Method of treatment of symptoms of menopause
AssigneeKaNDy Therapeutics Limited
InventorsMike Trower, Monica Lazaro, Derek Bush, David Elder, Mary Kerr
Life of this patent
Estimating the term…
Abstract
The present invention generally relates to novel pharmaceutical formulations containing 2-[3,5-Bis(trifluoromethyl)phenyl]-N-{4-(4-fluoro-2-methylphenyl)-6-[(7S,9aS)-7-(hydroxymethyl)hexahydropyrazino[2,1-c][1,4]oxazin-8(1H)-yl]-3-pyridinyl}-N,2-dimethylpropanamide, methods of preparation thereof and their use in medical therapy.
Claims31
A method of treating insomnia associated with menopause, sleep disturbances associated with menopause, night time awakenings associated with menopause, or any combination thereof, comprising administering to a human in need thereof a pharmaceutically effective dose of 2-[3,5-Bis(trifluoromethyl)phenyl]-N-{4-(4-fluoro-2-methylphenyl)-6-[(7S,9aS)-7-(hydroxymethyl)hexahydropyrazino[2,1-c][1,4]oxazin-8(1H)-yl]-3-pyridinyl}-N,2-dimethylpropanamide (Compound A):
- or a pharmaceutically acceptable salt thereof;
- wherein Compound A or a pharmaceutically acceptable salt thereof is administered in an oral formulation so as to reach pharmacokinetic (PK) exposures with a Coefficient of Variation (CV %) of less than 50%.
Dependencies are inferred from the claim text.