FDA Announces New Drug Approval for Menopause

Enjuvia: Synthetic, Plant-Derived Estrogen Helps Hot Flashes

From the WebMD Archives

May 11, 2004 -- The FDA has approved Enjuvia for treatment of moderate to severe symptoms related to menopause, the drug's manufacturer reports.

Enjuvia is a plant-derived estrogen product. It was developed by Endeavor Pharmaceuticals, which in December 2003 sold the product to Barr Pharmaceuticals Inc. Barr also makes another plant-derived estrogen product, Cenestin, through its wholly owned subsidiary Duramed Pharmaceuticals. Cenestin received FDA approval in 1999.

"We believe that Enjuvia, which is a patented synthetic conjugated estrogens product, will offer a new generation of hormonal products to American women electing to use hormone therapy," Barr CEO Bruce L. Downey said in a news release.

Clinical studies show that Enjuvia can reduce the frequency and severity of hot flashes in women going through menopause. Doses as low as 0.3 milligram were reported to be effective. However, the current FDA approval applies only to Enjuvia at doses of 0.625 milligrams and 1.25 milligrams. An application for FDA approval of lower-dose Enjuvia tablets is pending.

Because some studies link estrogen therapy to increased risk of endometrial cancer in postmenopausal women with uteruses, doctors usually prescribed it in combination with progestin hormones. Because of other potential risks of estrogen therapy, current recommendations advise using the treatment at as low a dose as possible and for as short a time as possible.

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SOURCES: News release, Barr Pharmaceuticals, May 11, 2004. News release, Endeavor Pharmaceuticals Inc., Oct. 3, 2002. FDA web site.
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