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(6) EP''neee Dysfunction in a Female, Including the Vasculogenic Symp USOO6756407B2 (12) United States Patent (10) Patent No.: US 6,756,407 B2 Heaton et al. (45) Date of Patent: Jun. 29, 2004 (54) METHOD AND COMPOSITIONS FOR THE 5,770,606 A 6/1998 El-Rashidy et al. ........ 514/284 TEYN2, E2 or (List continued on next page.) FOREIGN PATENT DOCUMENTS (75) Inventors: Jeremy P. W. Heaton, Gananoque EP O 172 697 A2 2/1986 A61K/31/435 (CA); Michael A. Adams, Kingston EP O 579 435 A1 1/1994 ... A61K/47/48 (CA) WO WO 87/04621 8/1987 .......... A61K/31/50 WO WO 93/23035 11/1993 .......... A61 K/31/40 (73) Assignee: Queen's University at Kingston, WO WO 94/22445 10/1994 .......... A61 K/31/48 Kingston (CA) OTHER PUBLICATIONS (*) Notice: Subject to any disclaimer, the term of this Davis, SR, “The role of androgens and the menopause in the patent is extended or adjusted under 35 female Sexual response', in International Journal of Impo U.S.C. 154(b) by 0 days. tence Research (1998 Stockton Press) vol. 10, Suppl. 2, S82-S83. (21) Appl. No.: 10/126,933 (List continued on next page.) (22) Filed: Apr. 22, 2002 Primary Examiner Thurman K. Page O O Assistant Examiner-Konata M. George (65) Prior Publication Data (74) Attorney, Agent, or Firm-Stephen J. Scribner; Carol US 2002/0193442 A1 Dec. 19, 2002 Miernicki Steeg Related U.S. Application Data (57) ABSTRACT (6)60 EP''NEEE- - - dysfunctionThe present ininvention a female, provide including a method the vasculogenic of treating symp.Sexual part of application No. 09/102987 filed on Jun. 22, 1998. toms of delayed vaginal engorgement, diminished vaginal lubrication, pain or discomfort with intercourse (51) Int. Cl." ....................... A61K31/19. A61K 31,557 (dyspareunia), diminished vaginal sensation, diminished (52) U.S. Cl 514/573; 514/284; 514/772.6 vaginal orgasm, diminished clitoral Sensation or diminished -rr. s s clitoral orgasm, or of combating vaginal pain by Stimulating (58) Field of Search ................................. 5143,53. peripheral pelvic nerve release of nitric oxide (NO). The /772. method comprises administering to a female in need of Such (56) References Cited treatment a therapeutically effective amount of a compound which acts on a mid-brain pathway to increase blood flow to U.S. PATENT DOCUMENTS the ilio-hypogastric-pudendal artery bed and Stimulate the release of nitric oxide (NO) from peripheral NANC nerve 2.818.855 A 1/1958 Miller ......................... 128/79 cells. The preferred compound for the method of this inven 4,127,118 A 11/1978 Latorre .... ... 128/79 4,521,421 A 6/1985 Foreman ..................... 514/267 tion is apomorphine or one of its pharmaceutically accept 4,521,521 A 6/1985 Abbott et al. ............... 436/517 able Salts, esters, or pro-drugs. Alternatively, the apomor 4,543.256 A 9/1985 Neumeyer .................. 514/280 phine is co-administered with an apomorphine-potentiating 4,687,773 A 8/1987 Neumeyer et al. .......... 514/280 amount of an androgen, preferably testosterone either prior 4,727,064 A 2/1988 Pitha ........................... 514/58 to, or concomitantly with, the administration of the apomor 4,801,587 A 1/1989 Voss et al. ... ... 514/248 phine. 5.242,391 A 9/1993 Place et al. ................... 604/60 5,270,323 A 12/1993 Milne, Jr. et al. ........... 514/309 19 Claims, 10 Drawing Sheets 4 3.5 9 3 O 9. $ 2.5 is 2 >- as 1.5 i C S 1 s O.5 O O 40 80 120 Apomorphine Dose (ug/kg) US 6,756.407 B2 Page 2 U.S. PATENT DOCUMENTS Lloyd, R.V. and Fields, K.L., “Regulation of dopamine 5,945,117 A * 8/1999 El-Rashidy et al. ........ 424/430 receptors in the MtT/W15 transplantable pituitary tumor by 6,395,744 B1 5/2002 Adams et al. .............. 514/284 estrogen,” Mol. Cell. Endocrinol. 44:133-139, Elsevier Sci 6,403,605 B1 6/2002 Heaton et al. entific Publishers Ireland, Ltd. (1986). PubMed/NCBI abstract, accessed Aug. 27, 2001, for: OTHER PUBLICATIONS Mathews, A., “Progress in the treatment of female sexual Derogatis, LR and B Conklin-Powers, “Psychological dysfunction,” J. PsychoSom. Res. 27:165-173, Elsevier Sci assessment measures of female Sexual functioning in clinical ence Ltd. (1983). trials”, in International Journal of Impotence Research PubMed/NCBI abstract, accessed Aug. 27, 2001, for: Tutten, (1998 Stockton Press) vol. 10, Suppl. 2, S111–116.* A. et al., “Discrepancies between genital responses and Fourcroy, Jean, “Discussion: Female Sexual function Subjective Sexual function during testosterone Substitution in mechanisms and models', in International Journal of Impo women with hypothalamic amenorrhea, PsychoSom. Med. tence Research (1998 Stockton Press) vol. 10, Suppl. 2, 58:234-241, American Psychosomatic Society (May-Jun. S98-S101. 1996). Fourcroy, JL, “ISSues and priorities in the development of Ferrari, F. et al., Influence of Apomorphine on Rat Female drug treatments for female Sexual dysfunction', in Interna Sexual Behaviour and its Relation with Induction of Ste tional Journal of Impotence Research (1998 Stockton Press) reotypy, Rivista di Farmacologia e Terapia VIII, pp. vol. 10, Suppl. 2, S121-S123.* 355-363 (1977). Goldstein, I, and Berman, JR, “Vasculogenic female Sexual Melis, Maria Rosaria et al., Dopamine and Sexual Behav dysfunction: Vaginal engorgement and clitoral erectile insuf iour, NeuroScience and Biobehavioral Reviews, vol. 19, No. ficiency Syndromes, in International Journal of Impotence 1, pp. 19-38 (1995). Research (1998 Stockton Press) vol. 10, Suppl. 2, Segraves, R. T. et al., Pharmacotherapy for Sexual Disor S84-S90. ders: Advantages and Pitfalls, Sexual and Marital Therapy, Harvard Scientific Corp., Harvard Scientific Acquires Rights vol. 13, No. 3, pp. 295-309 (1998). to Oral Treatment for Both Male & Female Sexual Dysfunc Tagliamonte et al., Pharm. Biochem. and Behavior vol. 2, tion pp. 1-3, (Jun. 12, 1998). (Downloaded from the Internet pp. 257–260 (1974). at http://biz.yahoo.com/.) Laduron et al., Biochem. Pharmacology, Vol. 28, pp. Heiman, JR, “Psychophysiological models of female sexual 2161–2165 (1979). response', in International Journal of Impotence Research Baldessarini et al., in Gessa et al., Apomorphine & Other (1998 Stockton Press) vol. 10, Suppl. 2, S94–S97.* Dopaminomimetics, Vol. 1, Basic Pharmacology, pp. Laan, E and Everaerd, W, “Physiological measures of vagi 219–288 (1981). nal vasocongestion', in International Journal of Impotence Lal et al., J. Neural Transmission, vol. 54, pp. 75-84 (1982). 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Journal of Impotence Research (1998 Stockton Press) vol. Pehek et al., Pharm. Biochem. and Behavior 31:201-208 10, Suppl. 2, S91-S93.* (1988). *This information was first presented at the Cape Cod Danjou et al., J. Pharmacol. Methods, vol. 21, pp. 61-69 Conference of May 20–31, 1997. The references were first (1989). published in the United Kingdom on Feb. 6, 1998 and Gancher et al., Am. Neurol, Vol. 26, pp. 232-238 (1989). distributed for overseas publication on May 6, 1998. Segraves R. T., Arch. Gen. Psych., vol. 46, pp. 275-284 PubMed/NCBI abstract, accessed Aug. 27, 2001, for: Davis, (1989). S.R., “The clinical use of androgens in female Sexual Durifet al., Eur. J. Clin. Pharmacology, vol. 41, pp. 493-494 disorders,” J. Sex. Marital Ther. 24:153-163, Brunner-Rou (1991). tledge (Jul.-Sep. 1998). Essink et al., J. Chromatography, vol., 570, pp. 419–424 PubMed/NCBI abstract, accessed Aug. 27, 2001, for: (1991). 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