Source: Circulation  |  Posted 5 years ago

Soltamox represents new therapeutic option for patients with breast cancer who desire an alternative to swallowing pills

PRINCETON, NJ -- August 17, 2006 -- Cytogen Corporation announced that Soltamox(TM) (tamoxifen citrate, oral solution 10mg/5mL), the first liquid form of the hormonal breast cancer therapy tamoxifen, is currently being introduced in the United States and is available in U.S. pharmacies nationwide.

Soltamox received U.S. Food and Drug Administration marketing approval in October 2005 and is indicated for the treatment of metastatic breast cancer and to reduce the incidence of breast cancer in women who are at high risk for the disease. The Gail Model Risk Assessment Tools will be available from Cytogen to aid in accessing risk.

"Cytogen is extremely pleased to be bringing this important alternative treatment option to patients across the country who are affected by breast cancer or who are at risk for developing the disease," said Michael D. Becker, president and chief executive officer of Cytogen.

Difficulty swallowing, a condition called dysphagia, is a common complication of cancer therapy, resulting in particular from treatment involving radiation or chemotherapy. Cancer patients with dysphagia experience problems swallowing pills due to mouth and throat sores, inflammation or dry mouth. To address this problem, many patients resort to cutting or crushing drugs administered in pill form. This can lead to risks including altered dosing efficacy or side effects associated with improper dosing. In addition, patients with dysphagia may be less likely to comply with prescribed regimens because swallowing is difficult or painful.

As with other versions of tamoxifen, the Soltamox product label also includes a black box warning with information on the potential risk of adverse events. The boxed warning states that: "Serious and life threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with ductal carcinoma in situ) include uterine malignancies, stroke and pulmonary embolism." Full prescribing information for Soltamox is available on Cytogen's Web site at http://www.cytogen.com.

Cytogen has exclusive marketing rights for Soltamox in the United States under a distribution agreement. Soltamox is a trademark and the product is also licensed in the United Kingdom, Ireland and Germany.

About Breast Cancer
Breast cancer is the most common non-skin cancer in women and the second leading cause of death in women after lung cancer. An estimated 212,920 women in the United States will be diagnosed with breast cancer in 2006, according to the American Cancer Society. Currently, more than two million women in the United States have been treated for breast cancer. The chance of a woman having invasive breast cancer during her life is about 1 in 8. Estrogen is known to promote the growth of approximately two-thirds of breast cancers that contain estrogen or progesterone receptors. Breast cancer treatment often involves agents designed to block the effect of estrogen or lower estrogen levels. Tamoxifen, the most commonly used anti-estrogen drug, has been shown to reduce the risk of cancer recurrence and improve overall survival in all age groups.

About Soltamox
Soltamox is a sugar-free, clear colorless liquid, with licorice and aniseed odor and taste. It is supplied in a 150mL bottle. Each 5mL dose contains 15.2 mg tamoxifen citrate, which is equivalent to 10 mg tamoxifen. The recommended daily dose is 20-40 mg. Dosages greater than 20 mg per day should be divided into morning and evening doses. A 20 mg dose of Soltamox is administered as 10mL of the oral solution.

Use of Soltamox in a risk reduction setting (women at high risk for cancer and women with ductal carcinoma in situ) has been shown to cause cancer of the uterus, as well as stroke and blood clots. Some of these strokes, blood clots, and uterine malignancies were fatal. The benefits of Soltamox outweigh its risks in a population of women already diagnosed with breast cancer. Soltamox should not be used in women who require concomitant use of coumarin-type anticoagulant, or in women with a history of deep vein thrombosis or pulmonary embolus. Women who are pregnant or plan to become pregnant should not take Soltamox. Cataracts and resultant cataract surgery can also result more frequently as a result of using Soltamox. The most frequently reported adverse reactions with Soltamox were hot flashes and vaginal discharge.

SOURCE: Cytogen Corporation