Striant is sanctioned in the U.S. for a deficiency or absence of endogenous testosterone associated with hypogonadism in men.
Columbia Laboratories inked a license deal with Invaron Pharmaceuticals for Striant® (testosterone buccal system). Invaron will seek regulatory approval for and will market Striant in Canada. Columbia will receive a royalty on annual net sales, assuming Invaron receives Health Canada regulatory approval. Invaron’s main purview is the acquisition of niche drugs and medical devices registered in other countries but not in Canada.
Striant was approved by the FDA in June 2003 for a deficiency or absence of endogenous testosterone associated with hypogonadism in men. It is marketed by Actient Pharmaceuticals in the U.S. and The Urology Company in Europe.
The product was developed on Columbia’s bioadhesive drug delivery system (BDS). The key ingredient in the BDS technology is polycarbophil, a nonimmunogenic, hypo-allergenic, bioadhesive polymer. Polycarbophil bonds to the cells of the body’s mucosal surfaces upon administration.
In Striant, which is a buccal product, polycarbophil adheres to the cells of the oral mucosa. Besides Striant, Columbia has developed and sold six products on the BDS platform for the U.S. market, including Crinone®. Crinone is a vaginally-administered progesterone gel that is designed to bond to the vaginal epithelial cells.
Once in place, the BDS releases the active drug in a controlled and sustained manner until it is discharged upon normal cell turnover, Columbia reports. This occurs every three to five days for the vaginal epithelium and up to every 24 hours for the oral mucosa.
Crinone was approved by the FDA in May 1997 for progesterone supplementation or replacement as part of an assisted reproductive technology (ART) treatment for infertile women with a progesterone deficiency. Watson markets the product in the U.S. and Merck Serono markets it outside the U.S.