Duramed Initiates Clinical Study Involving 0.3 mg Dosage Strength of Cenestin(R)
* Important progress in Duramed's business plan to strengthen hormonal products portfolio * Lower dosage strength may provide same clinical beneficial effects as higher dosage strength
CINCINNATI, Nov 16, 2000 /PRNewswire via COMTEX/ -- Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD chart, msgs) announced today that it has initiated a clinical study to compare the effects of slow-release 0.3 mg dosage strength Cenestin(R) (synthetic conjugated estrogens, A) Tablets versus placebo in the treatment of vaginal atrophy. Vaginal atrophy occurs in up to 40 percent of postmenopausal women. Symptoms include vaginal inflammation, discomfort, and itching associated with dryness and loss of elasticity.
"Relief from vaginal atrophy is important for women because, unlike hot flashes, which are vasomotor symptoms that can eventually subside, vaginal atrophy persists as long as there is estrogen depletion," said Jeffrey T. Arington, Duramed President and Chief Operating Officer.
In this multi-center, double-blind, randomized, parallel, and placebo- controlled clinical study, sixty healthy postmenopausal women will be treated with Cenestin 0.3 mg or placebo daily for 16 weeks. The results of the trial are expected to be filed with the FDA in the third quarter of 2001.
Arington continued, "This study is significant because it may show that, when compared to higher dosage strengths, conjugated estrogens in lower dosage strengths can have the same beneficial effects and improve patient tolerance. For that reason, low dose estrogens are generally well received among women because they may make it easier for women to remain on the therapy. This study is also an important step towards our filing a 0.3 mg dosage strength of Cenestin, which provides a full complement to our solid oral dose conjugated estrogens product offering."
About Duramed Pharmaceuticals, Inc.
Duramed Pharmaceuticals develops, manufactures and markets prescription drug products. The company's business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women's health and the hormone replacement therapy market. On March 24, 1999, the FDA approved the company's first branded product, Cenestin(R) (synthetic conjugated estrogens, A) Tablets, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
Duramed's containment manufacturing facility for the production of hormones distinguishes the company from most competitors. The facility incorporates enclosed product flow and state-of-the-art environmental controls to ensure purity, stability, and tablet uniformity for Cenestin and other hormone products. While Duramed's primary focus will be solid oral dose hormones, the company's other areas of concentration -- controlled release technology and oncology -- continue to represent attractive market opportunities.
On October 6, 1999, Duramed entered into an alliance with Solvay Pharmaceuticals, Inc. to jointly promote three of the companies' hormone products to obstetricians and gynecologists across the United States: Duramed Pharmaceuticals' Cenestin and Solvay Pharmaceuticals' Estratest(R)(2) and Prometrium(R)(3).
The company's stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at www.duramed.com and www.cenestin.com .
(1) Premarin is a trademark of Wyeth-Ayerst Laboratories, Inc.
(2) Estratest is a trademark of Solvay Pharmaceuticals.
(3) Prometrium is a trademark of Solvay Pharmaceuticals.
Like all estrogen drug products, CENESTIN(R) Tablets should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women with an intact uterus. The most common adverse events reported in clinical experience with CENESTIN included headache, insomnia, asthenia, nervousness, paresthesia, and depression. For additional information on CENESTIN, please see full prescribing information.
The Securities and Exchange Commission (SEC) encourages companies to disclose forward-looking information so that investors can better understand a company's future prospects and make informed investment decisions. Due to changing market conditions, product competition, the nature of product development and regulatory approval processes, the achievement of forward- looking statements contained in this press release are subject to risks and uncertainties. For further details and a discussion of these risks and uncertainties, see Duramed's SEC filings, including its annual report on Form 1O-K.
Source: Duramed Pharmaceuticals, Inc.
Contact:
Investor Relations, Duramed Pharmaceuticals, Inc., 513-731-
9900; or Media, Ellen Knight or Carrie Krysanick of Dan Pinger Public
Relations, Inc., 513-564-0700
URL: duramed.com
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