Xanodyne obtained 505(b)(2) approval for tranexamic acid for use in treating heavy menstrual bleeding (menorrhagia). The RLD is Cyklokapron(R) which is used to treat hemophilia and to reduce the need for replacement therapy during and following tooth extraction. The RLD received orphan approval in 1986. Initially, both tablet and injectable dosage forms were approved but the tablet was discontinued in 2003.
Xanodyne’s product is a modified release tablet. The 505(b)(2) NDA was submitted January 30, 2009. It was granted Priority Review status which specifies a 6-month review cycle. However, it received FDA approval in 9.5 months.
Tranexaminc acid has been used for many years for menorrhagia, with numerous controlled trials. Xanodyne capitalized on this body of knowledge and also made the formulation change to improve market position.