Acrux, Vivus deal

Vivus terminated a 2004 deal with Acrux's FemPharm Pty Ltd. subsidiary that granted Vivus U.S. rights to develop and commercialize Luramist testosterone metered-dose transdermal spray (MDTS). Vivus said the decision was based on the significant long-term safety requirements for obtaining approval of testosterone products in women. In 2008, Vivus received an SPA from FDA for a Phase III program of Luramist to treat hypoactive sexual desire disorder, which included the requirement for a Phase III safety study in about 5,200 women aged 50 years or older with at least one cardiovascular risk factor. ...