Claims for Patent: 11,338,011

Summary for Patent: 11,338,011

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):	Mamluk; Roni (Mazkeret Batya, IL), Teichman; Sam L. (Oakland, CA)
Assignee:	Amryt Endo, Inc. (Needham, MA)
Application Number:	17/094,238
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 administering occurs on an empty stomach, to thereby treat the subject, wherein the total amount of octreotide administered per day to the subject is 40 mg, 60 mg, or 80 mg. 2. The method of claim 1, wherein the dosage form comprises a composition which comprises an oily suspension which is formulated into a capsule. 3. The method of claim 2, wherein the oily suspension comprises an admixture of a hydrophobic medium and a solid form, wherein the solid form comprises the octreotide and at least one salt of a medium chain fatty acid. 4. The method of claim 2, wherein the oily suspension comprises an admixture of a hydrophobic medium and a solid form, wherein the solid form comprises the octreotide, at least one salt of a medium chain fatty acid, and polyvinylpyrrolidone (PVP), wherein the at least one salt of a medium chain fatty acid is present in the dosage form at an amount of at least 12% by weight and wherein the PVP is present in the dosage form at an amount of 3% or more by weight. 5. The method of claim 2, wherein the composition comprises octreotide, about 12-21% of sodium octanoate by weight, about 5-15% of polyvinylpyrrolidone by weight, about 20-80% of glyceryl tricaprylate by weight, and about 3-10% of surfactant by weight. 6. The method of claim 2, wherein the capsule is enterically coated. 7. The method of claim 1, wherein the octreotide is octreotide acetate. 8. The method of claim 1, wherein the subject is dosed in the morning and in the evening, comprising a first and second administration. 9. The method of claim 8, wherein the first administration includes one or two dosage forms and the second administration includes one or two dosage forms. 10. The method of claim 8, wherein the first administration includes one dosage form and the second administration includes one dosage form. 11. The method of claim 8, wherein the first administration includes two dosage forms and the second administration includes one dosage form. 12. The method of claim 8, wherein the first administration includes two dosage forms and the second administration includes two dosage forms. 13. The method of claim 1, wherein one dosage form is administered twice a day. 14. The method of claim 1, wherein two dosage forms are administered twice a day. 15. The method of claim 1, wherein one dosage form is administered once a day and two dosage forms are administered once a day. 16. The method of claim 1, wherein the total amount of octreotide administered per day to the subject is 40 mg. 17. The method of claim 16, wherein if IGF-1 is normal and clinical symptoms are controlled or biochemical and symptomatic response is maintained, then administration of octreotide is continued at a total daily dose of 40 mg. 18. The method of claim 17, wherein the total daily dose of octreotide is 40 mg and wherein if IGF-1 is not normal and clinical symptoms are not controlled or biochemical and symptomatic response is not maintained, then administration of octreotide is increased to a total daily dose of 60 mg. 19. The method of claim 18, wherein the total daily dose of octreotide is 60 mg and wherein if IGF-1 is normal and clinical symptoms are controlled or biochemical and symptomatic response is maintained, then administration of octreotide is continued at the total daily dose of 60 mg. 20. The method of claim 19, wherein the total daily dose of octreotide is 60 mg and wherein if IGF-1 is not normal and clinical symptoms are not controlled or biochemical and symptomatic response is not maintained, then administration of octreotide is increased to a total daily dose of 80 mg. 21. The method of claim 1, wherein, upon administration of the dosage form, the GH level or the IGF-1 level or acromegaly symptoms are controlled.