Wyeth reassures analysts on Pristiq By LINDA A. JOHNSON, AP Business Writer

Wyeth reassures analysts on Pristiq By LINDA A. JOHNSON, AP Business Writer
1 hour, 9 minutes ago



TRENTON, N.J. - Federal regulators' demand for further testing of a nonhormonal drug for menopause symptoms should not delay approval of the same drug as a depression treatment, executives at drugmaker Wyeth said late Tuesday.

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In a conference call to address concerns triggered by the Food and Drug Administration's decision to require an entire new study of the drug Pristiq, officials at Wyeth said they will work closely with the FDA to speed the drug's approval as the first nonhormonal treatment for menopause symptoms.

On July 16 the FDA said it wants more data on Pristiq's effects on the heart and liver because a very small number of women in studies of the drug for menopause symptoms — mood swings, hot flashes and trouble sleeping — had serious heart or liver complications. The FDA requested Wyeth conduct a randomized, placebo-controlled clinical trial of one year or longer, a huge blow to Wyeth.

"We believe Pristiq is a safe, effective and much-needed nonhormonal therapy" for menopause, Greg Norden, Wyeth's chief financial officer, told analysts during a conference call Tuesday.

Executives at Madison, N.J.-based Wyeth also said FDA officials have reassured them that the additional safety data required to get approval as a menopause symptom treatment will not hold up approval of Pristiq as a depression treatment.

"We continue to believe it will receive approval in the first quarter of 2008" for depression, Norden said.

The study the FDA requested means the company likely won't be able to reapply for approval of the drug as a menopause drug for about 18 months, and the agency will then have about six months to review the new data and reach a decision.

The company had been counting on the drug's approval last week — or at least nothing more than a short delay — to help it rebound from a huge drop in sales of its Premarin and Prempro after the federal Women's Health Initiative in 2002 linked Prempro to higher rates of heart attacks, strokes, breast cancer and other problems. Subsequent research has found the risks were generally limited to women taking hormones in their 60s and 70s.

The two drugs were once the company's top sellers.

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On the Net: http://www.wyeth.com