U.S. Food and Drug Administration (FDA) has approved Striant (testosterone buccal system) - the 1st buccal (gum surface) treatment for testosterone low level therapy including hypogonadism.

Approval occurred within the FDA's ten-month review time frame as defined under the Prescription Drug User Fee Act.

Testosterone Buccal System offers a safe, effective and convenient alternative in testosterone low level therapy. At present about 5 million men suffering from a low level of testosterone.

Testosterone low level are determined in men of all ages, with a significant number of patients having symptoms over age 60. In most patients in the clinical tests, Testosterone Buccal System quickly achieved and maintained a stabilise, consistent level of testosterone within 10 to 12 hours of starting therapy.

Hypogonadism (low testosterone level) can be caused by conditions associated with the testicles, hypophysis, hypothalamus gland or by a genetic defect. Symptoms of hypogonadism can include reduced libido (sexual desire), erectile dysfunction (ED), fatigue, depressive disorder, reduced muscle mass and osteoporosis. Testosterone low level therapy assists to supply and keep normal levels of testosterone. As yet, patients have been treated with skin patches, topical gels or injectable preparations of testosterone.

Testosterone Buccal System (Striant) applies Columbia's branded Bioadhesive Delivery System (BDS), including its patented progressive hydration buccal technology to deliver testosterone thru the buccal cavity twice daily. The Striant approval supplies the first commercial opportunity for this buccal delivery platform which may be used to deliver other previously approved and marketed drugs that can't be absorbed. The Testosterone Buccal System (which has the appearance of a small monoconvex tab) acts by quickly sticking to to the buccal mucous membrane (the small depression in the lip where the gum meets the upper lip above the incisor teeth) where it's absorbed into the bloodstream and delivered instantly into the superior vena cava (major blood vessel), bypassing the digestive system and liver. As it's exposed to saliva the product softens into a gel form, which stays comfortably in place over each 12-hour drugging period. Striant is able to produce circulating testosterone concentrations in hypogonadal males that approximate physiologic levels seen in healthy young men. Because Striant is available in a single strength, no dose titration is required.

The clinical data supporting the FDA approval of Testosterone Buccal System were generated from a 12-week U.S. multicenter, open-label, single arm trial that evaluated the efficacy, safety and tolerability of Testosterone Buccal System in 98 hypogonadal men. Of the 82 patients who completed the trial, 86.6 percent had an average testosterone concentration within the physiologic (normal) range at the end of 12 weeks. Testosterone Buccal System was also evaluated in a seven-day, multicenter, open-label European parallel trial with 29 patients receiving Testosterone Buccal System. At the conclusion of this shorter trial, 96.6 percent of Testosterone Buccal System patients had an average testosterone concentration within the physiologic (normal) range. The novel buccal delivery was well-accepted by patients in these clinical studies.

In the U.S. pivotal trial involving 98 patients, the most frequent adverse events that occurred with an incidence of one percent or greater were: gum or mouth irritation, bitter taste, gum pain, gum tenderness, headache, gum edema and taste perversion. The majority of the gum-related adverse events were transient and resolved within 1 to 14 days. Patients should be advised to regularly inspect the gum region where they apply Testosterone Buccal System and report any abnormality to their health care professional.

Testosterone Buccal System is not indicated for use in women and should not be used in patients with known hypersensitivity to any of its ingredients. Androgens are contraindicated in men with carcinoma of the breast, or known or suspected carcinoma of the prostate. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.