Wyeth Pristiq Anti-Depressant Has Mixed Trial Data

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Wyeth Pristiq Anti-Depressant Has Mixed Trial Data

(December 12, 2007) NEW YORK, (Reuters) - Wyeth said on Wednesday that a low-dose 50-milligram form of its experimental Pristiq depression drug was effective in two late-stage trials and far better tolerated than a 100-milligram version that failed to win U.S. approval in January.

The 100-milligram version of Wyeth's most important experimental medicine proved ineffective in one of the new Phase 3 studies, tarnishing overall results of the two trials.

"We find the data underwhelming and continue to question the drug's commercial potential," Morgan Stanley analyst Jami Rubin said in a research report, noting she had reservations about her own $1 billion-a-year sales projection for the medicine.

Wyeth on Wednesday said the 50-milligram dose of Pristiq showed statistically significant effectiveness against depression among adults in both new trials, one conducted in the United States and one overseas. It submitted the results to the U.S. Food and Drug Administration in August.

Company spokeswoman Gwen Fisher said the percentage of patients on the 50-milligram formulation who dropped out of the trials because of side effects was similar to those receiving placebo, indicating the low-dosage pill was well tolerated.

Wyeth hopes to hear back from the FDA on its marketing application for Pristiq in the first quarter, Fisher said.

Fisher said Wyeth had asked the FDA to approve Pristiq at a 50-milligram recommended starting dose. Higher dosages could be deemed appropriate for some patients, based upon data from trials, she said.

In studies of the 100-milligram dose of Pristiq conducted more than a year ago, a high percentage of patients complained of nausea and stopped taking the medicine -- creating doubts that many doctors would prescribe it or patients take it even if it were approved.

The FDA in January refused to approve the product, in part because of long-standing quality-control lapses at a Wyeth plant in Puerto Rico where Pristiq was to be manufactured.

As the plant problems were tackled and eventually resolved, Wyeth forged ahead with the pair of new studies, results of which were to be released on Wednesday at a medical meeting in Florida.

Wyeth had hoped the 50-milligram form of Pristiq would cause less nausea than the 100-milligram form but still prove effective.

Compared with placebo, the 100-milligram dose was effective only in the international study, Wyeth said, in contrast with efficacy seen in both low-dose groups of the same studies.

More than twice as many patients taking the 100-milligram pills dropped out of the trials due to side effects, including nausea, than those taking placebos.

Pristiq is a derivative of Wyeth's widely used Effexor depression drug and the company has been hoping that it would be approved long before Effexor loses its U.S. patent protection in 2010 and faces generic competition.

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Some analysts have described Pristiq as a "me, too" drug, with few distinguishing characteristics. Indeed, Wyeth has not cited any major advantages the drug might have over Effexor.

Although Wyeth has also tested Pristiq as a treatment for hot flashes in post-menopausal women, the FDA last summer said it could not approve the drug for that condition until Wyeth resolved concerns about potentially serious heart and liver problems.

By Ransdell Pierson
Source: Reuters

Last updated: 12/07

Wyeth Pristiq Anti-Depressant Has Mixed Trial Data

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