients suffering from MDD,” they wrote in a note to investors. “In addition, the drug is approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause in Thailand, Mexico, the Philippines and Ecuador.”
Enormous competition in the field might eventually hurt Pfizer’s depression pipeline, however, they said. “We note that the market for depression drugs is already crowded given the presence of companies like Eli Lilly and Company , among others,” they said.
Pfizer stressed Thursday that so Pristiq appeared to be largely safe, if not effective in this particular trial.
“There were no new safety signals identified,” it said in a statement. “Adverse events occurring after the start of treatment in the desvenlafaxine succinate sustained-release formulation group were generally consistent with those observed in both the Phase 2a pediatric MDD safety studies and the studies of desvenlafaxine succinate sustained-release formulation-treated adults with MDD.”
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