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Claims for Patent: 8,404,215

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Claims for Patent: 8,404,215

Title:Methods of therapeutic monitoring of nitrogen scavenging
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: Hyperion Therapeutics, Inc. (South San Francisco, CA)
Application Number:13/417,137
Patent Claims: 1. A method for adjusting the dosage of a nitrogen scavenging drug in a subject who has previously been administered an initial dosage of the nitrogen scavenging drug, comprising: a) measuring a fasting blood ammonia level for the subject; b) comparing the fasting blood ammonia level to the upper limit of normal for blood ammonia level; and c) administering an adjusted dosage of the nitrogen scavenging drug, wherein the adjusted dosage is greater than the initial dosage if the fasting blood ammonia level is greater than half the upper limit of normal for blood ammonia level.

2. A method of administering a nitrogen scavenging drug to a subject having a nitrogen retention disorder comprising: a) measuring a fasting blood ammonia level for the subject; b) comparing the fasting blood ammonia level to the upper limit of normal for blood ammonia level; and administering the nitrogen scavenging drug to the subject if the fasting blood ammonia level is greater than half the upper limit of normal for blood ammonia level.

3. A method of treating a subject with a nitrogen retention disorder who has previously been administered an initial dosage of a nitrogen scavenging drug comprising: a) measuring a fasting blood ammonia level for the subject; b) comparing the fasting blood ammonia level to the upper limit of normal for blood ammonia level; and c) administering an adjusted dosage of the nitrogen scavenging drug that is greater than the initial dosage if the fasting blood ammonia level is greater than half the upper limit of normal for blood ammonia level.

4. The method of any of claims 1-3, wherein the nitrogen retention disorder is selected from the group consisting of a urea cycle disorder and hepatic encephalopathy.

5. The method of any of claims 1-3, wherein the nitrogen scavenging drug is a PAA prodrug.

6. The method of claim 5, wherein the PAA prodrug is selected from the group consisting of glyceryl tri-[4-phenylbutyrate] (HPN-100), phenylbutyric acid (PBA), sodium PBA (NaPBA), and a combination of two or more of HPN-100, PBA, and NaPBA.

7. The method of any of claims 1-3, wherein the nitrogen scavenging drug is sodium benzoate.

8. The method of claim 3 or 4, wherein administering an increased dosage of the nitrogen scavenging drug produces a normal average daily ammonia level in the subject.

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

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

11. The method of claim 5, further comprising: d) measuring urinary PAGN excretion; and e) determining an effective dosage of the PAA prodrug based on a mean conversion of PAA prodrug to urinary PAGN of 60-75%.
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