Methods for treating uterine disorders

• US 20040175399A1
• Filed: 03/03/2003
• Published: 09/09/2004
• Est. Priority Date: 03/03/2003
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Schiffman, Rhett M.
• Granted Patent: US 8,071,550 B2
• Time in Patent Office: Days
• US Class Current: 424/239.1
• CPC Class Codes: A61K 38/4893 Botulinum neurotoxin (3.4.24.69)
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• CPC Class Codes: A61P 21/02 Muscle relaxants, e.g. for tetanus or cramps
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A method for treating uterine disorders, including hyperplasic, hypertonic, cystic and/or neoplastic uterine gland tissue by local administration of a botulinum toxin to or to the vicinity of the afflicted uterine tissue.

Claims

1. A method for treating a uterine glandular disorder, the method comprising the step of local administration of between about 10⁻

3 U/kg and about 2000 U/kg of a Clostridial neurotoxin to a uterine gland, thereby treating a uterine gland disorder.

2. The method of claim 1, wherein the Clostridial neurotoxin is a botulinum toxin.

3. The method of claim 2, wherein the botulinum toxin is administered in an amount of between about 10⁻

2 U/kg and about 200 U/kg.

4. The method of claim 2, wherein the botulinum toxin is administered in an amount of between about 10⁻

1 U/kg and about 35 U/kg.

5. The method of claim 2, wherein the botulinum toxin is selected from the group consisting of botulinum toxins types A, B, C, D, E, F and G.

6. The method of claim 2, wherein the botulinum toxin is botulinum toxin type A.

7. The method of claim 2, wherein local administration of the botulinum toxin is carried out by implantation of a botulinum toxin implant into or onto a uterine gland.

8. The method of claim 1, wherein the uterine gland disorder is selected from the group consisting of precancerous uterine tissue and uterus cancer.

9. A method for treating a uterine gland disorder, the method comprising the step of local administration of between about 10⁻

3 U/kg and about 2000 U/kg of a botulinum toxin type A to a uterus of a human patient, thereby treating a uterine gland disorder by reducing a secretion from the uterine gland. and treating a uterine gland disorder.

10. A method for treating a uterine fibroid, the method comprising the step of local administration of between about 10⁻

3 U/kg and about 2000 U/kg of a botulinum toxin to a uterine fibroid, thereby treating a uterine fibroid.

11. A method for treating a uterine gland disorder, the method comprising the step of local administration of a botulinum toxin to a uterine gland or to the vicinity of a precancerous uterus tissue, thereby causing a reduction in the size and/or activity of a hyperplastic, hypertonic or neoplastic uterine gland tissue.

12. A method for treating a uterine gland disorder, the method comprising the step of local administration of a therapeutic amount of a botulinum toxin to a hyperplastic, hypertonic or neoplastic uterine gland tissue, thereby causing a reduction in the diameter of the hyperplastic, hypertonic or neoplastic uterine gland tissue of between about 20% and about 100%.

13. A method for preventing development of a uterine gland neoplasm, the method comprising the step of local administration of a botulinum toxin to a hyperplasic or hypertonic uterine gland tissue, thereby reducing a secretion from the hyperplasic or hypertonic uterine gland tissue and preventing the hyperplasic or hypertonic uterine gland tissue from developing into a neoplasm.

14. A method for preventing development of a uterine neoplasm, the method comprising the step of local administration of a therapeutic amount of a botulinum toxin type A to the precancerous hyperplasic or hypertonic uterine gland tissue of a human patient, thereby preventing development of a uterine gland neoplasm.

15. The method of claim 14 wherein the hyperplasic uterine tissue comprises a substrate for the botulinum toxin selected from the group of vesicle membrane docking proteins consisting of a 25 kiloDalton synaptosomal associated protein (SNAP-25), synaptobrevin and syntaxin.

16. A method for preventing development of a uterine carcinoma, the method comprising the step of local administration of between about 10⁻

3 U/kg and about 2000 U/kg of a botulinum toxin type A to a hyperplastic uterus tissue of a human patient, wherein the hyperplastic uterus tissue comprises a substrate for the botulinum toxin selected from the group of vesicle membrane docking proteins consisting of a 25 kiloDalton synaptosomal associated protein (SNAP-25), synaptobrevin and syntaxin, and wherein the botulinum toxin acts upon the substrate to reduce a secretion from the hyperplasic uterus tissue.