Administration regime for nitrocatechols

• US 10,065,944 B2
• Filed: 08/09/2013
• Issued: 09/04/2018
• Est. Priority Date: 02/11/2011
• Status: Active Grant

• Current Assignee: BIAL Portela & Ca, SA
• Original Assignee: BIAL Portela & Ca, SA
• Inventors: Soares Da Silva, Patricio Manuel Vieira Araujo, Nunes, Teresa Lucia Silva Pereira, Wright, Lyndon Christopher, Palma, Pedro Nuno Leal, Learmonth, David Alexander
• Primary Examiner(s): Ivanova, Svetlana M
• Application Number:
  US13/963,621
• Publication Number:
  US 20130324578A1
• Time in Patent Office: 1,852 Days
• Field of Search: None
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/10 Antioedematous agents; Diuretics
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: C07D 413/12 linked by a chain containing hetero atoms as chain links

Abstract

A compound of formula (I)

where R₁, R₂, X, Y, n, m, R₃, R₄, R₅, R₆ and R₇ are as defined herein, for use in the prophylaxis or treatment of a central and peripheral nervous system disorder, wherein the compound of formula (I) is administered prior to sleep, before bedtime or at bedtime.

Claims

1. A method of treatment of Parkinson'"'"'s disease, comprising administering to a human patient suffering from said disease a therapeutically effective amount of compound 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4] oxadiazol-5-yl]3-nitrobenzene-1,2-diol or a pharmaceutically acceptable salt, ester, carbamate or phosphate thereof,

wherein the compound is administered in combination with a catecholamine drug, wherein the catecholamine drug is levodopa, and the compound is administered in a single daily dose at least one hour before or after the last daily dose of the catecholamine drug.

2. The method according to claim 1, wherein the catecholamine drug is administered sequentially or concomitantly with an aromatic L-amino acid decarboxylase inhibitor (AADCi).

3. The method according to claim 2, wherein the AADCi is carbidopa or benserazide.

4. A method of treatment of Parkinson'"'"'s disease, comprising administering to a human patient suffering from said disease a therapeutically effective amount of compound 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4]oxadiazol-5-yl]-3-nitrobenzene-1,2-diol, or a pharmaceutically acceptable salt thereof,

wherein the compound is administered in combination with a catecholamine drug, wherein the catecholamine drug is levodopa, and the compound is administered in a single daily dose at least one hour before or after the last daily dose of the catecholamine drug.

5. The method according to claim 4, wherein the catecholamine drug is administered sequentially or concomitantly with an aromatic L-amino acid decarboxylase inhibitor (AADCi).

6. The method according to claim 5, wherein the AADCi is carbidopa or benserazide.