Columbia Laboratories has sold Striant® (testosterone buccal system) to Actient Pharmaceuticals for a combination of cash up front and royalties on annual sales above a certain threshold. The asset purchase agreement covers the U.S.
Columbia Laboratories also licensed to Actient certain intellectual property related to the underlying progressive hydration technology for use in the treatment of hypogonadism and other indications related to low testosterone levels in men.
The Urology Company markets Striant in Europe. The treatment was approved by the FDA in June 2003 for a deficiency or absence of endogenous testosterone associated with hypogonadism in men. The product uses Columbia Labs’ delivery technology to deliver testosterone across the buccal mucosa and into the bloodstream in a controlled, sustained manner.
The key ingredient in the company’s bioadhesive delivery system (BDS) is polycarbophil, a nonimmunogenic, hypoallergenic, bioadhesive polymer. Polycarbophil bonds to the cells of the body’s mucosal surfaces upon administration. In the case of Striant, it adheres to the cells of the oral mucosa.
Once in place, the BDS releases the active drug in a controlled and sustained manner until it is discharged upon normal cell turnover, Columbia Labs explains. This occurs up to every 24 hours for the oral mucosa, the firm adds.
Striant contains the active drug, polycarbophil, and a water-soluble carbomer. As the tablet absorbs water, the active drug is gradually released and absorbed across the mucosal surface to which the product is bonded. Meanwhile, the active ingredient is protected from the surrounding environment, preventing it from being metabolized or degraded by moisture, enzymes, or pH effects, according to Columbia Labs.