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http://my.webmd.com/content/article/70/80945.htm
Date of approval: June 20, 2003
What is approved: Columbia Laboratories Inc. reports that the FDA has approved Striant (generic: testosterone buccal system), a system that slowly releases testosterone into the mucous membranes of the mouth. Striant is approved for men suffering from conditions stemming from testosterone deficiency, including hypogonadism. The Striant system offers an alternative to testosterone delivered by transdermal patches, topical gels, or injection.
Striant is a small, curved tablet -- about the size of an aspirin -- that is placed in the small depression where the gum meets the upper lip above the front teeth. It quickly sticks. Saliva softens the tablet into a gel, which stays in place for each 12-hour dosing period. Twice-a-day dosing is required for continuous testosterone delivery.
Testosterone delivered via the Striant delivery system doesn't go into the gut. Instead, it's absorbed by the mucous membrane and carried into a major blood vessel, the superior vena cava.
Striant is a controlled- and sustained- release tablet-like mucoadhesive buccal (gum surface) system containing 30mg of testosterone. Striant(TM) allows for the slow release and absorption of testosterone through gum and cheek surfaces that are in contact with the product. Dosing is twice-daily, with applications in the morning and in the evening, which maintains consistent and normal levels of testosterone.
When it will be available: Striant will be shipped to distributors in early third quarter, 2003.
Basis of approval: The manufacturer says it's regulatory team "completed the Phase III program and the required long-term safety studies."
Manufacturer: Columbia Laboratories Inc., Livingston, N.J.
Date of approval: June 20, 2003
What is approved: Columbia Laboratories Inc. reports that the FDA has approved Striant (generic: testosterone buccal system), a system that slowly releases testosterone into the mucous membranes of the mouth. Striant is approved for men suffering from conditions stemming from testosterone deficiency, including hypogonadism. The Striant system offers an alternative to testosterone delivered by transdermal patches, topical gels, or injection.
Striant is a small, curved tablet -- about the size of an aspirin -- that is placed in the small depression where the gum meets the upper lip above the front teeth. It quickly sticks. Saliva softens the tablet into a gel, which stays in place for each 12-hour dosing period. Twice-a-day dosing is required for continuous testosterone delivery.
Testosterone delivered via the Striant delivery system doesn't go into the gut. Instead, it's absorbed by the mucous membrane and carried into a major blood vessel, the superior vena cava.
Striant is a controlled- and sustained- release tablet-like mucoadhesive buccal (gum surface) system containing 30mg of testosterone. Striant(TM) allows for the slow release and absorption of testosterone through gum and cheek surfaces that are in contact with the product. Dosing is twice-daily, with applications in the morning and in the evening, which maintains consistent and normal levels of testosterone.
When it will be available: Striant will be shipped to distributors in early third quarter, 2003.
Basis of approval: The manufacturer says it's regulatory team "completed the Phase III program and the required long-term safety studies."
Manufacturer: Columbia Laboratories Inc., Livingston, N.J.
