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Claims for Patent: 9,254,278

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Claims for Patent: 9,254,278

Title:Methods of therapeutic monitoring of nitrogen scavenging drugs
Abstract: The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
Inventor(s): Scharschmidt; Bruce (San Francisco, CA), Mokhtarani; Masoud (Walnut Creek, CA)
Assignee: Horizon Therapeutics, Inc. (Deerfield, IL)
Application Number:14/816,674
Patent Claims: 1. A method of treating a subject with a urea cycle disorder, the method comprising: administering to the subject in need thereof glyceryl tri-[4-phenylbutyrate] in an amount sufficient to produce a fasting plasma ammonia level that is less than half the upper limit of normal for plasma ammonia level.

2. The method of claim 1, wherein the upper limit of normal for plasma ammonia level is 35 .mu.mol/L.

3. The method of claim 1, wherein the adjusted dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

4. A method for adjusting the dosage of glyceryl tri-[4-phenylbutyrate] in a subject being treated for a urea cycle disorder who has previously been administered an initial dosage of glyceryl tri-[4-phenylbutyrate] and who has a fasting plasma ammonia level less than the upper limit of normal for plasma ammonia level, the method comprising: (a) measuring a fasting plasma ammonia level for the subject; (b) comparing the fasting plasma ammonia level to the upper limit of normal for plasma ammonia level; and (c) administering an adjusted dosage of glyceryl tri-[4-phenylbutyrate], wherein the adjusted dosage is greater than the initial dosage if the fasting plasma ammonia level is greater than half the upper limit of normal for plasma ammonia level, and wherein the method further comprises restricting the subject's dietary protein intake.

5. The method of claim 4, further comprising repeating steps (a) to (c) until the subject exhibits a fasting plasma ammonia level at or below half the upper limit of normal for plasma ammonia level.

6. The method of claim 4, wherein the initial dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

7. The method of claim 4, wherein the adjusted dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

8. A method for adjusting the dosage of glyceryl tri-[4-phenylbutyrate] in a subject being treated for a urea cycle disorder who has previously been administered an initial dosage of glyceryl tri-[4-phenylbutyrate] and who has a fasting plasma ammonia level less than the upper limit of normal for plasma ammonia level, the method comprising: (a) measuring a fasting plasma ammonia level for the subject; (b) comparing the fasting plasma ammonia level to the upper limit of normal for plasma ammonia level; and (c) administering an adjusted dosage of glyceryl tri-[4-phenylbutyrate], wherein the adjusted dosage is greater than the initial dosage if the fasting plasma ammonia level is greater than half the upper limit of normal for plasma ammonia level, and wherein the method further comprises monitoring the subject's ammonia levels if the glyceryl tri-[4-phenylbutyrate] is not being adequately digested by the subject's pancreatic lipases.

9. The method of claim 8, further comprising repeating steps (a) to (c) until the subject exhibits a fasting plasma ammonia level at or below half the upper limit of normal for plasma ammonia level.

10. The method of claim 8, wherein the initial dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

11. The method of claim 8, wherein the adjusted dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

12. A method for adjusting the dosage of glyceryl tri-[4-phenylbutyrate] in a subject being treated for a urea cycle disorder who has previously been administered an initial dosage of sodium phenylbutyrate and who has a fasting plasma ammonia level less than the upper limit of normal for plasma ammonia level, the method comprising: (a) measuring a fasting plasma ammonia level for the subject; (b) comparing the fasting plasma ammonia level to the upper limit of normal for plasma ammonia level; (c) administering an initial dosage of glyceryl tri-[4-phenylbutyrate], wherein the initial dosage is determined by the amount of the initial dosage of sodium phenylbutyrate, and (d) administering an adjusted dosage of glyceryl tri-[4-phenylbutyrate], wherein the adjusted dosage is greater than the initial dosage of glyceryl tri-[4-phenylbutyrate] if the fasting plasma ammonia level is greater than half the upper limit of normal for plasma ammonia level.

13. The method of claim 12, further comprising repeating steps (a) to (c) until the subject exhibits a fasting plasma ammonia level at or below half the upper limit of normal for plasma ammonia level.

14. The method of claim 12, wherein the initial dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

15. The method of claim 12, wherein the adjusted dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.
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