US009095559B2
`
`(12) United States Patent
`Scharschmidt et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 9,095,559 B2
`Aug. 4, 2015
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`METHODS OF THERAPEUTC
`MONITORING OF NITROGEN SCAVENGING
`DRUGS
`
`Applicant: Horizon Therapeutics, Inc., Palo Alto,
`CA (US)
`Inventors: Bruce Scharschmidt, San Francisco,
`CA (US); Masoud Mokhtarani, Walnut
`Creek, CA (US)
`Assignee: HORIZON THERAPEUTICS, INC.,
`Deerfield, IL (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 230 days.
`Appl. No.: 13/775,000
`
`Notice:
`
`Filed:
`
`Feb. 22, 2013
`
`Prior Publication Data
`US 2013/0210914 A1
`Aug. 15, 2013
`
`Related U.S. Application Data
`Division of application No. 13/417,137, filed on Mar.
`9, 2012, now Pat. No. 8,404,215.
`Provisional application No. 61/542,100, filed on Sep.
`30, 2011, provisional application No. 61/564,668,
`filed on Nov. 29, 2011.
`
`Int. C.
`A6 IK 49/00
`A6IPI3/00
`A6 IK3I/26
`GOIN3L/22
`U.S. C.
`CPC ............ A6 IK3I/216 (2013.01); G0IN 31/221
`(2013.01); Y10T 436/175383 (2015.01)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`
`
`(58) Field of Classification Search
`CPC ............... A61K 31/216; G01N 31/221; Y10T
`436/175383
`USPC ........... 424/9.2: 514/432, 433, 544, 570, 533;
`436/4, 113
`See application file for complete search history.
`
`(56)
`
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`
`FOREIGN PATENT DOCUMENTS
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`WO94,22494
`WO
`6, 2005
`WO WO 2005/0536O7 A1
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`
`(Continued)
`
`Primary Examiner — Savitha Rao
`(57)
`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 tech
`nique to adjust the dosage of a nitrogen Scavenging drug,
`determine whether to administer a nitrogen scavenging drug,
`and treat nitrogen retention disorders.
`15 Claims, 3 Drawing Sheets
`
`1 of 22
`
`

`

`US 9,095,559 B2
`Page 2
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`2003/O1952.55 A1
`2004/0229948 A1
`2005/0273359 A1
`2006, O1356.12 A1
`2008. O1195.54 A1
`2010, 0008859 A1
`2010, OO16207 A1
`2012/0022157 A1
`2012fO220661 A1
`2013,0210914 A1
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`2014/O142186 A1
`
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`4/2001 Eggers
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`10/2003 Summar
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`12/2005 Young
`6, 2006 Ferrante
`5, 2008 Jalan et al.
`1/2010 Scharschmidt
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