Columbia Laboratories, Inc. announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Striant SR 30 mg Mucoadhesive Buccal Tablets. Striant SR is the first transbuccal (gum surface) for testosterone replacement therapy in men with primary or secondary hypogonadism. Striant SR, marketed in the US as Striant, offers a safe, effective and convenient option in testosterone replacement therapy for men suffering from a deficiency or absence of testosterone.
The approval of Striant SR in the UK is the first step toward marketing Striant outside the US Ardana Bioscience, Ltd., the licensee in the UK and 17 additional countries within the EU, intends to commercialize Striant SR in second quarter, 2004. Columbia is initiating the mutual recognition process aimed at obtaining product approval from all member countries of the EU. Mipharm, SpA will be responsible for commercializing Striant SR in Italy. Columbia Laboratories will begin shipping Striant SR to Ardana in second quarter, 2004.
“We are pleased to have received our second regulatory approval for Striant and are looking forward to bringing an innovative new product to the UK and European markets for the millions of men suffering from hypogonadism,” stated Fred Wilkinson, Columbia’s CEO. “Striant’s novel delivery mechanism, which provides controlled, consistent and sustained therapeutic levels of testosterone, offers an attractive treatment option for many patients.”
About Hypogonadism Hypogonadism (low testosterone) can be caused by conditions associated with the testes, pituitary gland or hypothalamus gland, or by a genetic disorder. Signs and symptoms of hypogonadism can include decreased libido (sexual desire), erectile dysfunction (ED), fatigue, depression, reduced muscle mass, and osteoporosis. Testosterone replacement therapy helps to provide and maintain normal levels of testosterone. Until now, patients have been treated mainly with injectable formulations of testosterone, transdermal patches, topical gels and implants.
About Striant SR Striant SR 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 SR approval provides the first commercial opportunity outside the US 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 SR is able to produce circulating testosterone concentrations in hypogonadal males that approximate physiologic levels seen in healthy young men. Because Striant SR is available in a single strength, no dose titration is required.