US009220715B2 (12) United States Patent (10) Patent No.: US 9.220,715 B2 Demopulos et al. (45) Date of Patent: *Dec. 29, 2015 (54) TREATMENT OF ADDICTION AND A613 L/454 (2006.01) IMPULSE-CONTROL DISORDERS USING A613 L/485 (2006.01) PDE7 INHIBITORS (Continued) (71) Applicant: Omeros Corporation, Seattle, WA (US) (52) U.S. Cl. CPC ........... A6 IK3I/5513 (2013.01); A61 K3I/I35 (72) Inventors: Gregory A. Demopulos, Mercer Island, (2013.01); A61 K3I/I37 (2013.01); A61 K WA (US); George A. Gaitanaris, 31/197 (2013.01); A6IK3I/337 (2013.01); Seattle, WA (US); Roberto A61K 31/35 (2013.01); A61 K3I/357 Ciccocioppo, Camerino (IT) (2013.01); A61 K3I/381 (2013.01); A61 K 3 1/385 (2013.01); A61 K31/4015 (2013.01): (73) Assignee: Omeros Corporation, Seattle, WA (US) A61K 31/4025 (2013.01); A61 K31/4162 (*) Notice: Subject to any disclaimer, the term of this (2013.01); A61 K3I/4178 (2013.01); A61 K patent is extended or adjusted under 35 31/433 (2013.01); A61K 31/435 (2013.01); U.S.C. 154(b) by 0 days. A6 IK3I/44 (2013.01); A61 K3I/4439 (2013.01); A61 K3I/454 (2013.01); A61 K This patent is Subject to a terminal dis- 3 1/46 (2013.01); A61K3I/485 (2013.01); claimer. A6 IK3I/496 (2013.01); A61 K3I/4985 (2013.01); A61 K3I/505 (2013.01); A61 K (21) Appl. No.: 13/835,607 31/517 (2013.01); A6IK3I/519 (2013.01); (22) Filed: Mar 15, 2013 A61 K3I/527 (2013.01); A61K3I/53 (2013.01); A61 K3I/5377 (2013.01); A61 K (65) Prior Publication Data 3 I/55 (2013.01); A61K 45/06 (2013.01) US 2013/02675O2A1 Oct. 10, 2013 ( 58) Field of Classification Search Cl. TU, CPC ........... A61K31/5513; A61K 31/5377; A61 K 3 1/53: A61K 31/4985; A61K 31/496; A61 K Related U.S. Application Data 31/519; A61 K31/527; A61 K31/46; A61 K 31/435; A61 K31/4439; A61K 31/433; (63) Continuation-in-part of application No. 13/290,868, A61K 31/41.78: A61K 31/4162: A61 K filed on Nov. 7, 2011. 31/4025; A61K 31/35; A61K 45/06 (60) Provisional application No. 61/643,611, filed on May See application file for complete search history. 7, 2012, provisional application No. 61/482,994, filed on May 5, 2011, provisional application No. (56) References Cited 61/411,437, filed on Nov. 8, 2010, provisional U.S. PATENT DOCUMENTS application No. 61/411,431, filed on Nov. 8, 2010. 5,610,288 A 3, 1997 Rubenstein (51) Int. Cl. 5,718,709 A 2f1998 Considine et al. A 6LX3/553 (2006.01) (Continued) A 6LX3/5377 (2006.01) A6 IK3I/53 (2006.01) FOREIGN PATENT DOCUMENTS A6 IK3I/4985 (2006.01) A6 IK3I/496 (2006.01) BR O607402-2 A2 9, 2009 A 6LX3/59 (2006.01) DE 199 SO 647 A1 10, 1999 A 6LX3/527 (2006.01) (Continued) A6 IK3 L/46 (2006.01) A6 IK3I/435 (2006.01) OTHER PUBLICATIONS A6 IK3I/4439 (2006.01) Siuciak, J., et al., “Inhibition of the Striatum-Enriched A6 IK3I/433 (2006.01) Phosphodiesterase PDE10A: A Novel Approach to the Treatment of A6 IK3I/478 (2006.01) Psychosis.” Neuropharmacology 51:386-396 (2006). A6 IK3I/4I62 (2006.01) (Continued) A6 IK3I/4025 (2006.01) A6 IK3I/35 (2006.01) A6 IK 45/06 (2006.01) Primary Examiner — Renee Claytor A6 IK3I/35 (2006.01) (74) Attorney, Agent, or Firm — Marcia S. Kelbon A6 IK3I/37 (2006.01) A 6LX3/97 (2006.01) (57) ABSTRACT A6 IK3I/337 (2006.01) This disclosure is directed to treatment of addictions and A 6LX3L/357 (2006.01) primary impulse-control disorders using phosphodiesterase 7 A6 IK3I/38 (2006.01) (PDE7) inhibitors, alone or in combination with other thera A6 IK3I/385 (2006.01) peutic agents. A6 IK3I/405 (2006.01) A6 IK3I/44 (2006.01) 34 Claims, 47 Drawing Sheets US 9.220,715 B2 Page 2 (51) Int. Cl. EP 1348 701 A1 3f2002 A 6LX3L/505 (2006.01) E. 13. A 3.583 A 6LX3/57 (2006.01) EP 1775 298 A1 7/2005 A6 IK3I/55 (2006.01) ES 2308916 12/1987 RU 2351 371 4/2009 (56) References Cited WO WO 94.21244 9, 1994 WO WO 88,04399 6, 1998 U.S. PATENT DOCUMENTS WO WOOOf 682O3 11, 2000 WO WOOOf 68230 11, 2000 5,739,119 A 4, 1998 Galli et al. WO WOO1,29049 A2 4, 2001 5,759,829 A 6, 1998 Shewmaker et al. WO WOO1/32175 A1 5, 2001 5,789,573 A 8, 1998 Baker et al. WO WOO1/32618 A1 5. 2001 5,801,154 A 9, 1998 Baracchini et al. WO WOO1,34601 A2 5, 2001 6,146,876. A 1 1/2000 Robision et al. WO WOO1,364.25 A2 5, 2001 6,531.498 B1 3/2003 Eggenweiler et al. WO WOO1,62904 A1 8/2001 6,613,778 B1 9/2003 Eggenweiler et al. WO WOO 1/74.786 A1 10, 2001 6,617.357 B2 9/2003 Aubart et al. WO WOO1,982.74 A2 12/2001 6,649,592 B1 1 1/2003 Larson WO WOO2,28847 A1 4, 2002 6,737,436 B1 5/2004 Eggenweiler et al. WO WOO2,40449 A1 5. 2002 6,753,340 B2 6/2004 Vergne et al. WO WO O2/4O450 A1 5, 2002 6,818,651 B2 11/2004 Weinbrenner et al. WO WO O2/O74754 A1 9, 2002 6,838,559 B2 1/2005 Vaccaro et al. WO WO O2/O76953 A1 10, 2002 6,849,638 B2 2/2005 Stolle et al. WO WO O2/O85894 A1 10, 2002 6,852,720 B2 2/2005 Vergne et al. WO WO O2/085906 A2 10, 2002 6,884,800 B1 4/2005 Eggenweiler et al. WO WO O2/O87513 A2 11/2002 6,903,109 B2 6/2005 Heintzelman et al. WO WO O2/O87519 A2 11/2002 6,936,609 B2 8/2005 Ergilden et al. WO WO O2/O88079 A2 11/2002 6,958,328 B2 10/2005 Heintzelman et al. WO WO 02/088080 A2 11/2002 7,022,849 B2 4/2006 Pitts et al. WO WO 02/088138 A1 11, 2002 7,087.614 B2 8, 2006 Guo et al. WO WO 02/102313 A2 12/2002 7,122,565 B2 10/2006 Vergne et al. WO WO 02/102314 A2 12/2002 7,214,676 B2 5/2007 Bernardelli et al. WO WO O2/102315 A2 12/2002 7,268,128 B2 9/2007 Inoue et al. WO WO O2/O53975 A1 3f2003 7.491,742 B2 2/2009 Eggenweiler et al. WO WOO3,053975 A1 T 2003 7,498.334 B2 3/2009 Eggenweiler et al. WO WOO3,055882 A1 T 2003 7,579,455 B2 8/2009 Paolo et al. WO WOO3,057149 A2 7, 2003 7932,250 B2 4/2011 Inoue et al. WO WO 03/064389 A1 8, 2003 2002/0156064 A1 10, 2002 Aubart et al. WO WOO3,082.277 A1 10, 2003 2002fO198198 A1 12/2002 Bernardelli et al. WO WOO3,082839 A1 10, 2003 2003/0045557 A1 3/2003 Vergne et al. WO WO 03/088963 A1 10, 2003 2003/0092721 A1 5, 2003 Pitts et al. WO WO 2004/026818 A1 4, 2004 2003/00929.08 A1 5, 2003 Pitts et al. WO WO 2004/044196 A1 5, 2004 2003/010.0571 A1 5/2003 Vaccaro et al. WO WO 2004/065391 A1 8/2004 2003. O104974 A1 6, 2003 Pitts et al. WO WO 2004/111053 A1 12/2004 2003/01 19829 A1 6, 2003 Stolle et al. WO WO 2004/111054 A1 12/2004 2003/01628O2 A1 8/2003 Guo et al. WO WO 2006/004.04.0 A1 1/2006 2003/019 1167 A1 10/2003 Vergne et al. WO WO 2006/092691 A1 9, 2006 2003/0212089 A1 11/2003 Heintzelman et al. WO WO 2006/092692 A1 9, 2006 2004/0044212 A1 3f2004 Weinbrenner et al. WO WO 2007/038551 A2 4, 2007 2004/0082578 A1 4/2004 Heintzelman et al. WO WO 2007/047978 A2 4, 2007 2004/0106631 A1 6/2004 Bernardelli et al. WO WO 2007/063391 6, 2007 2004/O127707 A1 7, 2004 Sterk WO WO 2008, 113881 A1 9, 2008 2004/0249148 Al 12/2004 Ergüden et al. WO WO 2008, 130619 A2 10, 2008 2005/005968.6 A1 3/2005 Eggenweiler et al. WO WO 2008. 142550 A2 11/2008 2005/0148604 A1 7/2005 Inoue et al. WO WO 2009/140309 A2 11/2009 2005/0222138 A1 10, 2005 Ohhata et al. WO WO 2010/027975 A1 3f2010 2006/0116516 A1 6, 2006 Pitts et al. WO WO 2010/030851 A1 3f2010 2006/0128.707 A1 6/2006 Inoue et al. WO WO 2010.109148 A1 9, 2010 2006/O128728 A1 6/2006 Inoue et al. WO WO 2010/116088 A2 10, 2010 2006/0154949 A1 7/2006 Heintzelman et al. 2006/0229306 A1 10, 2006 Terricabras Belart et al. OTHER PUBLICATIONS 2007.0049558 A1 3, 2007 Bernardelli et al. 2007/OO72899 A1 3/2007 Johnson et al. Miro, X., et al., “Differential Distribution of cAMP-Specific 2007/0129388 A1 6, 2007 Rawson et al. Phosphodiesterase 7A mRNA in Rat Brain and Peripheral Organs.” 2007/0208029 A1 9, 2007 Barlow et al. Synapse, 40:201-214 (2001). 3:29:29: A. 2587 S. et al. 1 Reyes-Irrisari, E., et al., “Neuronal Expression of cAMP-Specific 2008/0260643 A1 10, 2008 iA cal Phosphodiesterase 7B mRNA in the Rat Brain.” Neuroscience 2008/0282364 A1 11/2008 Black et al.