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Treatment of tardive dyskinesia with pyridoxal 5'-phosphate

A technology for pyridoxal phosphate and dyskinesia, which is applied in the directions of organic active ingredients, medical preparations containing active ingredients, and pharmaceutical formulations, and can solve problems such as toxicity and side effects

Inactive Publication Date: 2010-03-31
MEDICURE INT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Vitamin B6 therapy in TD is limited by vitamin B6 toxicity, giving high doses of vitamin B6 can lead to toxicity and side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Safety and tolerability of pyridoxal 5'-phosphate enteric-coated tablets

[0037] A phase I, single-center, single-dose, open-label, serially ascending-dose study was conducted in fasting healthy subjects to evaluate the safety and tolerability of pyridoxal 5'-phosphate in enteric-coated tablet form, Doses are 250mg, 750mg and 4000mg.

[0038] A total of 32 healthy adult subjects signed study-specific informed consent and were confined to the clinical research unit; of these subjects, 24 were dosed (6 subjects per dose level; 3 males and 3 females) and enrolled in the study; all of these enrolled subjects completed the study. Subjects were confined to the SFBC Anapharm Clinical Research Facility from at least 12 hours prior to dosing until 24 hours after blood draw.

[0039] Subjects enrolled in this study are generally community members. Subject screening steps included consent, include / exclude checks, demographics, medical history, medication history, physical exam...

Embodiment 2

[0050] Using P5P to treat tardive dyskinesia

[0051] A double-blind, placebo-controlled crossover study in patients with neuroleptic-induced TD. The patients were divided into 5 groups: control group, vitamin B6 treatment group (400mg), low-dose P5P group (100mg), middle-dose P5P group (250mg) and high-dose P5P group (750mg). All doses were given orally. Treat daily.

[0052] All groups treated with P5P had increased scores on subscales of the Extrapyramidal Syndrome Rating Scale, more specifically Parkinsonism and Dyskinesia grades, compared with the control and vitamin B6-treated groups. Groups treated with medium or high doses of P5P had significantly higher scores compared to the low dose group. The scores of the groups treated with medium or high doses of P5P were not significantly different from each other.

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Abstract

This invention relates to treatment of Tardive Dyskinesia through the administration of pyridoxal 5'-phosphate. The treatment may be an oral administration of 100 - 4000 mg / day, for example, 100-750 mg / day or about 250 mg / day. Also provided is the use of pyridoxal 5'-phosphate for the preparation of a medicament for the treatment of tardive dyskinesia, kits comprising pyridoxal 5'-phosphate for the treatment of tardive dyskinesia, and combination drugs for the treatment of tardive dyskinesia.

Description

[0001] Cross References to Related Applications [0002] This application claims priority based on Canadian Patent Application 2,590,603, filed May 28, 2007, which is incorporated herein by reference. technical field [0003] The present invention relates to the treatment of tardive dyskinesia by administration of pyridoxal 5'-phosphate. Background technique [0004] Tardive dyskinesia (TD) is characterized by a series of repetitive, uncontrollable movements of predominantly facial muscles. The frequency of TD is directly related to the use of antipsychotics. Some of the factors associated with susceptibility to TD are older age, female sex, presence of major deficit disorder, exposure to antipsychotics, use of anticholinergic / antiparkinsonian drugs, and history of extrapyramidal syndrome. Patients with schizophrenia are often treated with neuroleptic drugs, which often cause TD. The incidence of TD is 20% higher in individuals receiving neuroleptic drug therapy (Bhoopath...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/675A61P25/14
CPCA61K31/675A61P25/14
Inventor A·D·弗里森D·J·雷默
Owner MEDICURE INT INC
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