Claims for Patent: 10,772,880

Summary for Patent: 10,772,880

Title:	Method of treatment with tradipitant
Abstract:	This application relates to a method of treatment with tradipitant, and more particularly, to a method of treatment of pruritus with tradipitant.
Inventor(s):	Mihael H. Polymeropoulos, Louis William Licamele
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US16/430,514
Patent Claims:	1. A method of treating a disease or condition responsive to tradipitant therapy in an individual in need of treatment for such disease or condition, wherein the disease or condition responsive to tradipitant therapy is pain, a behavioral stressor, craving, nausea, vomiting, substance dependence, anxiety, pruritus, or atopic dermatitis comprising: administering about 170 mg/day of tradipitant to the individual for such time as required to achieve and maintain a tradipitant plasma concentration of at least about 175 ng/mL during said treatment. 2. The method of claim 1, wherein the administering step further comprises orally administering. 3. The method of claim 1, wherein the administering further comprises tradipitant dosing of 85 mg bid. 4. A method of administering tradipitant to an individual, afflicted with a disorder that is pain, a behavioral stressor, craving, nausea, vomiting, substance dependence, anxiety, pruritus, or atopic dermatitis, which comprises: orally administering to the individual tradipitant in a solid immediate release form comprising one or more pharmaceutically acceptable excipients, and tradipitant at a dose of 150 to 400 mg/day. 5. The method of claim 4, wherein the solid immediate release form is a capsule or a tablet. 6. The method of claim 4, wherein the dose of tradipitant is 150 to 400 mg once daily (qd). 7. The method of claim 4, wherein the dose of tradipitant is 75 to 200 mg twice daily (bid). 8. The method of claim 4, wherein the dose of tradipitant is 85 mg twice daily (bid) or 100 mg bid. 9. The method of claim 4, wherein the oral administration is continued to achieve and maintain an effective plasma concentration of tradipitant, wherein the effective plasma concentration of tradipitant is about 150 ng/mL or greater during treatment. 10. The method of claim 4, wherein the disorder is caused by an over-expression of substance P or over-stimulation of the neurokinin-1 (NK-1) receptor and ameliorated by administration of tradipitant. 11. The method of claim 9, wherein the effective plasma concentration of tradipitant is about 175 ng/mL or greater. 12. The method of claim 11, wherein the effective plasma concentration of tradipitant is about 200 ng/mL or greater. 13. The method of claim 12, wherein the effective plasma concentration of tradipitant is about 225 ng/mL or greater.