You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Claims for Patent: 11,344,551


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 11,344,551
Title:Methods of treating heavy menstrual bleeding
Abstract: The present invention relates to the method of treating heavy menstrual bleeding in a subject with or without uterine fibroids and in need of treatment by administering an effective amount of 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-ben- zyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino- )-butyric acid or a pharmaceutically acceptable salt thereof, in combination with estrogens and progestogens.
Inventor(s): Chwalisz; Kristof (Mundelein, IL), Williams; Laura A. (Gurnee, IL), Jain; Rita I. (Evanston, IL), North; Janine D. (Chicago, IL), Ng; Juki Wing-Keung (Highland Park, IL)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:16/776,230
Patent Claims: 1. A method of managing moderate to severe pain associated with endometriosis in a premenopausal adult human female patient, the method comprising: oral administration to the patient of 200 mg of 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-ben- zyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino- )-butyric acid, administered as a sodium salt ("elagolix"), and continuing said oral administration twice daily for a time period as needed to manage the moderate to severe pain associated with endometriosis, the time period not to exceed 6 months, wherein rifampin is not co-administered with elagolix during the time period; wherein the method reduces dysmenorrhea and non-menstrual pelvic pain in the subject without an increase in analgesic use while limiting bone mineral density loss from baseline in the patient caused by exposure to elagolix to less than 8%.

2. A method of managing dyspareunia associated with endometriosis in a premenopausal adult human female patient, the method comprising: oral administration to the patient of 200 mg of 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-ben- zyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino- )-butyric acid, administered as a sodium salt ("elagolix"), and continuing said oral administration twice daily for a time period as needed to manage the dyspareunia associated with endometriosis, the time period not to exceed 6 months, wherein rifampin is not co-administered with elagolix during the time period; wherein the method is effective to manage the dyspareunia associated with endometriosis while limiting bone mineral density loss from baseline in the patient caused by exposure to elagolix to less than 8%.

3. A method of managing moderate to severe pain associated with endometriosis in a premenopausal adult human female patient, the method comprising: oral administration of a first dose to the patient, said first dose comprising (i) 200 mg of 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-ben- zyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino- )-butyric acid, administered as a sodium salt ("elagolix"), (ii) 1.0 mg of estradiol, and (iii) 0.5 mg of norethindrone acetate; and oral administration of a second dose to the patient, said second dose comprising 200 mg of 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-ben- zyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino- )-butyric acid, administered as a sodium salt; wherein the first and second doses are administered in approximately the morning and evening of each day, respectively; wherein said administration of the first and second doses continues for a time period as needed to manage the moderate to severe pain associated with endometriosis, the time period not to exceed 48 months, wherein rifampin is not co-administered with elagolix during the time period; wherein the method reduces dysmenorrhea and non-menstrual pelvic pain in the subject without an increase in analgesic use while limiting bone mineral density loss from baseline in the patient caused by exposure to elagolix to less than 8%.

4. The method of claim 3, wherein the first dose comprises a first tablet containing elagolix and a second tablet containing estradiol and norethindrone acetate.

5. The method of claim 4, wherein the second dose comprises a tablet containing elagolix.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.