Merck Sharp + Dohme Corp.

Merck + Co., Inc.

Craig B Ikeda

W Mark Eickhoff

Wei Xu

Leonardo Resende Allain

Mary Ann Johnson

Chad D Brown

Melanie Marota

Lisa Lupton

Paresh B Patel

Hanmi Xi

Francis J Flanagan, Jr

Rebecca Nofsinger

Benjamin Cohen

Aaron S Cote

Hsien-Hsin Tung

Robert A Reed

Justin Moser

Erik A Dienemann

Vincent R Capodanno

Kimberly Gallagher

Pavol Rajniak

Cindy Starbuck

Qingxi Wang

Brian Sell

Jeannie Chow Wong

Thomas Allen Miller

Tzyy-Show H Chen

The present disclosure provides methods for the acute treatment of migraine with or without aura, comprising the administration of ubrogepant. In particular, the present disclosure provides methods for the acute treatment of migraine in patients having hepatic impairment; in patients with renal impairment; and in patients concurrently taking CYP3A4 modulators or BCRP and/or P-gp only inhibitors.

Treatment of migraine

Pharmaceutical formulations for the treatment of migraine

The present invention is directed to compositions comprising an extrudate or solid solution of a compound, or a salt thereof, of Formula I (API): wherein 'R' is independently —H or —F, in a water-soluble polymer matrix which further comprises a disintegration system allowing a tablet made therefrom to rapidly disintegrate in the environment in which the API is to be released.

Tablet formulation for CGRP active compounds

The present invention is directed to compositions comprising an extrudate or solid solution of a compound, or a salt thereof, of Formula I (API): Formula I, wherein 'R' is independently H or &#x2014;F, in a water-soluble polymer matrix which further comprises a disintegration system allowing a tablet made therefrom to rapidly disintegrate in the environment in which the API is to be released. 

The present invention provides a pharmaceutical composition or crystalline composition with a specific dissolution profile, which comprises suberoylanilide hydroxamic acid or a pharmaceutically acceptable salt or hydrate thereof as an active ingredient. The present invention provides a process of producing said crystalline composition or pharmaceutical composition. The present invention also provides compositions with a specific particle size distribution.

Formulations of suberoylanilide hydroxamic acid and methods for producing same

Formulations of suberoylanilide hydroxamic acid and methods for producing the same

Tablet

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Harleysville, PA, United States of America

Craig B Ikeda