Patents by Inventor Bradley S. Galer
Bradley S. Galer has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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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: 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: 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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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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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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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: 20220016053Abstract: 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: ApplicationFiled: June 24, 2021Publication date: January 20, 2022Applicant: ZOGENIX INTERNATIONAL LIMITEDInventor: Bradley S. Galer
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Publication number: 20220008389Abstract: A method of treating and/or preventing symptoms of Rett syndrome (RTT) in a patient such as a patient previously diagnosed with Rett syndrome, by administering an effective dose of a 5-HT1D, 5-HT2A, 5-HT2C or sigma-1 receptor agonist (e.g., fenfluramine or its pharmaceutically acceptable salt) to that patient. RTT patients are treated at a preferred dose of less than about 1.0 mg/kg/day and may be administered as fenfluramine in an amount of between 0.2 to 0.8 mg/kg/day, to a maximum of 30 mg/day in a liquid oral dose.Type: ApplicationFiled: November 22, 2019Publication date: January 13, 2022Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Bradley S. GALER, Bret MEGARGEL
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Patent number: 10952976Abstract: 5-HT receptor agonists are useful in the treatment of a variety of diseases. Provided herein are methods of treating and/or reducing the occurrence of respiratory depression caused by an opioid in a human patient or patient population using a 5-HT receptor agonist, such as, for example, a 5-HT4 agonist (e.g., fenfluramine). Methods of stimulating one or more 5-HT4 receptors in the brain of a patient undergoing treatment with an opioid, wherein the patient is at risk of respiratory depression, 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: November 22, 2019Date of Patent: March 23, 2021Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Bradley S. Galer, Carl L. Faingold, Parthena Martin
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Publication number: 20200352886Abstract: The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.Type: ApplicationFiled: February 12, 2020Publication date: November 12, 2020Inventors: Jagat SINGH, Joseph Zev SHAINHOUSE, Bradley S. GALER, Robert Dominic KING-SMITH, Lisa Marie GRIERSON, Maria BURIAN, Jonathan WILKIN, Edward T. KISAK, John M. NEWSAM
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Publication number: 20200330406Abstract: 5-HT receptor agonists are useful in the treatment of a variety of diseases. Provided herein are methods of treating and/or reducing the occurrence of respiratory depression caused by an opioid in a human patient or patient population using a 5-HT receptor agonist, such as, for example, a 5-HT4 agonist (e.g., fenfluramine). Methods of stimulating one or more 5-HT4 receptors in the brain of a patient undergoing treatment with an opioid, wherein the patient is at risk of respiratory depression, 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: ApplicationFiled: November 22, 2019Publication date: October 22, 2020Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Bradley S. GALER, Carl L. FAINGOLD, Parthena Martin
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Publication number: 20200297665Abstract: 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: May 22, 2020Publication date: September 24, 2020Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Parthena MARTIN, Brooks M. BOYD, Arnold GAMMAITONI, Bradley S. Galer, Gail FARFEL
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Publication number: 20200276136Abstract: Provided herein is a method of treating a selected patient population, wherein the patient population is selected based on a determination that the patients have previously been non-responsive when treated with cannabidiol. In some embodiments, the method comprises selecting the patient based on a previously failed treatment with cannabidiol, based on lack of efficacy or tolerability. Pharmaceutical compositions and formulations for use in practicing the subject methods are also provided. The method comprises identifying a population of patients diagnosed with Dravet syndrome who were found previously to have been non-responsive when treated with cannabidiol.Type: ApplicationFiled: May 11, 2020Publication date: September 3, 2020Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Bradley S. GALER, Glenn MORRISON, Brooks M. BOYD
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Publication number: 20200253895Abstract: A method of treating and/or preventing symptoms of Lennox-Gastaut Syndrome (LGS) also known as Lennox Syndrome in a patient such as a patient previously diagnosed with Lennox Syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Lennox Syndrome patients are treated at a preferred dose of less than about 2.0 to about 0.01 mg/kg/day.Type: ApplicationFiled: May 1, 2020Publication date: August 13, 2020Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Stephen J. FARR, Bradley S. GALER
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Patent number: 10646441Abstract: The present invention provides DMSO-containing foamable formulations, methods for preparation, and methods of treatment. The formulations can provide good permeability and bioavailability at the target site. Preferably, the formulations are useful for treating osteoarthritis. In one embodiment, the invention provides a foamable formulation for topical use, said formulation comprising DMSO, polyalkylene glycol alkyl ether, an active agent, a monohydric lower alcohol, a diol, and water. Preferably, the active agent is a non-steroidal anti-inflammatory drug, such as diclofenac sodium or ibuprofen.Type: GrantFiled: November 30, 2017Date of Patent: May 12, 2020Assignee: NUVO PHARMACEUTICALS INC.Inventors: Servet Buyuktimkin, Nadir Buyuktimkin, Edward Kisak, Jagat Singh, John M. Newsam, Dominic King-Smith, Bradley S. Galer
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Patent number: 10517841Abstract: 5-HT receptor agonists are useful in the treatment of a variety of diseases. Provided herein are methods of treating and/or reducing the occurrence of respiratory depression caused by an opioid in a human patient or patient population using a 5-HT receptor agonist, such as, for example, a 5-HT4 agonist (e.g., fenfluramine). Methods of stimulating one or more 5-HT4 receptors in the brain of a patient undergoing treatment with an opioid, wherein the patient is at risk of respiratory depression, 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: June 5, 2019Date of Patent: December 31, 2019Assignee: ZOGENIX INTERNATIONAL LIMITEDInventors: Bradley S. Galer, Carl L. Faingold, Parthena Martin
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Publication number: 20190380979Abstract: 5-HT receptor agonists are useful in the treatment of a variety of diseases. Provided herein are methods of treating and/or reducing the occurrence of respiratory depression caused by an opioid in a human patient or patient population using a 5-HT receptor agonist, such as, for example, a 5-HT4 agonist (e.g., fenfluramine). Methods of stimulating one or more 5-HT4 receptors in the brain of a patient undergoing treatment with an opioid, wherein the patient is at risk of respiratory depression, 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: ApplicationFiled: June 5, 2019Publication date: December 19, 2019Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Bradley S. Galer, Carl L. Faingold, Parthena Martin
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Publication number: 20190269636Abstract: The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.Type: ApplicationFiled: August 27, 2018Publication date: September 5, 2019Inventors: Jagat SINGH, Joseph Zev SHAINHOUSE, Bradley S. GALER, Robert Dominic KING-SMITH, Lisa Marie GRIERSON, Maria BURIAN, Jonathan WILKIN, Edward T. KISAK, John M. NEWSAM
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Publication number: 20190091177Abstract: Provided herein is a method of treating a selected patient population, wherein the patient population is selected based on a determination that the patients have previously been non-responsive when treated with stiripentol. In some embodiments, the method comprises selecting the patient based on a previously failed treatment with stiripentol, based on lack of efficacy or tolerability. Pharmaceutical compositions and formulations for use in practicing the subject methods are also provided. The method comprises identifying a population of patients diagnosed with Dravet syndrome who were found previously to have been non-responsive when treated with stiripentol.Type: ApplicationFiled: September 24, 2018Publication date: March 28, 2019Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Bradley S. GALER, Glenn MORRISON, Brooks M. BOYD
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Publication number: 20190091176Abstract: Provided herein is a method of treating a selected patient population, wherein the patient population is selected based on a determination that the patients have previously been non-responsive when treated with cannabidiol. In some embodiments, the method comprises selecting the patient based on a previously failed treatment with cannabidiol, based on lack of efficacy or tolerability. Pharmaceutical compositions and formulations for use in practicing the subject methods are also provided. The method comprises identifying a population of patients diagnosed with Dravet syndrome who were found previously to have been non-responsive when treated with cannabidiol.Type: ApplicationFiled: September 24, 2018Publication date: March 28, 2019Applicant: ZOGENIX INTERNATIONAL LIMITEDInventors: Bradley S. GALER, Glenn MORRISON, Brooks M. BOYD