Claims for Patent: 11,510,963

Summary for Patent: 11,510,963

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 Teichman
Assignee:	Amryt Endo Inc
Application Number:	US17/879,557
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 at least 1 hour before a meal, at least 2 hours after a meal or 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, wherein the dosage form comprises: a composition comprising a suspension which is an admixture of a hydrophobic medium and a solid form, wherein the solid form comprises: a therapeutically effective amount of octreotide and a medium chain fatty acid salt, wherein the composition comprises 12% to 18% by weight of the medium chain fatty acid salt. 2. The method of claim 1, wherein the medium chain fatty acid salt is sodium octanoate. 3. The method of claim 1, wherein the solid form further comprises a matrix forming polymer. 4. The method of claim 3, wherein the composition comprises 5% to 15% by weight of the matrix forming polymer. 5. The method of claim 3, wherein the matrix forming polymer is polyvinylpyrrolidone (PVP). 6. The method of claim 4, wherein the matrix forming polymer is PVP and the medium chain fatty acid salt is sodium octanoate. 7. The method of claim 1, wherein the composition comprises 12% to 18% by weight of sodium octanoate, 5% to 15% by weight of polyvinylpyrrolidone, 20% to 80% by weight of glyceryl tricaprylate, and 3% to 10% by weight of a surfactant. 8. The method of claim 7, wherein the surfactant is glyceryl monocaprylate or polyoxyethylene sorbitan monooleate, or a combination thereof. 9. The method of claim 1, wherein the composition comprises about 65% by weight of glyceryl tricaprylate, about 4% by weight of glyceryl monocaprylate, about 2% by weight of polyoxyethylene sorbitan monooleate, about 15% by weight of sodium octanoate, about 10% by weight of polyvinylpyrrolidone having a molecular weight of about 3000 and about 1% to about 5.5% by weight of octreotide. 10. The method of claim 1, wherein the dosage form is an enterically coated capsule. 11. The method of claim 1, wherein the octreotide is octreotide acetate. 12. The method of claim 1, wherein the subject is dosed in the morning and in the evening, comprising a first and second administration. 13. The method of claim 12, wherein the first administration includes one or two dosage forms and the second administration includes one or two dosage forms. 14. The method of claim 12, wherein the first administration includes one dosage form and the second administration includes one dosage form. 15. The method of claim 12, wherein the first administration includes two dosage forms and the second administration includes one dosage form. 16. The method of claim 12, wherein the first administration includes two dosage forms and the second administration includes two dosage forms. 17. The method of claim 1, wherein one dosage form is administered twice a day. 18. The method of claim 1, wherein two dosage forms are administered twice a day. 19. The method of claim 1, wherein one dosage form is administered once a day and two dosage forms are administered once a day. 20. The method of claim 1, wherein the total amount of octreotide administered per day to the subject is 40 mg. 21. The method of claim 20, 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. 22. The method of claim 21, 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. 23. The method of claim 22, 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. 24. The method of claim 23, 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. 25. 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.