You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for Patent: 9,254,278


✉ Email this page to a colleague

« Back to Dashboard


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)
Filing Date:Aug 03, 2015
Application Number:14/816,674
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.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.