Use of botulinum neurotoxin in the treatment of sialorrhea

Patent metadata

Field	Value
Publication number	US-10709772-B2
Application number	US-201816129311-A
Country	US
Kind code	B2
Filing date	Sep 12, 2018
Priority date	Mar 24, 2017
Publication date	Jul 14, 2020
Grant date	Jul 14, 2020

Abstract

This invention relates to improved uses of botulinum neurotoxins in the treatment of sialorrhea or diseases or conditions relating to increased saliva production. In particular are botulinum neurotoxins disclosed which are administered into parotid and submandibular glands in a dose ratio between 1.45 to 1 and 1.7 to 1.

First claim

The invention claimed is:

1. A method for treating a disease or condition associated with sialorrhea or increased saliva production in a patient, the method comprising administering a therapeutically effective amount of a botulinum neurotoxin by injection into the parotid glands and submandibular glands of the patient, in at least two consecutive treatment cycles, wherein:
the disease or condition is further associated with Parkinson's disease, Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, Amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury (TBI), clozapine induced hypersalivation, Rett syndrome, Angelman syndrome, epileptic encephalopathy, brain tumours, total pharyngolaryngectomy, supracricoid laryngectomy, supraglottic laryngectomy, dementia, or intellectual disability;
there is a time interval between at least two consecutive treatment cycles of between 10 and 20 weeks; and
the ratio between the amount of the botulinum neurotoxin administered into each of the parotid glands and each of the submandibular glands is between 1.45 to 1 and 1.7 to 1.

2. The method according to claim 1 , wherein the total dose of said botulinum neurotoxin administered into the parotid glands and submandibular glands is between 70 U and 110 U.

3. The method according to claim 1 , wherein said botulinum neurotoxin is administered in 0.3 to 0.5 mL per injection site into the submandibular glands and in 0.5 to 0.7 mL per injection site into the parotid glands.

4. The method according to claim 1 , wherein said botulinum neurotoxin is injected into one site of each submandibular gland and/or into one site of each parotid gland.

5. The method according to claim 1 , wherein the botulinum neurotoxin is injected into the parotid glands and submandibular glands using ultrasound guidance.

6. The method according to claim 1 , wherein said botulinum neurotoxin is a botulinum neurotoxin complex.

7. The method according to claim 1 , wherein said botulinum neurotoxin is the neurotoxic component of a botulinum neurotoxin complex, wherein said neurotoxic component is devoid of any other protein component of the Clostridium botulinum neurotoxin complex.

8. The method according to claim 1 , wherein said botulinum neurotoxin is selected from the group of botulinum neurotoxin serotypes consisting of botulinum neurotoxin serotype A, botulinum neurotoxin serotype B, botulinum neurotoxin serotype C1, botulinum neurotoxin serotype D, botulinum neurotoxin serotype E, botulinum neurotoxin serotype F, and botulinum neurotoxin serotype G.

9. The method according to claim 1 , wherein the disease or condition is associated with stroke.

10. The method according to claim 1 , wherein the botulinum neurotoxin is administered in an equeous composition having a botulinum neurotoxin concentration in the range between 45 and 55 U/mL.

11. The method according to claim 1 , wherein the disease or condition is associated with Parkinson's disease.

12. The method according to claim 1 , wherein the disease or condition is associated with Progressive Supranuclear Palsy.

13. The method according to claim 1 , wherein the disease or condition is associated with Corticobasal Degeneration.

14. The method according to claim 1 , wherein the disease or condition is associated with Multiple System Atrophy.

15. The method according to claim 1 , wherein the disease or condition is associated with traumatic brain injury (TBI).

16. The method according to claim 1 , wherein the disease or condition is associated with Amyotrophic lateral sclerosis (ALS).

17. The method according to claim 1 , wherein the disease or condition is associated with clozapine induced hypersalivation.

18. The method according to claim 1 , wherein the disease or condition is associated with Rett syndrome or Angelman syndrome.

19. The method according to claim 1 , wherein the disease or condition is associated with epileptic encephalopathy.

20. The method according to claim 1 , wherein the disease or condition is associated with brain tumours.

Assignees

• Merz Pharma Gmbh & Co Kgaa

Inventors

• Csikos Janos
• Pulte Irena
• Althaus Michael
• Krüer Markus
• Wegener Nico

Classifications

• A61P1/00

  Drugs for disorders of the alimentary tract or the digestive system · CPC title

• Y02A50/30

  Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61K38/4893 Primary

  Botulinum neurotoxin (3.4.24.69) · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title