Mitchell V. Mathis
Center for Drug Evaluation and Research
13 Papers
75 Citations
Mitchell V. Mathis is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Clinical trial & Medicine. The author has an hindex of 7, co-authored 13 publications.
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Papers
Review of Maintenance Trials for Major Depressive Disorder: A 25-year Perspective From the US Food and Drug Administration
Silvana Borges,Yeh-Fong Chen,Thomas Laughren,Robert Temple,Hiren D. Patel,Paul A. David,Mitchell V. Mathis,Ellis F. Unger,Peiling Yang,Ni A. Khin +9 more
TL;DR: Antidepressant maintenance trials have a high rate of success, indicating a benefit of continuing drug treatment after initial response to an antidepressant, and this benefit appears to result mainly from a decreased rate of recurrent depression rather than from an effect of drug withdrawal in the placebo groups.
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Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.
Thomas Laughren,Jogarao V. S. Gobburu,Robert Temple,Ellis F. Unger,Atul Bhattaram,Phillip V. Dinh,Linda Fossom,H. M. James Hung,Violetta Klimek,Jee Eun Lee,Robert L. Levin,Cheri Y. Lindberg,Mitchell V. Mathis,Barry N. Rosloff,Sue-Jane Wang,Yaning Wang,Peiling Yang,Bei Yu,Huixia Zhang,Li Zhang,Issam Zineh +20 more
TL;DR: Vilazodone is a new treatment for MDD, but it is unknown whether it has any advantages compared to other drugs in the antidepressant class.
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CYP2D6 Genotype Information to Guide Pimozide Treatment in Adult and Pediatric Patients: Basis for the US Food and Drug Administration’s New Dosing Recommendations
Hobart Rogers,Atul Bhattaram,Issam Zineh,Jogarao V. S. Gobburu,Mitchell V. Mathis,Thomas Laughren,Michael Pacanowski +6 more
TL;DR: Given the risk of increased pimozide concentrations and longer time to steady state in CYP2D6 poor metabolizers, the FDA has revised the pimozides label to provide clinicians with clearer dosing, titration, and genotype testing recommendations.
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The US Food and Drug Administration's Perspective on the New Antidepressant Vortioxetine
Jing Zhang,Mitchell V. Mathis,Jenn W. Sellers,George Kordzakhia,Andre J. Jackson,Antonia Dow,Peiling Yang,Linda Fossom,Hao Zhu,Hiren D. Patel,Ellis F. Unger,Robert Temple +11 more
TL;DR: The issues that were important to the FDA's approval decision are emphasized, particularly the difference in the effective dose in domestic and foreign studies, and several new labeling features are noted, specifically, description of time course of treatment response and detailed sexual dysfunction evaluation.
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Efficient Trial Design — FDA Approval of Valbenazine for Tardive Dyskinesia
Michael C. Davis,Brian J. Miller,Brian J. Miller,Jasmeet K. Kalsi,Thomas Birkner,Mitchell V. Mathis +5 more
TL;DR: 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.
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