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Efficient Trial Design — FDA Approval of Valbenazine for Tardive Dyskinesia
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Efficient Trial Design — FDA Approval of Valbenazine for Tardive Dyskinesia
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Journal Article
Efficient Trial Design — FDA Approval of Valbenazine for Tardive Dyskinesia
2017
Overview
In the case of valbenazine, which was recently approved for tardive dyskinesia, a small company pursued thoughtful, efficient trial design and an unusual application of remote assessment in clinical trials, and the FDA took an engaged and flexible approach to review.
A well-executed development program that addresses both regulatory and clinical requirements is critical for making novel therapeutics available as quickly as possible to patients with unmet medical needs. In the case of valbenazine, which was recently approved by the U.S. Food and Drug Administration (FDA) for tardive dyskinesia — a debilitating, iatrogenic movement disorder that primarily affects patients with psychiatric illnesses — a small company pursued thoughtful, efficient trial design and an unusual application of remote assessment in clinical trials. The FDA took an engaged and flexible approach to review, which led to its first approval of a drug for . . .
Publisher
Massachusetts Medical Society
Subject
Antipsychotic Agents - adverse effects
/ Antipsychotic Agents - therapeutic use
/ Clinical Trials, Phase III as Topic
/ Humans
/ Patients
/ Synaptic Transmission - drug effects
/ Synaptic Transmission - physiology
/ Tardive Dyskinesia - chemically induced
/ Tardive Dyskinesia - drug therapy
/ Tetrabenazine - analogs & derivatives
/ Tetrabenazine - therapeutic use
/ United States Food and Drug Administration
/ Valine - analogs & derivatives
/ Vesicular Monoamine Transport Proteins - antagonists & inhibitors
