Duramed Phamaceuticals targets women’s health

New Apri offered as OC value brand’

Family planners now have three alternatives when prescribing a desogestrel and ethinyl estradiol oral contraceptive (OC): Ortho-Cept from Ortho-McNeil Pharmaceutical of Raritan, NJ; Desogen from Organon of West Orange, NJ; and the newest addition, Apri from Duramed Pharmaceuticals of Cincinnati. The new OC is being marketed as a "value brand" and should be available at a savings of approximately 30% below the retail cost of comparable pills, according to Ellen Knight, Duramed spokeswoman.

Apri is the first substitutable product equivalent to Ortho-Cept and Desogen, both of which offer 30 mcg of ethinyl estradiol and 150 mcg of desogestrel. Apri received Food and Drug Adminis tration (FDA) approval in August 1999 and began shipment in October, according to Knight.

The OC represents Duramed’s first birth control pill, but providers should be prepared to see similar products from the company in the future, she notes. Duramed has nine other OCs in its product development program.

Apri also marks the first product launch from Duramed’s product-development alliance with Gedeon Richter Ltd., a Hungarian pharmaceutical company and one of the major suppliers of bulk active raw materials for OC products worldwide.

A longtime manufacturer of generic pharmaceuticals, Duramed has gained FDA approval for the following products in the last two years:

Medroxyprogesterone acetate tablets, therapeutically interchangeable with Provera tablets manufactured by Pharmacia & Upjohn of Bridgewater, NJ, for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance. Manufacturing of the product had begun as of Dec. 2, and Duramed said distribution is expected to commence within 60 days.

Estropipate tablets, comparable to Ogen tablets, also manufactured by Pharmacia & Upjohn. Estropipate may be used in estrogen replacement therapy (ERT) to treat moderate to severe vasomotor symptoms of menopause and help prevent osteoporosis. Duramed’s products are available in 0.75 mg, 1.5 mg, and 3 mg strengths.

Estradiol tablets, comparable to Estrace tablets manufactured by Bristol-Myers Squibb of Princeton, NJ. Duramed’s products are available in 0.5 mg, 1 mg, and 2 mg strengths and are indicated in ERT. In addition, the FDA granted Duramed the rights to market a 1.5 mg estradiol tablet, a strength that is unavailable from any other source.

Duramed’s largest foray into women’s health care began in 1994, when it began to pursue a generic equivalent to Premarin, a conjugated estrogens drug product from Wyeth-Ayerst Laboratories of Philadelphia. The FDA ruled that a synthetic version of Premarin could not be approved because the active ingredients of the drug had not been adequately defined. Duramed moved to develop a separate product, Cenestin, which gained regulatory acceptance in March 1999.

Cenestin is made of nine synthetic estrogen components. Those synthetic components are chemically derived from a compound obtained from plant material. The product is available in two dosage strengths: 0.625 mg and 0.9 mg.

As Contraceptive Technology Update went to press, Duramed anticipated receiving regulatory approval for the 1.25 mg tablet strength of Cen -es tin by the close of 1999, and consent for the 0.3 mg tablet strength in mid-2000.

Short-term use approved

The FDA has determined that Cenestin is safe for short-term use in the treatment of such vasomotor symptoms as hot flashes and sweating. It has not been approved for long-term use, such as the prevention of osteoporosis; however, the company is conducting research to gain a long-term indication, confirms Knight.

One important element of the clinical trials — the bone marker study — is complete, Knight says. Although results have not been published, preliminary results are favorable and show a reduction in bone markers, indicating a bone preservation effect. The company anticipates beginning the full osteoporosis clinical study this year to confirm the beneficial results indicated by the bone marker study.

Duramed recently filed an Investigational New Drug application with the FDA to study the effects of medroxyprogesterone acetate administered cyclically with Cenestin. Duramed anticipates initiating the related Phase III clinical trials in the coming months and filing a New Drug Application upon completion of those trials.

While Cenestin and Premarin are conjugated estrogens drug products, Cenestin is a synthetic product chemically derived from a compound obtained from plant material, and Premarin is made from the urine of pregnant mares.

Cenestin has the advantage of being derived from plant sources, and therefore offers an alternative to Premarin for individuals who have ethical or emotional problems with use of equine urine sources, says James Simon, MD, clinical professor of OB/GYN at George Washington University in Washington, DC. Simon, who practices in a private OB/GYN practice in Washing ton, DC, also runs the Women’s Health Research Center in Laurel, MD, an independent research center. He developed the protocol for Cenestin’s approval for vasomotor symptoms.

"It is another alternative, one that is chemically and pharmacokinetically similar to Premarin, and so people have yet another alternative," Simon remarks of Cenestin. "The more alternatives, the better, since this class of compounds seems to be underutilized based on the number of women who are menopausal and the number of women who are candidates for ERT."

Duramed Pharmaceuticals, 7155 E. Kemper Road, Cincinnati, OH 45249. Telephone: (513) 731-9900. Fax: (513) 731-5270. Web: www. duramed.com. For more on Cenestin, go to www.cenestin.com.