Granted Patent B2

US 12,734,137 · App. 16/864,955 · Granted Sep 15, 2026

Inventors: Stephen J. Farr (Orinda, CA); Bradley S. Galer (West Chester, PA)

Assignee: ZOGENIX INTERNATIONAL LIMITED

A61K31/137A61K9/0053A61K9/7023A61K31/19A61K31/357A61K31/551A61K45/06A61P25/08A61K9/0095A61K9/08

Abstract

Claims (25)

1 . A method of treating seizures associated with Lennox-Gastaut syndrome (LGS) in a patient suffering from LGS, comprising:

administering an oral dose of fenfluramine or a pharmaceutically acceptable salt thereof to the patient in an amount in a range of 0.2 mg/kg/day to 0.8 mg/kg/day up to a maximum of 30 mg/day.

2 . The method of claim 1 , wherein the oral dose is a liquid formulation.

3 . The method of claim 2 , wherein the oral dose consists essentially of fenfluramine or a pharmaceutically acceptable salt thereof as the active ingredient.

4 . The method of claim 1 , further comprising administering a co-therapeutic agent selected from the group consisting of carbamazepine, ethosuximide, fosphenytoin, lamotrigine, levetiracetam, phenobarbital, progabide, topiramate, stiripentol, valproic acid, verapamil, clobazam, clonazepam, diazepam, ethyl loflazepate, lorazepam, midazolam and a pharmaceutically acceptable salt thereof.

5 . The method of claim 1 , wherein the instances of seizures are reduced in frequency as compared to the patient suffering from LGS without an oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof.

6 . The method of claim 1 , wherein the instances of seizures are reduced in duration as compared to the patient suffering from LGS without an oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof.

7 . The method of claim 1 , wherein the instances of seizures are reduced in severity as compared to the patient suffering from LGS without an oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof.

8 . The method of claim 1 , wherein the oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof, is administered daily for two or more days.

9 . The method of claim 1 , wherein the oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof, is administered daily for at least one week.

10 . The method of claim 1 , wherein the oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof, is administered daily for at least four weeks.

11 . The method of claim 1 , wherein prior to the treatment, the Lennox-Gastaut syndrome (LGS) patient is refractory to conventional antiepileptic medications.

12 . A method of treating seizures associated with Lennox-Gastaut syndrome (LGS) in a patient suffering from LGS, comprising:

administering an oral solution of fenfluramine or a pharmaceutically acceptable salt thereof to the patient in an amount in a range of 0.2 mg/kg/day to 0.8 mg/kg/day up to a maximum of 30 mg/day; and

administering a drug selected from the group consisting of stiripentol, clobazam, valproate and combinations thereof.

13 . The method of claim 12 , wherein the oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof, is administered daily for two or more days.

14 . The method of claim 12 , wherein the oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof, is administered daily for at least one week.

15 . A method of treating seizures associated with Lennox-Gastaut syndrome (LGS) in a patient suffering from LGS, comprising:

administering an oral dose of fenfluramine or a pharmaceutically acceptable salt thereof to the patient in an amount in a range of 0.2 mg/kg/day to 0.8 mg/kg/day up to a maximum of 30 mg/day; and

administering a therapeutically effective amount of stiripentol to the patient.

16 . The method of claim 15 , wherein the oral dose of fenfluramine is in a liquid formulation.

17 . The method of claim 15 , wherein the oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof, is administered in a divided dose twice daily for two or more days.

18 . The method of claim 15 , wherein the oral dose of fenfluramine, or a pharmaceutically acceptable salt thereof, is administered daily for at least one week.

19 . The method of claim 1 , further comprising diagnosing the patient as having Lennox-Gastaut syndrome (LGS) based on the presence of specific clinical symptoms, signs, and findings on an electroencephalogram (EEG) of the patient prior to administering the oral dose of fenfluramine or a pharmaceutically acceptable salt thereof.

20 . The method of claim 1 , wherein the seizures are selected from the group consisting of tonic-axial seizures, atonic (drop) seizures, absence seizures, myoclonic seizures, generalized tonic-clonic seizures, and focal seizures.

Assignments (2)

Continuity (3)

References Cited (400)