Claims for Patent: 12,097,187

Summary for Patent: 12,097,187

Title:	Opioid receptor modulator dosage formulations
Abstract:	Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6 -dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy -benzoic acid, and processes for the preparation and administration of these formulations.
Inventor(s):	Tim Costello, Leonard Scott Dove, J. Michael Davenport, Gail McIntyre, Paul Covington, David Andrae
Assignee:	Allergan Holdings ULC
Application Number:	US18/324,449
Patent Claims:	1. A method of reducing the frequency of abdominal pain and diarrhea in an adult human patient suffering from irritable bowel syndrome with diarrhea, comprising orally administering to the adult human patient in need thereof 75 mg of 5-({[(2S)-2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[(1S)-1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid twice daily with food. 2. The method of claim 1, wherein the patient achieves improvement in daily worst abdominal pain (WAP) score by at least 20% compared to baseline. 3. The method of claim 1, wherein the patient achieves improvement in daily worst abdominal pain (WAP) score by at least 30% compared to baseline. 4. The method of claim 1, wherein the patient achieves improvement in stool consistency as measured by reduction in Bristol Stool Scale (BSS) to between 2 and 5. 5. The method of claim 1, wherein the patient achieves improvement in stool consistency as measured by reduction in Bristol Stool Scale (BSS) to less than 5. 6. The method of claim 1, wherein the patient achieves improvement in: a) daily worst abdominal pain (WAP) score by at least 30% compared to baseline; and b) stool consistency as measured by reduction in Bristol Stool Scale (BSS) to less than 5.