Al­ler­gan, Richter prep for FDA OK with pos­i­tive PhI­II for cariprazine in bipo­lar de­pres­sion

Al­ler­gan $AGN and its part­ner Gedeon Richter came out this morn­ing with some af­firm­ing Phase III da­ta of its drug cariprazine, set­ting the duo on track for an add-on FDA OK that could mean big mon­ey for the part­ners.

The drug, al­ready ap­proved un­der the brand name Vray­lar for schiz­o­phre­nia and man­ic episodes, was test­ed in pa­tients with de­pres­sive episodes as­so­ci­at­ed with bipo­lar 1 dis­or­der. Dur­ing the tri­al, called RGH-MD-53, 493 pa­tients were giv­en ei­ther a 1.5 mg dose of cariprazine, a 3 mg dose, or place­bo. For the pa­tients on the small­er dose, sec­ondary and pri­ma­ry end­points were met, show­ing a sig­nif­i­cant­ly greater im­prove­ment than place­bo for the change from base­line to week 6 on both the pri­ma­ry ef­fi­ca­cy pa­ra­me­ter, the Mont­gomery-As­berg De­pres­sion Rat­ing Scale (p=0.0417), and the key sec­ondary pa­ra­me­ter, Clin­i­cal Glob­al Im­pres­sion Scale-Sever­i­ty (p=0.0417).

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