Neurocrine posts full phase 3 Ingrezza data as PDUFA date, showdown with Teva in tardive dyskinesia near

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FDA is due to rule on Neurocrine's Ingrezza by April 11

Neurocrine Biosciences has published a journal paper about its phase 3 trial of tardive dyskinesia candidate Ingrezza. Publication of the paper comes weeks before a PDUFA date that could result in Neurocrine and Teva going head to head for the neurological disorder market in the years to come.

San Diego, CA-based Neurocrine published top-line results from the phase 3 trial of its vesicular monoamine transporter 2 inhibitor late in 2015. This week’s publication in The American Journal of Psychiatry fleshes out the dataset by providing additional details of the safety and efficacy of the candidate.

The trial linked 80 mg per day doses of Ingrezza to statistically-significant changes over placebo in scores on the Abnormal Involuntary Movement Scale (AIMS), resulting in it hitting its primary endpoint. Neurocrine also reported a significant difference in the proportion of patients in the drug and placebo arms whose AIMS score improved by 50% or more over the course of the study. The only adverse events to affect more than 5% of patients in the treatment arms were drowsiness and dry mouth. And the dropout rates due to adverse events were comparable across all the arms.

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Those data give Neurocrine confidence as its heads toward an April 11 PDUFA date. FDA cancelled a planned advisory committee review of the application earlier this year, an action Baird’s Brian Skorney interpreted as a positive for the company. Neurocrine is proceeding as if it is on the cusp of introducing the drug commercially. Last week, the company said it has started hiring the 140 field-based sales representatives it will task with making a success of the Ingrezza launch.

Hitting the ground running could enable Neurocrine to capture a chunk of the tardive dyskinesia market before competition starts hotting up. Teva has a rival drug working its way through the regulatory process. Like Ingrezza, Teva’s SD-809 is benefiting from priority review status. But with the PDUFA date for SD-809 set at August 30, Neurocrine is still positioned to have a slight head start and, in the eyes of some observers, stronger supporting data.

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