Am­neal touts re­sults from Phase III tri­al in Parkin­son's; No­vaRock part­ners on can­cer drug

Am­neal Phar­ma­ceu­ti­cals an­nounced pos­i­tive re­sults yes­ter­day from a piv­otal Phase III clin­i­cal tri­al that eval­u­at­ed IPX-203 in pa­tients with Parkin­son’s dis­ease who have mo­tor fluc­tu­a­tions.

The tri­al met its pri­ma­ry end­point, demon­strat­ing su­pe­ri­or “Good On” time — time with­out dysk­i­ne­sia — from base­line in hours per day at the end of the 13-week dou­ble-blind­ed treat­ment pe­ri­od with IPX-203, an ex­tend­ed-re­lease for­mu­la­tion of car­bidopa/lev­odopa. The drug da­ta was com­pared with im­me­di­ate-re­lease car­bidopa/lev­odopa.

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