ARDANA RECEIVES UK REGULATORY APPROVAL FOR
STRIANT TM SR TESTOSTERONE REPLACEMENT THERAPY FOR MEN WITH HYPOGONADISM
Ardana Bioscience, the specialty pharmaceutical company dedicated
to better reproductive health, has gained UK regulatory approval
to market Striant TM SR, a testosterone replacement therapy for
men with primary or secondary hypogonadism.
Striant TM SR is presented as 30 mg mucoadhesive buccal tablets
and it is the first transbuccal (gum surface) product for testosterone
replacement therapy in men with primary or secondary hypogonadism
(ie those suffering from a deficiency or absence of testosterone).
Striant TM SR represents a new addition to the available armamentarium
of effective therapeutic options in the treatment of male hypogonadism.
Ardana acquired key European rights to Striant TM SR from the
US pharmaceutical company Columbia Laboratories Inc (NASDAQ CBRX)
in October 2002. Ardana has rights to market Striant TM SR in
18 European countries and Columbia is initiating the mutual recognition
process aimed at obtaining product approval from all member countries
of the EU. Mipharm, S.p.A. will be responsible for commercialising
Striant TM SR in Italy.
Dr Maureen Lindsay, Ardana Chief Operating Officer said: This
is a significant milestone for Ardana and it enables us to deliver
our stated strategic aim of launching our first product during
the first half of 2004. Ardana is a specialty pharmaceutical company
operating in a number of niche markets and employing commercial,
marketing and sales teams with broad international experience
in reproductive health. Through our relevant experience, well
trained sales force and clear market focus we aim to provide key
specialists with comprehensive support.
Male Hypogonadism (which is characterised by testosterone levels
below the normal range) 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 is designed to provide and maintain normal
levels of testosterone. Alternative therapies include injectable
formulations of testosterone, oral preparations, transdermal patches,
topical gels and subcutaneous implants.
Striant TM SR utilises Columbia’s proprietary Bioadhesive
Delivery System (BDS) to deliver testosterone via the buccal cavity
twice daily. The tablet adheres to 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
and delivers consistent levels of mean serum total testosterone
that approximate the physiologic levels seen in healthy young
men (10.4-36.4 nmol/L ;
3.0-10.5ng/mL).
back to top
|
