Methods of treating multiple sclerosis
AssigneeVanda Pharmaceuticals Inc.
InventorsAllitia DiBernardo, Tatiana Sidorenko, Michel Burcklen, Sivi Ouwerkerk-Mahadevan, Andrea Vaclavkova, Brian Patrick Hennessy, Hilke Kracker
Life of this patent
Estimating the term…
Abstract
The disclosure relates to methods of treating multiple sclerosis. Also provided are pharmaceutical products containing ponesimod, instructions for use of ponesimod, methods for selling a drug product containing ponesimod, and methods for reducing clinical management events before or during treatment of multiple sclerosis.
Claims29
A method for reducing clinical management events before or during treatment of multiple sclerosis in a patient in need thereof, comprising administering ponesimod in an amount and manner that is described in a drug product label for an approved drug product.
A method for concomitant treatment with a beta-blocker and ponesimod in a patient in need thereof, wherein the patient is being treated with the beta-blocker and ponesimod treatment is to be initiated, and wherein the patient has a resting heart rate of greater than 55 beats per minute during treatment with the beta-block and prior to initiation of ponesimod, comprising administering ponesimod without interruption to the beta-blocker treatment.
A method for concomitant treatment with a beta-blocker and ponesimod for a patient in need thereof, wherein the patient is being treated with the beta-blocker and ponesimod treatment is to be initiated, and wherein the patient has a resting heart rate of less than or equal to 55 beats per minute during treatment with the beta-block and prior to initiation of ponesimod, comprising interrupting the beta-blocker treatment until the patient's heart rate is greater than 55 beats per minute and initiating ponesimod treatment in a titration regimen comprising administering orally once daily 2 mg of ponesimod on days 1 and 2;
- 3 mg of ponesimod on days 3 and 4;
- 4 mg of ponesimod on days 5 and 6;
- 5 mg of ponesimod on day 7;
- 6 mg of ponesimod on day 8;
- 7 mg of ponesimod on day 9;
- 8 mg of ponesimod on day 10;
- 9 mg of ponesimod on day 11;
- and 10 mg of ponesimod on days 12, 13, and 14, followed by administering a 20 mg maintenance dose of ponesimod once daily thereafter, and reinitiating the beta-blocker after ponesimod has been up-titrated to the maintenance dosage.
A method of reinitiating treatment with ponesimod following a missed dose in a patient in need thereof, wherein the patient is being treated with an oral, once daily 20 mg maintenance dose and fewer than four consecutive maintenance doses have been missed, comprising resuming treatment with the maintenance dose.
A method of reinitiating treatment with ponesimod following a missed dose for a patient in need thereof, wherein the patient is being treated with titration doses comprising administering orally once daily 2 mg of ponesimod on days 1 and 2;
- 3 mg of ponesimod on days 3 and 4;
- 4 mg of ponesimod on days 5 and 6;
- 5 mg of ponesimod on day 7;
- 6 mg of ponesimod on day 8;
- 7 mg of ponesimod on day 9;
- 8 mg of ponesimod on day 10;
- 9 mg of ponesimod on day 11;
- and 10 mg of ponesimod on days 12, 13, and 14, followed by administering 20 mg of ponesimod once daily, and fewer than four consecutive titration doses have been missed, comprising resuming treatment with the first missed titration dose and resuming the titration at that dose and titration day.
A method of reinitiating ponesimod following a missed dose for a patient in need thereof, wherein the patient is being treated with an oral, once daily 20 mg maintenance dose or a 14-day titration regimen comprising administering orally once daily titration doses of 2 mg of ponesimod on days 1 and 2;
- 3 mg of ponesimod on days 3 and 4;
- 4 mg of ponesimod on days 5 and 6;
- 5 mg of ponesimod on day 7;
- 6 mg of ponesimod on day 8;
- 7 mg of ponesimod on day 9;
- 8 mg of ponesimod on day 10;
- 9 mg of ponesimod on day 11;
- and 10 mg of ponesimod on days 12, 13, and 14, and four or more consecutive maintenance doses or titration doses have been missed, comprising reinitiating ponesimod with the 14-day titration regimen.
Dependencies are inferred from the claim text.