Use of botulinum neurotoxin in the treatment of sialorrhea

Patent metadata

Field	Value
Publication number	US-12478663-B2
Application number	US-202218054407-A
Country	US
Kind code	B2
Filing date	Nov 10, 2022
Priority date	Mar 24, 2017
Publication date	Nov 25, 2025
Grant date	Nov 25, 2025

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 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 3 consecutive treatment cycles,
wherein 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,
wherein there is a time interval between consecutive treatment cycles of between 14 and 18 weeks,
and wherein the botulinum neurotoxin is injected into one site of each of the submandibular glands and into one site of each of the parotid glands, and wherein the patient is a child.

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 an aqueous composition having a botulinum neurotoxin concentration in the range between 45 and 55 U/mL.

4 . 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.

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 Cl, 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 sialorrhea or increased saliva production is further associated with a disease or condition selected from the group consisting of Amyotrophic lateral sclerosis (ALS), Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, stroke, traumatic brain injury (TBI), clozapine induced hypersalivation, Rett syndrome, Angelman syndrome, epileptic encephalopathy, brain tumors, total pharyngolaryngectomy, supracricoid laryngectomy, supraglottic laryngectomy, dementia, and intellectual disability.

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

11 . The method according to claim 1 , wherein the time interval is between 15 and 17 weeks.

12 . The method according to claim 11 , wherein the time interval is 16 weeks.

Assignees

• Merz Pharma Gmbh & Co Kgaa

Inventors

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

Classifications

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title

• A61P43/00

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

• A61P1/00

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