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).

  • Publication number: 20230165810
    Abstract: 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: Application
    Filed: November 22, 2022
    Publication date: June 1, 2023
    Applicants: ZOGENIX INTERNATIONAL LIMITED, BAYLOR COLLEGE OF MEDICINE
    Inventors: Bradley S. GALER, Stephen J. FARR, Thaddeus Cromwell REEDER, Jeff NOEBELS
  • Patent number: 11612574
    Abstract: 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: Grant
    Filed: June 24, 2021
    Date of Patent: March 28, 2023
    Assignee: ZOGENIX INTERNATIONAL LIMITED
    Inventor: Bradley S. Galer
  • Publication number: 20230076320
    Abstract: 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: Application
    Filed: August 31, 2022
    Publication date: March 9, 2023
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Parthena MARTIN, Brooks M. BOYD, Arnold GAMMAITONI, Bradley S. GALER, Gail FARFEL
  • Publication number: 20220370381
    Abstract: 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: Application
    Filed: June 17, 2022
    Publication date: November 24, 2022
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Parthena MARTIN, Brooks M. BOYD, Arnold GAMMAITONI, Bradley S. Galer, Gail FARFEL
  • Publication number: 20220193082
    Abstract: 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: Application
    Filed: January 19, 2022
    Publication date: June 23, 2022
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Peter De Witte, Lieven Lagae, Jo Sourbron, Bradley S. Galer
  • Publication number: 20220133652
    Abstract: 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: Application
    Filed: February 14, 2020
    Publication date: May 5, 2022
    Applicants: ZOGENIX INTERNATIONAL LIMITED
    Inventors: David MILLET, Bradley S. GALER
  • Publication number: 20220016053
    Abstract: 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: Application
    Filed: June 24, 2021
    Publication date: January 20, 2022
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventor: Bradley S. Galer
  • Publication number: 20220008389
    Abstract: 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: Application
    Filed: November 22, 2019
    Publication date: January 13, 2022
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Bradley S. GALER, Bret MEGARGEL
  • Patent number: 10952976
    Abstract: 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: Grant
    Filed: November 22, 2019
    Date of Patent: March 23, 2021
    Assignee: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Bradley S. Galer, Carl L. Faingold, Parthena Martin
  • Publication number: 20200352886
    Abstract: 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: Application
    Filed: February 12, 2020
    Publication date: November 12, 2020
    Inventors: 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
  • Publication number: 20200330406
    Abstract: 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: Application
    Filed: November 22, 2019
    Publication date: October 22, 2020
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Bradley S. GALER, Carl L. FAINGOLD, Parthena Martin
  • Publication number: 20200297665
    Abstract: 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: Application
    Filed: May 22, 2020
    Publication date: September 24, 2020
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Parthena MARTIN, Brooks M. BOYD, Arnold GAMMAITONI, Bradley S. Galer, Gail FARFEL
  • Publication number: 20200276136
    Abstract: 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: Application
    Filed: May 11, 2020
    Publication date: September 3, 2020
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Bradley S. GALER, Glenn MORRISON, Brooks M. BOYD
  • Publication number: 20200253895
    Abstract: 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: Application
    Filed: May 1, 2020
    Publication date: August 13, 2020
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Stephen J. FARR, Bradley S. GALER
  • Patent number: 10646441
    Abstract: 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: Grant
    Filed: November 30, 2017
    Date of Patent: May 12, 2020
    Assignee: NUVO PHARMACEUTICALS INC.
    Inventors: Servet Buyuktimkin, Nadir Buyuktimkin, Edward Kisak, Jagat Singh, John M. Newsam, Dominic King-Smith, Bradley S. Galer
  • Patent number: 10517841
    Abstract: 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: Grant
    Filed: June 5, 2019
    Date of Patent: December 31, 2019
    Assignee: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Bradley S. Galer, Carl L. Faingold, Parthena Martin
  • Publication number: 20190380979
    Abstract: 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: Application
    Filed: June 5, 2019
    Publication date: December 19, 2019
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Bradley S. Galer, Carl L. Faingold, Parthena Martin
  • Publication number: 20190269636
    Abstract: 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: Application
    Filed: August 27, 2018
    Publication date: September 5, 2019
    Inventors: 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
  • Publication number: 20190091177
    Abstract: 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: Application
    Filed: September 24, 2018
    Publication date: March 28, 2019
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Bradley S. GALER, Glenn MORRISON, Brooks M. BOYD
  • Publication number: 20190091176
    Abstract: 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: Application
    Filed: September 24, 2018
    Publication date: March 28, 2019
    Applicant: ZOGENIX INTERNATIONAL LIMITED
    Inventors: Bradley S. GALER, Glenn MORRISON, Brooks M. BOYD