Therapeutic Regimens
This invention relates to clinically useful therapeutic regimens comprising the administration of (R)-6-(2-(ethyl(4-(2-(ethylamino)ethyl)benzyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol.
1 . A unit dosage form comprising 10 mg of the compound of formula I as its dihydrochloride salt
2 . The unit dosage form according to claim 1 , further comprising one or more pharmaceutically acceptable excipients.
3 . The unit dosage form according to claim 2 , wherein the unit dosage form is a tablet or capsule suitable for oral administration.
4 . The unit dosage form according to claim 3 , wherein following oral administration the unit dosage form, is more than 50% dissolved in the stomach prior to being released into the small intestines.
5 . The unit dosage form according to claim 4 , wherein the unit dosage form is not coated with an acid resistant coating.
6 . A method of treating vasomotor disturbances in a peri-menopausal or postmenopausal woman in need thereof comprising administering to the woman the unit dosage form of claim 1 .
7 - 8 . (canceled)
9 . The method according to claim 6 , wherein the unit dosage form is more than 50% dissolved in the stomach prior to being released into the small intestines.
10 . The method according to claim 9 , wherein the unit dosage form is not coated with an acid resistant coating.
11 . A method of treating vasomotor disturbances in a peri-menopausal or postmenopausal woman in need thereof comprising administering to the woman a compound of formula I or a salt thereof
wherein the administration results in a steady state C max of from 0.40 ng/mL to 1.43 ng/mL.
12 . The method of claim 11 , wherein a steady state trough level of the compound of formula I ranging from 0.11 ng/mL to 0.79 ng/mL or ranging from 0.12 ng/mL to 0.86 ng/mL is achieved.
13 . The method of claim 11 , wherein the compound of formula I is in the form of a dihydrochloride salt.
14 . (canceled)
15 . The method of claim 13 , wherein the compound is orally administered once daily in a unit dosage form.
16 . (canceled)
17 . The method of claim 15 , wherein the unit dosage form is a capsule or tablet and is more than 50% dissolved in the stomach prior to being released into the small intestines.
18 . The method according to claim 17 , wherein the unit dosage form is not coated with an acid resistant coating.
19 . A method of treating vasomotor disturbances in a peri-menopausal or postmenopausal woman in need thereof comprising administering to the woman a compound of formula I or a salt thereof
wherein the administration results in a steady state C max of from 0.22 ng/mL to 1.61 ng/mL
20 . The method of claim 19 , wherein the compound of formula 1 is in its dihydrochloride salt form.
21 . The method of claim 19 , wherein a steady state trough level of the compound of formula I ranging from 0.11 ng/mL to 0.79 ng/mL or ranging from 0.12 ng/mL to 0.86 ng/mL is achieved.
22 . The method of claim 19 , wherein the compound of formula I is in the form of a dihydrochloride salt.
23 . (canceled)
24 . The method of claim 22 , wherein the compound is orally administered once daily in a unit dosage form.
25 . (canceled)
26 . The method of claim 24 , wherein the unit dosage form is a capsule or tablet and is more than 50% dissolved in the stomach prior to being released into the small intestines.
27 . The method according to claim 26 , wherein the unit dosage form is not coated with an acid resistant coating.