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Claims for Patent: 9,095,559

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Claims for Patent: 9,095,559

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:13/775,000
Patent Claims: 1. 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.

2. 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.

3. A method of administering glyceryl tri-[4-phenylbutyrate] to a subject having a urea cycle disorder, the method comprising: (a) measuring a first fasting plasma ammonia level for the subject; (b) comparing the first fasting plasma ammonia level to the upper limit of normal for plasma ammonia level; and (c) administering an initial dosage of glyceryl tri-[4-phenylbutyrate] to the subject if the fasting plasma ammonia level is greater than half the upper limit of normal for plasma ammonia level and less than the upper limit of normal for plasma ammonia level.

4. The method of claim 1 or 2, wherein administering the adjusted dosage of glyceryl tri[4-phenylbutyrate] produces a normal average daily ammonia level in the subject.

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 3, further comprising: (d) measuring a second fasting plasma ammonia level for the subject; (e) comparing the second fasting plasma ammonia level to the upper limit of normal for plasma ammonia level; and (f) administering an adjusted dosage of glyceryl tri-[4-phenylbutyrate] that is greater than the initial dosage if the second fasting plasma ammonia level is greater than half the upper limit of normal for plasma ammonia level and less than the upper limit of normal for plasma ammonia level.

7. The method of any of claims 1-3, wherein the upper limit of normal for plasma ammonia level is 35 .mu.mol/L.

8. The method of any of claims 1-3, wherein the upper limit of normal is specific to the laboratory in which the fasting plasma ammonia level is measured.

9. The method of any of claims 1-3, further comprising the step of determining an upper limit of normal for plasma ammonia level for the subject prior to step (b).

10. The method of claim 1 or 2, wherein the adjusted dosage is calculated by: (i) measuring urinary phenylacetyl glutamine (P AGN) output; and (ii) calculating an effective adjusted dosage of glyceryl tri-[4-phenylbutyrate] based on the urinary P AGN output, wherein the effective adjusted dosage is calculated based on a mean conversion of glyceryl tri-[4-phenylbutyrate] to urinary PAGN of 60 to 75%.

11. The method of claim 3, wherein the initial dosage is calculated by: (i) determining a target urinary phenylacetyl glutamine (P AGN) output; and (ii) calculating an effective initial dosage of glyceryl tri-[4-phenylbutyrate] based on a mean conversion of glyceryl tri-[4-phenylbutyrate] to urinary PAGN of 60 to 75%.

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

13. The method of claim 2, wherein the adjusted dosage of glyceryl tri-[4-phenylbutyrate] is administered orally.

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

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