# US 2021/0275512 A1 · Pridopidine for treating drug induced dyskinesias

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- Number: US 2021/0275512 A1
- Document ID: US20210275512A1
- Status: Published application
- Kind: A1
- Application number: 17/315,667
- Filed: 2021-05-10
- Published: 2021-09-09
- Earliest claimed: 2017-09-08
- Assignees: Prilenia Neurotherapeutics Ltd.
- Applicants: Prilenia Neurotherapeutics Ltd.
- Inventors: Michal GEVA; Aric Orbach; Michael Hayden
- Web page: https://patentgrep.com/patent/US20210275512A1

## CPC

- A61K 31/451: having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/13: Amines {(A61K31/04 takes precedence)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 25/16: Anti-Parkinson drugs
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention provides a method of treating a subject afflicted with a drug-induced movement disorder including levodopa-induced dyskinesia comprising periodically administering to the subject in need thereof an amount of pridopidine or pharmaceutically acceptable salt thereof effective to treat the subject. The invention further provides a method of treating a subject at risk of developing a drug-induced movement disorder, including levodopa-induced dyskinesia

## Claims

### Claim 1

A method of treating levodopa-induced dyskinesia (LID) in a subject in need thereof, comprising a combination therapy of administering to the subject pridopidine or pharmaceutically acceptable salt thereof, and amantadine.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is afflicted with Parkinson's disease.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject is afflicted with parkinsonism other than Parkinson's disease.

### Claim 4 (depends on 1)

The method of claim 1, wherein the subject is concurrently being treated with levodopa.

### Claim 5 (depends on 4)

The method of claim 4 wherein the pridopidine, amantadine and the levodopa are administered sequentially or contemporaneously.

### Claim 6 (depends on 4)

The method of claim 4 wherein the pridopidine and amantadine are administered after the levodopa is administered for a period of time.

### Claim 7 (depends on 6)

The method of claim 6, wherein the period of time is from 10 min to 18 hours.

### Claim 8 (depends on 7)

The method of claim 7, wherein the period of time is 10 min, 20 min, 30 min, 45 min, 1.0 hour, 2.0 hours, 6.0 hours, or 12 hours or 18 hours.

### Claim 9 (depends on 1)

The method of claim 1, wherein the pridopidine and amantadine are administered sequentially or contemporaneously.

### Claim 10 (depends on 1)

The method of claim 1 wherein pridopidine and the amantadine are co-formulated.

### Claim 11 (depends on 1)

The method of claim 1, wherein the pridopidine and the amantadine are administered in a separate pharmaceutical formulation.

### Claim 12 (depends on 4)

The method of claim 4, wherein the levodopa is administered after the pridopidine and amantadine are administered for a period of time.

### Claim 13 (depends on 1)

The method of claim 1, wherein the method further alleviates or reduce a symptom associated with the levodopa treatment.

### Claim 14 (depends on 1)

The method of claim 1, pridopidine or pharmaceutically acceptable salt thereof and amantadine have synergistic activity and are effective to alleviate or reduce a symptom associated with the levodopa treatment.

### Claim 15 (depends on 13)

The method of claim 13, wherein the symptom is abnormal movements, myoclonic jerks, irregular movements of extremities, gait, facial grimacing, ataxia, inability to sustain motor act, hand movement or balance, choreiform peak dose dyskinesia, or dystonic peak dose dyskinesia.

### Claim 16 (depends on 13)

The method of claim 13, wherein the symptom is bad quality on-time evoked by levodopa.

### Claim 17 (depends on 13)

The method of claim 13, wherein the administration of pridopidine and amantadine improves the symptom of the levodopa induced dyskinesia by at least 8%, by at least 20%, by at least 30% or by at least 50% as measured by MDS-UPDRS or UDysRS.

### Claim 18 (depends on 1)

The method of claim 1, wherein the pridopidine or pharmaceutically acceptable salt thereof and amantadine are administered via oral administration.

### Claim 19 (depends on 1)

The method of claim 1, wherein pridopidine or pharmaceutically acceptable salt thereof, and amantadine are administered once daily, twice daily, three times daily, four times daily, or less than once a day.

### Claim 20 (depends on 1)

The method of claim 1, wherein pridopidine is administered as a pridopidine salt.

### Claim 21 (depends on 19)

The method of claim 19, wherein the salt is pridopidine HCl salt.

### Claim 22 (depends on 1)

The method of claim 1, wherein pridopidine is administered in a daily dose of between 10-400 mg/day.

### Claim 23 (depends on 1)

The method of claim 1, wherein pridopidine is administered in a daily dose of between 150-400 mg/day.

### Claim 24 (depends on 1)

The method of claim 1, wherein the pridopidine is administered at a daily dose of 200 mg given in the form of pridopidine HCl.

### Claim 25 (depends on 1)

The method of claim 1, wherein the method further delays the onset of LID or reduce the risk of developing LID.

### Claim 26 (depends on 1)

The method of claim 1, wherein the subject is receiving levodopa for treatment of Parkinson's disease.

### Claim 27 (depends on 1)

The method of claim 1, wherein the pridopidine or pharmaceutically acceptable salt thereof is administered in equal doses, twice daily.

### Claim 28 (depends on 1)

The method of claim 1, wherein amantadine is administered at a daily dose of between 10 mg to 400 mg/day.

### Claim 29 (depends on 1)

The method of claim 1, wherein the weight ratio between the pridopidine and amantadine is between 1:20 to about 20:1.
