LAUSR

The new contender seems to offer a lower risk of depression, somnolence and akathisia than the established competition. It still carries a black box warning, however, citing the risk of depression and suicidality. Teva, which gained the drug through the 2015 acquisition of Auspex, initially submitted deutetrabenazine for FDA approval in 2015. In 2016 it received a complete response letter citing the need for deeper analysis of the drug’s metabolites. Concert Pharmaceuticals, whose discovery focus is wholly on deuterated drugs, has also developed candidates to compete with nearly identical approved agents. Concert’s phase II candidate CTP-656, for example, is a deuterated version of Vertex Pharmaceuticals’ cystic fibrosis transmembrane conductance regulator (CFTR) potentiator ivacaftor for cystic fibrosis. CTP-656 seems to offer a longer half-life and a slower clearance profile than the approved small molecule. In March, Vertex acquired CTP-656 for US$160 million upfront and $90 million in potential milestones. Companies have started using deuterium in novel drugs as well. Vertex incorporated the isotope into its DNA-dependent protein FDA approves first deuterated drug