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6/23/2003

Novel Testosterone Product Approved for Marketing

Cheryl A. Thompson

A testosterone buccal system was approved Thursday for sale in the United States, according to Columbia Laboratories Inc., which claimed that its product, known as Striant, uses the first buccal delivery device approved by the Food and Drug Administration.

According to the company, the product is indicated as hormone replacement therapy in men with conditions, such as hypogonadism, associated with a deficiency or absence of endogenous testosterone. Each buccal system contains 30 mg of testosterone and is designed to slowly and constantly release the drug over the 12-hour dosing interval.

Labeling for the product is not yet available.

To use Striant, a patient places the product, which the company said resembles a small convex tablet, in the small depression where the gum meets the upper lip, above the incisors. Exposure to saliva softens the tablet, activates the adhesive that holds the tablet in place, and triggers the delivery system to release testosterone into the buccal mucosa. By absorption through the buccal mucosa, the drug reaches the superior vena cava without initial exposure to the liver's metabolic enzymes, the company said.

The product is contraindicated in men with known or suspected prostate cancer or known breast cancer and should not be used by women or anyone with a hypersensitivity to an ingredient in the delivery system.

According to the company, the most frequently reported adverse events from men who participated in the major U.S. study of the testosterone buccal system were gum or mouth irritation; a bitter taste; gum pain, tenderness, or edema; headache, and "taste perversion." Patients should be told to regularly inspect the area where they place the product and report any abnormality to their health care professional.

Columbia said it would start shipping Striant early in the third quarter of 2003.