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Treatment for Moderate-to-Severe Hot Flashes Cleared by FDA

MAPLE GROVE, Minn., June 5 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. announced today that it received approval from the United States Food and Drug Administration (FDA) for the marketing of Divigel (estradiol gel) 0.1 percent. Divigel(R) offers the lowest approved dose of estradiol available for the treatment of moderate to severe hot flashes associated with menopause.

"Divigel provides a valuable choice for women that are suffering from hot flashes," said Dr. Richard Hedrick, Jr., key investigator, Hawthorne OB/GYN Associates. "Women experienced a low incidence of side effects and a decrease in the frequency and severity of hot flashes was observed as early as two weeks with Divigel in clinical trials."

Guidelines from the North American Menopause Society (NAMS) indicate that estrogen hormone therapy should be used at the lowest effective dose for the shortest amount of time.

"The availability of Divigel supports the NAMS guidelines given that this product provides the lowest approved dose of estradiol therapy on the market to treat hot flashes," said Dr. Hedrick. "Hot flashes are one of the most common symptoms of menopause, so safe, low-dose therapy is critical to help women cope with them."

The estrogen in Divigel is derived from plant sources and is identical to the primary estrogen produced by a woman's ovaries before menopause. Certain older oral estrogen therapies contain conjugated estrogens derived from the urine of pregnant mares. Divigel(R) is a quick-drying gel that is odorless when dry, and is available in convenient, individual-use packets. One packet of gel is applied daily to an area that measures approximately 5 x 7 inches on the thigh where it absorbs directly into the bloodstream without having to pass through the liver. Divigel(R) also offers dosing flexibility with three different strengths (0.25 mg estradiol/day, 0.5 mg estradiol/day and 1.0 mg estradiol/day) to individualize treatment for each woman and the smallest application area compared to all other available gel or lotion estrogen products.

"We are pleased that the FDA recognizes the value that this convenient, low-dose therapy brings to women that are experiencing uncomfortable hot flashes associated with menopause," said Mark Evenstad, President, Upsher-Smith Laboratories, Inc. "Our organization has worked closely with the FDA on the approval of this therapy, and we look forward to making the product commercially available in July 2007."

Source: Upsher-Smith Laboratories

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