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Endocrine News
FDA approves testosterone buccal treatment
July 2003
ROCKVILLE, Md. — Men who require testosterone replacement therapy are now able to receive it through a testosterone buccal system (Striant, Columbia Laboratories) that was recently approved by the FDA. The therapy is approved for men with conditions associated with a deficiency or absence of endogenous testosterone, including hypogonadism.
About 86% of patients achieved a testosterone concentration within the normal range after 12 weeks of therapy in the trial that formed the basis for the FDA approval.
The new product uses a proprietary bioadhesive delivery system that delivers testosterone via the buccal cavity twice a day. The drug resembles a small monoconvex tablet and acts by rapidly adhering to the buccal mucosa: the small, natural depression in the mouth where the gum meets the upper lip above the incisor teeth.
As it is exposed to saliva, the product softens into a gel-like form, which remains in place over each 12-hour dosing period. The product delivers testosterone through the buccal mucosa, where it is absorbed into the bloodstream and delivered directly into the superior vena cava, bypassing the gastrointestinal system and liver. It produces circulating testosterone concentrations in hypogonadal men that approximate physiologic levels seen in healthy young men. Because it is available in a single strength, no dose titration is required.
Approval data
The clinical data supporting the FDA approval came from a 12-week multicenter, open-label, single-arm trial that evaluated the efficacy, safety and tolerability of the system in 98 hypogonadal men. Of the 82 patients who completed the trial, 86.6% had an average testosterone concentration within the physiologic range at the end of 12 weeks.
The buccal delivery was well-accepted by patients in these clinical studies. In the U.S. trial 98 patients, the most frequent adverse events that occurred with an incidence of 1% or greater were: gum or mouth irritation, bitter taste, gum pain, gum tenderness, headache, gum edema and taste perversion.
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FDA approves testosterone buccal treatment
July 2003
ROCKVILLE, Md. — Men who require testosterone replacement therapy are now able to receive it through a testosterone buccal system (Striant, Columbia Laboratories) that was recently approved by the FDA. The therapy is approved for men with conditions associated with a deficiency or absence of endogenous testosterone, including hypogonadism.
About 86% of patients achieved a testosterone concentration within the normal range after 12 weeks of therapy in the trial that formed the basis for the FDA approval.
The new product uses a proprietary bioadhesive delivery system that delivers testosterone via the buccal cavity twice a day. The drug resembles a small monoconvex tablet and acts by rapidly adhering to the buccal mucosa: the small, natural depression in the mouth where the gum meets the upper lip above the incisor teeth.
As it is exposed to saliva, the product softens into a gel-like form, which remains in place over each 12-hour dosing period. The product delivers testosterone through the buccal mucosa, where it is absorbed into the bloodstream and delivered directly into the superior vena cava, bypassing the gastrointestinal system and liver. It produces circulating testosterone concentrations in hypogonadal men that approximate physiologic levels seen in healthy young men. Because it is available in a single strength, no dose titration is required.
Approval data
The clinical data supporting the FDA approval came from a 12-week multicenter, open-label, single-arm trial that evaluated the efficacy, safety and tolerability of the system in 98 hypogonadal men. Of the 82 patients who completed the trial, 86.6% had an average testosterone concentration within the physiologic range at the end of 12 weeks.
The buccal delivery was well-accepted by patients in these clinical studies. In the U.S. trial 98 patients, the most frequent adverse events that occurred with an incidence of 1% or greater were: gum or mouth irritation, bitter taste, gum pain, gum tenderness, headache, gum edema and taste perversion.
[Endocrine Today Homepage]
[Current Issue] [Back Issues]
[Endocrine News] [Practice Management]
[Meetings & Courses] [Industry Link]
[Professional Marketplace]
__________________
