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What's up all, I just wanted to introduce myself as a new member, I have been around the board for a while, but just now got around to creating an account/handle for myself...
Anyway, thought I would try to contribute some knowledge on my first post.... Some of you are probably aware of this products development and similar buccal type systems (I am fully in agreement inj is better, but this system is engineered for delivery, unlike sucking on some fina pellets), but here it is anyway...I always wanted a "constructive" alternative to chew since I quit, so now I guess there is one....
By the way, sides include gum or mouth irritation, bitter taste, gum pain, gum tenderness, headache, gum edema, and taste perversion. Patients are advised to regularly inspect the gum region where they apply Striant and report any abnormality to their health care professional.
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U.S. FDA APPROVES STRIANT™, A NEW TREATMENT FORM FOR MEN WITH A DEFICIENCY OR ABSENCE OF TESTOSTERONE, FROM COLUMBIA LABORATORIES
Striant offers a unique treatment option for the four to five million men in the United States who suffer from hypogonadism
LIVINGSTON, N.J.—June 20, 2003-- Columbia Laboratories, Inc. (AMEX: COB) today announced that the U.S. Food and Drug Administration (FDA) has approved Striant™ (testosterone buccal system) mucoadhesive (CIII), the first-ever transbuccal (gum surface) treatment for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, including hypogonadism. Striant offers a safe, effective and convenient option in testosterone replacement therapy for the nearly five million men suffering from a deficiency or absence of testosterone.
About Striant
Striant utilizes Columbia’s proprietary Bioadhesive Delivery System (BDS), including its patented progressive hydration buccal technology to deliver testosterone via the buccal cavity twice daily. The Striant approval provides the first commercial opportunity for this buccal delivery platform which may be used to deliver other previously approved and marketed drugs that cannot be ingested. The controlled- and sustained-release buccal testosterone product (which has the appearance of a small monoconvex tablet) 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 comfortably 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 (major blood vessel), bypassing the gastrointestinal system and liver. 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.
Anyway, thought I would try to contribute some knowledge on my first post.... Some of you are probably aware of this products development and similar buccal type systems (I am fully in agreement inj is better, but this system is engineered for delivery, unlike sucking on some fina pellets), but here it is anyway...I always wanted a "constructive" alternative to chew since I quit, so now I guess there is one....
By the way, sides include gum or mouth irritation, bitter taste, gum pain, gum tenderness, headache, gum edema, and taste perversion. Patients are advised to regularly inspect the gum region where they apply Striant and report any abnormality to their health care professional.
*****
U.S. FDA APPROVES STRIANT™, A NEW TREATMENT FORM FOR MEN WITH A DEFICIENCY OR ABSENCE OF TESTOSTERONE, FROM COLUMBIA LABORATORIES
Striant offers a unique treatment option for the four to five million men in the United States who suffer from hypogonadism
LIVINGSTON, N.J.—June 20, 2003-- Columbia Laboratories, Inc. (AMEX: COB) today announced that the U.S. Food and Drug Administration (FDA) has approved Striant™ (testosterone buccal system) mucoadhesive (CIII), the first-ever transbuccal (gum surface) treatment for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, including hypogonadism. Striant offers a safe, effective and convenient option in testosterone replacement therapy for the nearly five million men suffering from a deficiency or absence of testosterone.
About Striant
Striant utilizes Columbia’s proprietary Bioadhesive Delivery System (BDS), including its patented progressive hydration buccal technology to deliver testosterone via the buccal cavity twice daily. The Striant approval provides the first commercial opportunity for this buccal delivery platform which may be used to deliver other previously approved and marketed drugs that cannot be ingested. The controlled- and sustained-release buccal testosterone product (which has the appearance of a small monoconvex tablet) 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 comfortably 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 (major blood vessel), bypassing the gastrointestinal system and liver. 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.
