Claims for Patent: 12,246,054

Summary for Patent: 12,246,054

Title:	Method of treating diseases
Abstract:	Methods of treating acromegaly in a subject are described herein. Exemplary methods include orally administering to the subject at least once daily at least one dosage form comprising octreotide, wherein the octreotide in each dosage form is 20 mg, and wherein the administering occurs at least 1 hour before a meal or at least 2 hours after a meal.
Inventor(s):	Roni Mamluk, Sam L. Teichman
Assignee:	Amryt Endo Inc
Application Number:	US18/599,125
Patent Claims:	1. A method of treating acromegaly in a subject in whom prior treatment with a somatostatin analog has been shown to be effective and tolerated, the method comprising orally administering to the subject at least one dosage form comprising octreotide, wherein the oral administration provides a mean peak plasma octreotide concentration of about 3.5+/−0.5 ng/ml, wherein the total amount of octreotide orally administered per day is from 40 mg to 80 mg, and wherein the oral administration provides improved control of acromegaly symptoms compared to treatment with an injectable somatostatin analog. 2. The method of claim 1, wherein the dosage form comprises an oily suspension which is formulated into a capsule. 3. The method of claim 2, wherein the capsule is enterically coated. 4. The method of claim 1, wherein the amount of octreotide in each dosage form is 20 mg. 5. The method of claim 1, wherein the at least one dosage form is orally administered twice a day. 6. The method of claim 1, wherein at least one dosage form is orally administered in the morning and at least one dosage form is orally administered in the evening. 7. The method of claim 6, wherein the total amount of octreotide orally administered per day is 40 mg. 8. The method of claim 6, wherein the total amount of octreotide orally administered per day is 60 mg. 9. The method of claim 6, wherein the total amount of octreotide orally administered per day is 80 mg. 10. The method of claim 1, wherein the method is for long-term maintenance therapy in acromegaly patients. 11. The method of claim 7, wherein if insulin-like growth factor 1 (IGF-1) level of the subject is normal and the subject's clinical signs and symptoms are controlled, or biochemical and symptomatic response level of the subject is maintained by the oral administration of 40 mg daily of octreotide, then the total amount of octreotide orally administered per day is continued at 40 mg. 12. The method of claim 7, wherein if IGF-1 level of the subject is not normal and the subject's clinical signs and symptoms are not controlled, or biochemical and symptomatic response level of the subject is not maintained by the oral administration of 40 mg daily of octreotide, then the total amount of octreotide orally administered per day is increased to 60 mg. 13. The method of claim 12, wherein if IGF-1 level of the subject is normal and the subject's clinical signs and symptoms are controlled, or biochemical and symptomatic response level of the subject is maintained by the oral administration of 60 mg daily of octreotide, then the total amount of octreotide orally administered per day is continued at 60 mg daily. 14. The method of claim 12, wherein if IGF-1 level of the subject is not normal and the subject's clinical signs and symptoms are not controlled, or biochemical and symptomatic response level of the subject is not maintained by the oral administration of 60 mg daily of octreotide, then the total amount of octreotide orally administered per day is increased to 80 mg. 15. The method of claim 1, wherein the oral administration provides a mean area under the curve of octreotide of about 15+/−4 h·ng/mL. 16. The method of claim 1, wherein the oral administration controls the growth hormone (GH) level or the IGF-1 level or acromegaly symptoms of the subject. 17. The method of claim 16, wherein the oral administration provides an in vivo concentration of IGF-1 equal to or less than 1.3 times the upper limit of the age-adjusted normal range (ULN).