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First Oral Liquid Formulation of Tamoxifen Launched

First Oral Liquid Formulation of Tamoxifen Launched

Cytogen Corporation recently announced that Soltamox (tamoxifen citrate, oral solution 10 mg/5 mL), the first liquid form of the hormonal breast cancer therapy tamoxifen, is currently being introduced in the United States and is available in US pharmacies nationwide. The product received US 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. "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.

Addresses Dysphagia

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 website at www.cytogen.com/.

Soltamox is a sugar-free, clear colorless liquid, with licorice and aniseed odor and taste. It is supplied in a 150 mL bottle. Each 5-mL dose contains 15.2 mg tamoxifen citrate, which is equivalent to 10 mg tamoxifen.

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