Pfizer's Pristiq antidepressant comes up short for kids

When the FDA approved Wyeth's antidepressant Pristiq in 2008, the nod came with a number of provisions to do postmarketing studies, including one in pediatric patients. Seven years later, Pfizer ($PFE), which bought Wyeth in a 2009 megamerger, has fulfilled that obligation to disappointing results. The drug failed to hit its endpoint.

The company reported on Thursday that in a Phase III study of major depressive disorder in children 7 to 17 Pristiq ER was no more effective than a placebo. Pfizer said it was the first of four Phase III pediatric trials being conducted under its commitment to the FDA. Pfizer completed another FDA-required follow-up study last fall that found Pristiq was not more likely to cause sexual dysfunction than a placebo.

The postmarketing studies are not the only obligations for Pristiq that Wyeth left for Pfizer to fulfill. It also got saddled with some legal issues. Pfizer paid $67.5 million in 2012 to settle a class-action lawsuit with Wyeth shareholders who claimed the company had not warned them about the safety concerns of the drug. The suit was filed after a 2007 announcement that FDA wouldn't approve the company's Pristiq to treat hot flashes without more information about its safety, news that trimmed its market value by $7.6 billion in a one-day free fall.

The drug is not a blockbuster, but it has done well for Pfizer over the years. Sales were actually up 11% in 2013, before succumbing to competition in the U.S. last year and falling 6% to $723 million. Sales were down 6% in the last quarter to $161 million. Pfizer last year had to recall nearly 221,000 bottles of 50-mg Pristiq Extended Release tablets after a single 100-mg pill was found in a 50-mg bottle.

- here's the announcement

Suggested Articles

Which rollouts might suffer most? Those that treat chronic diseases, require doctors to administer them or face current competition, analysts say.

Novartis and Incyte will put their blockbuster JAK inhibitor into phase 3 clinical trials as a possible treatment for COVID-19, the drugmakers said.

The Cannes Lions canceled its advertising creativity conference for 2020 after media reports that many large ad agencies planned to opt out.