Patents Assigned to ZOGENIX INTERNATIONAL LIMITED
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Patent number: 11786487Abstract: Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.Type: GrantFiled: May 19, 2021Date of Patent: October 17, 2023Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Stephen J. Farr, Brooks Boyd
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Patent number: 11759440Abstract: Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.Type: GrantFiled: July 1, 2021Date of Patent: September 19, 2023Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Stephen J. Farr, Brooks Boyd
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Patent number: 11673852Abstract: Metabolism-resistant fenfluramine analogs are provided. The subject fenfluramine analogs find use in the treatment of a variety of diseases. For example, methods of treating epilepsy by administering a fenfluramine analog to a subject in need thereof are provided. Also provided are methods of suppressing appetite in a subject in need thereof. Pharmaceutical compositions for use in practicing the subject methods are also provided.Type: GrantFiled: April 5, 2022Date of Patent: June 13, 2023Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Stephen J. Farr, Brooks M. Boyd
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Publication number: 20230165810Abstract: Provided are methods of inhibiting spreading depolarization in a subject by administering a sigma-1 agonist or a sigma-1 positive modulator to the subject. In some cases the subject is administered fenfluramine as the sigma-1 positive modulator. In some cases, the subject has been diagnosed with epilepsy, traumatic brain injury, migraines, stroke, ischemic attacks, hypoxia or an increased risk of sudden unexpected death in epilepsy (SUDEP), or a combination thereof.Type: ApplicationFiled: November 22, 2022Publication date: June 1, 2023Applicants: ZOGENIX INTERNATIONAL LIMITED, BAYLOR COLLEGE OF MEDICINEInventors: Bradley S. GALER, Stephen J. FARR, Thaddeus Cromwell REEDER, Jeff NOEBELS
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Patent number: 11634377Abstract: Methods of preparing a fenfluramine active pharmaceutical ingredient are provided. Aspects of the method include (a) hydrolyzing a 2-(3-(trifluoromethyl)phenyl)acetonitrile composition to produce a 2-(3-(trifluoromethyl)phenyl)acetic acid composition; (b) reacting the 2-(3-(trifluoromethyl)phenyl)acetic acid composition with acetic anhydride and a catalyst to produce a 1-(3-(trifluoromethyl)phenyl)propan-2-one composition; and (c) reductively aminating the 1-(3-(trifluoromethyl)phenyl)propan-2-one composition with ethylamine using a borohydride reducing agent to produce a fenfluramine composition. Also provided are compositions and pharmaceutical ingredients prepared according to the subject methods including a pharmaceutically acceptable salt of fenfluramine and having less than 0.2% by weight in total of trifluoromethyl regioisomers.Type: GrantFiled: January 27, 2021Date of Patent: April 25, 2023Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Derek J. Londesbrough, Marc W. Andersen
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Patent number: 11612574Abstract: Provided is a method of treating a patient infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), comprising: determining the patient has been infected with SARS-CoV-2; and administering to the patient a therapeutically effective dose of fenfluramine.Type: GrantFiled: June 24, 2021Date of Patent: March 28, 2023Assignee: ZOGENIX INTERNATIONAL LIMITEDInventor: Bradley S. Galer
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Publication number: 20230093150Abstract: Disclosed herein are methods of improving cognitive function in a patient as measured by, for example, improvement in score on a validated scale that measures cognitive function, such as the Behavior Rating Inventory of Executive Function (BRIEF), by administering the test to a patient and obtaining a pre-treatment test score, treating the patient with fenfluramine or its pharmaceutically acceptable salt, and after treatment, re-administering the test of cognitive function to the patient and obtaining a post-treatment score, to allow observation of an improvement in the test score. In some embodiments, the patient is also being treated for the symptoms of epilepsy.Type: ApplicationFiled: May 5, 2022Publication date: March 23, 2023Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Glenn MORRISON, Arnold GAMMAITONI, Brooks M. BOYD
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Publication number: 20230078820Abstract: Methods of modifying disease progression of a neurodegenerative disease or condition associated with demyelination, insufficient myelination, or underdevelopment of myelin sheath are also described herein.Type: ApplicationFiled: August 25, 2022Publication date: March 16, 2023Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: John Chang-Eun CHA, Thaddeus Cromwell REEDER
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Publication number: 20230076320Abstract: Functional analogs of fenfluramine are provided. Methods of treating Dravet syndrome with (?) norfenfluramine are disclosed. Pharmaceutical compositions for use in practicing the subject methods are also provided.Type: ApplicationFiled: August 31, 2022Publication date: March 9, 2023Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Parthena MARTIN, Brooks M. BOYD, Arnold GAMMAITONI, Bradley S. GALER, Gail FARFEL
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Patent number: 11571397Abstract: 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.Type: GrantFiled: May 11, 2018Date of Patent: February 7, 2023Assignee: ZOGENIX INTERNATIONAL LIMITEDInventor: Parthena Martin
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Publication number: 20220370381Abstract: Functional analogs of fenfluramine are provided. The subject fenfluramine functional analogs find use in the treatment of a variety of diseases. For example, methods of treating epilepsy by administering a fenfluramine analog to a subject in need thereof are provided. Also provided are methods of treating a neurodegenerative disease in a subject in need thereof. Pharmaceutical compositions for use in practicing the subject methods are also provided.Type: ApplicationFiled: June 17, 2022Publication date: November 24, 2022Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Parthena MARTIN, Brooks M. BOYD, Arnold GAMMAITONI, Bradley S. Galer, Gail FARFEL
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Patent number: 11458111Abstract: A method of treating symptoms of a subtype of epilepsy, e.g., Dravet syndrome, in a patient diagnosed with a subtype of epilepsy, by administering to the patient an effective dose of a fenfluramine formulation in combination with a ketogenic diet over a period of time sufficient to reduce or completely eliminate seizures in the patient. Also provided are compositions and kits finding use in practicing embodiments of the methods.Type: GrantFiled: May 4, 2020Date of Patent: October 4, 2022Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Khawla Abu-Izza, David Hickman, Glenn Morrison, Brooks M. Boyd
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Publication number: 20220289663Abstract: Metabolism-resistant fenfluramine analogs are provided. The subject fenfluramine analogs find use in the treatment of a variety of diseases. For example, methods of treating epilepsy by administering a fenfluramine analog to a subject in need thereof are provided. Also provided are methods of suppressing appetite in a subject in need thereof. Pharmaceutical compositions for use in practicing the subject methods are also provided.Type: ApplicationFiled: April 5, 2022Publication date: September 15, 2022Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Stephen J. FARR, Brooks M. BOYD
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Patent number: 11406606Abstract: Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.Type: GrantFiled: January 7, 2022Date of Patent: August 9, 2022Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Stephen J. Farr, Brooks Boyd
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Publication number: 20220226262Abstract: A method of treating and/or preventing symptoms of Doose syndrome in a patient such as a patient previously diagnosed with Doose syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Doose syndrome patients are treated at a preferred dose of less than about 10.0 to about 0.01 mg/kg/day.Type: ApplicationFiled: April 5, 2022Publication date: July 21, 2022Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Brooks BOYD, Stephen J. FARR, Bradley GALER
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Publication number: 20220193082Abstract: Formulations for and methods of treatment of Dravet syndrome that avoid side effects are disclosed. The formulations comprise a 5-HT receptor agonists which does not agonize selected 5-HT receptor subtypes, and in particular does not agonize the receptor subtype 5-HT2B. Also disclosed are combinations of such 5-HT receptor agonists. Also disclosed are combinations of such 5-HT receptor agonists and SSRIs, SNRIs, and triptans for treating co-morbidities associated with Dravet syndrome.Type: ApplicationFiled: January 19, 2022Publication date: June 23, 2022Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Peter De Witte, Lieven Lagae, Jo Sourbron, Bradley S. Galer
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Patent number: 11325882Abstract: Metabolism-resistant fenfluramine analogs are provided. The subject fenfluramine analogs find use in the treatment of a variety of diseases. For example, methods of treating epilepsy by administering a fenfluramine analog to a subject in need thereof are provided. Also provided are methods of suppressing appetite in a subject in need thereof. Pharmaceutical compositions for use in practicing the subject methods are also provided.Type: GrantFiled: May 8, 2020Date of Patent: May 10, 2022Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Stephen J. Farr, Brooks M. Boyd
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Publication number: 20220133652Abstract: Described herein is a method of improving seizure control in a patient experiencing uncontrolled seizures persisting 10 minutes or more, comprising administering fenfluramine or a pharmaceutically acceptable salt, base, acid or amine thereof, at a dose of from 0.2 to 1.2 m/kg/day for a period of about 12 hours to about 7 days to a patient having been put into a therapeutic, medically-induced coma via a general anesthetic; and after about 12 hours to about 7 days, weaning the patient from the general anesthetic and assessing whether the seizure control has improved as compared to a pre-treatment time point. The patient experiencing seizures may have epilepsy or epileptic encephalopathy that has led to established status epilepticus (SE), refractory status epilepticus (RSE) or super-refractory status epilepticus (SRSE).Type: ApplicationFiled: February 14, 2020Publication date: May 5, 2022Applicants: ZOGENIX INTERNATIONAL LIMITEDInventors: David MILLET, Bradley S. GALER
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Publication number: 20220125743Abstract: Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.Type: ApplicationFiled: January 7, 2022Publication date: April 28, 2022Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Stephen J. FARR, Brooks BOYD
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Publication number: 20220096514Abstract: Provided is a method of treating thymidine kinase 2 (TK2) deficiency in a subject by administering deoxycytidine (dC) and deoxythymidine (dT). The method can include administering dC and dT to a subject in doses between 200 mg/kg/day and 600 mg/kg/day for each of dC and dT. In some cases, the method includes performing test administrations with lower dosages of dC and dT, administering adjusted doses after administration of the target doses, or a combination thereof.Type: ApplicationFiled: July 29, 2021Publication date: March 31, 2022Applicant: ZOGENIX INTERNATIONAL LIMITEDInventor: Joanne QUAN