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Method of treatment with tradipitant

a treatment method and technology of tradipitant, applied in the direction of dermatological disorders, drug compositions, nervous disorders, etc., can solve the problems of substance dependence, anxiety, nausea/vomiting, pruritus,

Inactive Publication Date: 2019-09-26
VANDA PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a method of treating pruritus (a skin condition that causes itching) by giving a patient a medication called tradipitant. The treatment involves giving the medication in a specific way and at a certain frequency to achieve and maintain a certain concentration in the patient's blood. The medication can be given in a daily dose of 100 to 400 mg, depending on the patient's needs. The treatment can help reduce the symptoms of pruritus. A use of tradipitant for treating pruritus and a medicine containing tradipitant are also described.

Problems solved by technology

Chronic pruritus affects millions of people worldwide and represents a serious and unmet medical need.
An inappropriate over-expression of SP either in nervous tissue or peripherally could result in pathological conditions such as substance dependence, anxiety, nausea / vomiting, and pruritus.

Method used

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  • Method of treatment with tradipitant
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  • Method of treatment with tradipitant

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0018]A phase II proof of concept clinical study (Study ID VP-VLY-686-2101, “Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis”) was conducted, investigating the safety and efficacy of tradipitant as a monotherapy in the treatment of chronic pruritus in patients with atopic dermatitis.

[0019]Despite a highly significant and clinically meaningful improvement from baseline by tradipitant (40.5 mm improvement from baseline, p<0.0001) as measured on a 100 mm unit Visual Analog Scale (VAS) for itch, a very high placebo effect (36.5 mm improvement from baseline, p<0.0001) on the change from baseline led to no statistical difference from placebo. However, subsequent analysis of population PK samples across all patients in the study revealed significant and clinically meaningful responses across multiple outcomes evaluated in individuals with higher levels of tradipitant exposure at the time of their pruritus assessments.

[0020]The pre...

example 2

[0033]In one study, healthy subject participants were orally administered 85 mg tradipitant on study day 3, and then 85 mg tradipitant Q12H on study days 4-16. Plasma concentration levels of tradipitant were measured on each of day 3, day 7, and day 11.

[0034]This study illustrated that administration of 85 mg tradipitant qd (on day 3) produced an average plasma concentration over hours 0-12 that was about 50% of the plasma concentration observed in the PM group in Example 1. On days 7 and 11, the average plasma concentration over hours 0-12 following administration of 85 mg bid (specifically, Q12H) tradipitant was about 150% of the plasma concentration observed in the PM group in Example 1. The average plasma concentration over hours 0-12 at each point was determined by dividing the AUC for hours 0-12 (in (hr.)×(ng / mL)) by 12 hours.

[0035]These results indicate that in patients suffering pruritus, e.g., pruritus associated with atopic dermatitis, patients can be treated by orally adm...

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Abstract

This application relates to a method of treatment with tradipitant, and more particularly, to a method of treatment of pruritus with tradipitant.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of co-pending U.S. application Ser. No. 15 / 553,394, filed 24 Aug. 2017, which is a US national stage under 35 USC § 371 of international patent Application No. PCT / US2016 / 021015, filed 4 Mar. 2016, which in turn claims the benefit of U.S. Provisional Applications No. 62 / 128,472, filed 4 Mar. 2015, and No. 62 / 232,644, filed 25 Sep. 2015, each of which is incorporated herein as though fully set forth.BACKGROUND[0002]Chronic pruritus affects millions of people worldwide and represents a serious and unmet medical need. The itch sensation is believed to be induced at least in part through the action of the endogenous neuropeptide substance P (SP), through the binding at NK-1Rs expressed on multiple skin cells.[0003]The NK-1R is expressed throughout different tissues of the body, with major activity found in neuronal tissue. SP and NK-1R interactions in neuronal tissue regulate neurogenic inflammation locally ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/444A61K31/4439A61P17/04A61K9/00
CPCA61P17/04A61K9/0053A61K31/444A61K31/4439A61P25/04A61P25/22A61P25/30A61P17/00A61P29/00A61P1/08A61K9/20A61K9/48
Inventor POLYMEROPOULOS, MIHAEL H.LICAMELE, LOUIS WILLIAM
Owner VANDA PHARMA INC