# US 2021/0330610 A1 · Compositions and methods for treating seizure-induced sudden death

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- Number: US 2021/0330610 A1
- Document ID: US20210330610A1
- Status: Published application
- Kind: A1
- Application number: 16/340,009
- Filed: 2018-05-11
- Published: 2021-10-28
- Earliest claimed: 2018-05-11
- Assignees: Zogenix International Limited
- Applicants: Zogenix International Limited
- Inventors: Parthena Martin
- Web page: https://patentgrep.com/patent/US20210330610A1

## CPC

- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/166: having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
- A61K 31/18: Sulfonamides (compounds containing a para-N-benzene-sulfonyl-N- group A61K31/63)
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/36: Compounds containing methylenedioxyphenyl groups, e.g. sesamin
- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 31/404: Indoles, e.g. pindolol
- A61K 31/439: the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46)
- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61K 31/4468: having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
- A61K 31/4525: containing a five-membered ring with oxygen as a ring hetero atom
- A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
- A61K 31/5375: 1,4-Oxazines, e.g. morpholine
- A61K 31/551: having two nitrogen atoms, e.g. dilazep
- A61K 31/5513: 1,4-Benzodiazepines, e.g. diazepam {or clozapine}
- A61P 25/08: Antiepileptics; Anticonvulsants
- 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

5-HT receptor agonists are useful in the treatment of a variety of diseases. Provided herein are methods of reducing the incidence and/or severity of seizures in a human patient using a 5-HT receptor agonist, such as, for example, a 5-HT4 agonist (e.g., fenfluramine). Methods of treating epilepsy or epileptic encephalopathy, and/or reducing, ameliorating or eliminating incidence of SUDEP in a subject diagnosed with epilepsy by administering a 5-HT4 agonist (e.g., fenfluramine) to a subject in need thereof are provided. Pharmaceutical compositions for use in practicing the subject methods are also provided.

## Claims

### Claim at position 1

1-24. (canceled)

### Claim 25

A method of reducing likelihood of seizure-induced Sudden Unexpected Death in Epilepsy (SUDEP) in a human patient, comprising:
administering to the patient a therapeutically effective dose of a 5-HT4 agonist; and
allowing the 5-HT4 agonist to stimulate 5-HT4 receptors in the patient, thereby reducing the likelihood of SUDEP in the patient.

### Claim 26 (depends on 25)

The method of claim 25, wherein the 5-HT4 agonist is selected from the group consisting of fenfluramine, BIMU-8, Cisapride, Mosapride, Prucalopride, Renzapride, RS-67506, Tegaserod, Zacopride, Metoclopramide, and Sulpiride, or a pharmaceutically acceptable salt thereof.

### Claim 27 (depends on 25)

The method of claim 25, wherein the 5-HT4 agonist is fenfluramine, or a pharmaceutically acceptable salt thereof.

### Claim 28 (depends on 27)

The method of claim 27, further comprising:
diagnosing the patient as being particularly susceptible to suffering from SUDEP;
wherein fenfluramine is administered as an adjunctive therapeutic agent.

### Claim 29 (depends on 28)

The method of claim 28, wherein the therapeutically effective dose of fenfluramine is selected from the group consisting of 0.2 mg/kg/day to 0.08 mg/kg/day up to a 30 mg maximum daily dose.

### Claim 30 (depends on 29)

The method of claim 29, wherein the therapeutically effective dose of fenfluramine is administered in an oral liquid dosage form.

### Claim 31 (depends on 30)

The method of claim 30, further comprising:
administering to the patient an effective dose of stiripentol or a pharmaceutically acceptable salt thereof.

### Claim 32 (depends on 31)

The method of claim 31, further comprising:
administering to the patient an effective dose of valproate or a pharmaceutically acceptable salt thereof.

### Claim 33 (depends on 32)

The method of claim 32, further comprising:
administering to the patient an effective dose of clobazam or a pharmaceutically acceptable salt thereof.

### Claim 34 (depends on 27)

The method of claim 27, wherein fenfluramine is the only pharmaceutically active drug administered to the patient.

### Claim 35

A method of reducing the length of the mean post-ictal depression (PID) period in a human patient, comprising:
administering to the patient a therapeutically effective dose of a 5-HT4 agonist; and
allowing the 5-HT4 agonist to stimulate 5-HT4 receptors in the patient, thereby inhibiting PID period in the patient.

### Claim 36 (depends on 35)

The method of claim 35, wherein the 5-HT4 agonist is selected from the group consisting of fenfluramine, BIMU-8, Cisapride, Mosapride, Prucalopride, Renzapride, RS-67506, Tegaserod, Zacopride, Metoclopramide, and Sulpiride, or a pharmaceutically acceptable salt thereof.

### Claim 37 (depends on 35)

The method of claim 35, wherein the 5-HT4 agonist is fenfluramine, or a pharmaceutically acceptable salt thereof.

### Claim 38 (depends on 37)

The method of claim 37, further comprising:
diagnosing the patient as being particularly susceptible to suffering from PID;
wherein fenfluramine is administered as an adjunctive therapeutic agent.

### Claim 39 (depends on 38)

The method of claim 38, wherein the therapeutically effective dose of fenfluramine is selected from the group consisting of 0.2 mg/kg/day to 0.08 mg/kg/day up to a 30 mg maximum daily dose.

### Claim 40 (depends on 39)

The method of claim 39, wherein the therapeutically effective dose of fenfluramine is administered in an oral liquid dosage form.

### Claim 41 (depends on 40)

The method of claim 40, further comprising:
administering to the patient an effective dose of stiripentol or a pharmaceutically acceptable salt thereof.

### Claim 42 (depends on 41)

The method of claim 41, further comprising:
administering to the patient an effective dose of valproate or a pharmaceutically acceptable salt thereof.

### Claim 43 (depends on 42)

The method of claim 42, further comprising:
administering to the patient an effective dose of clobazam or a pharmaceutically acceptable salt thereof.

### Claim 44 (depends on 37)

The method of claim 37, wherein fenfluramine is the only pharmaceutically active drug administered to the patient.