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Claims for Patent: 9,326,966

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Claims for Patent: 9,326,966

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. (Lake Forest, IL)
Application Number:14/958,259
Patent Claims: 1. A method of treating a subject with 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] that 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, wherein the upper limit of normal for plasma ammonia level is in the range of 26-64 .mu.mol/L.

2. The method of claim 1, wherein the upper limit of normal for plasma ammonia level is in the range of 32-38 .mu.mol/L.

3. The method of claim 2, wherein the upper limit of normal for plasma ammonia level is in the range of 34-36 .mu.mol/L.

4. The method of claim 1, 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.

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

6. A method of treating a pediatric subject with 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 pediatric 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] that 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.

7. The method of claim 6, further comprising repeating steps (a) to (c) until the pediatric subject exhibits a fasting plasma ammonia level at or below half the upper limit of normal for plasma ammonia level.

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

9. A method of treating an adult subject with 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 adult 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] that 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.

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

11. The method of claim 9, wherein the adjusted dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

12. A method of treating a patient having a urea cycle disorder comprising: (a) administering an initial effective dosage of glyceryl tri-[4-phenylbutyrate] (HPN-100) to the patient, wherein the initial effective dosage is calculated based on body surface area of the patient; (b) measuring the patient's urinary PAGN and/or fasting plasma ammonia level to determine whether to change the dosage of the glyceryl tri-[4-phenylbutyrate] (HPN-100); and (c) administering a subsequent effective dosage of glyceryl tri-[4-phenylbutyrate] (HPN-100) to the patient that is either the same as the initial effective dosage or is an increased dosage, wherein said increased dosage, if any, is calculated based on the patient's urinary PAGN and/or fasting plasma ammonia level.

13. The method of claim 12, further comprising repeating steps (b) 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 effective dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

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