MAOI

AstraZeneca caps patient out-of-pocket costs at $35 per month for its US inhaled respiratory portfolio

Retrieved on: 
Lunedì, Marzo 18, 2024
Biotechnology, Medical Devices, Health, Pharmaceutical, Health Insurance, Diabetes, Blood pressure, Depression, Arrhythmia, Hypokalemia, ICS, Anaphylaxis, Angioedema, Congress, Moyamoya disease, AstraZeneca, MAOI, Hyperthyroidism, Risk, ECG, Incidence, Headache, Immunosuppression, Patient, QT interval, Chronic obstructive pulmonary disease, Inhalation, Chickenpox, Research, Budesonide, System, Liver, Cough, Rash, Infection, Salbutamol, Water, Cataract, Adrenal gland, Measles, Safety, Bronchospasm, COPD, Glaucoma, Use, Catherine Disher, Fatality, Monoamine oxidase inhibitor, Hypertension, Medicine, Pharmaceutical industry

AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.

Key Points: 
  • AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.
  • We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone.
  • The Company will continue to provide discounts and rebates off the list price to help patients afford its inhaled respiratory medicines.
  • AstraZeneca remains dedicated to transforming patient outcomes, while ensuring access and affordability of our innovative medicines.

Terran Biosciences Receives Notice of Allowance for Four US Patents Including for the World’s First New Salts and Polymorphs of Psilocybin, potentially enabling future 505(b)(2) pathway

Retrieved on: 
Venerdì, Dicembre 8, 2023
Men, Research, Other Health, Pharmaceutical, Consumer, Mental Health, Clinical Trials, Science, Biotechnology, Alternative Medicine, FDA, Health, Other Science, Psilocybin, Vomiting, MAOI, Depression, Safety, GMP, Chemistry, DMT, Patient, Therapy, Nausea, Hydrogen chloride, Patent, Blood pressure, Pharmaceutical industry, Terran

Two of these patents cover the world’s first new forms of psilocybin (psilocybin HCl and psilocybin edisylate) and their method of use in treating neurological and psychiatric disorders, including depression.

Key Points: 
  • Two of these patents cover the world’s first new forms of psilocybin (psilocybin HCl and psilocybin edisylate) and their method of use in treating neurological and psychiatric disorders, including depression.
  • The clinical trials of psilocybin to date have been limited to using the older forms of zwitterionic psilocybin described in the historical literature.
  • Terran plans to use its new forms of psilocybin to pursue a rapid 505(b)(2) FDA approval pathway if one of the existing forms of psilocybin currently in clinical trials is approved.
  • Terran believes this new discovery may be the most stable form of tabernanthalog monofumarate.

Jay Glazer Teams Up with Supernus Pharmaceuticals to Raise Awareness of ADHD and his Qelbree® Journey

Retrieved on: 
Lunedì, Ottobre 16, 2023
Diagnosis, Constipation, Mania, Xerostomia, ADHD, Vomiting, Personality, Bipolar disorder, Somnolence, Perseverance, Fatigue, Medicine, Vital signs, Heart rate, Nausea, Headache, FDA, Insomnia, Appetite, Television, Blood pressure, Depression, Patient, MAOI, Theophylline, Boxed warning, Solidarity, Irritability, Child, Attention deficit hyperactivity disorder predominantly inattentive, Dietary supplement, Nursing, Residential care, Birth control, Viloxazine

“I’m partnering with Supernus to help others overcome the stigmas associated with ADHD and help those diagnosed understand they are not alone,” says Glazer.

Key Points: 
  • “I’m partnering with Supernus to help others overcome the stigmas associated with ADHD and help those diagnosed understand they are not alone,” says Glazer.
  • Since I was diagnosed later in life as an adult, it has been difficult trying to find the right treatment.
  • “Supernus stands with the ADHD community year-round, and especially during ADHD Awareness Month, offering solidarity, support and understanding for those living with the condition,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals.
  • Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older.

Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms

Retrieved on: 
Domenica, Settembre 10, 2023
Blood pressure, Psych, MAOI, Fatigue, Research and development, Central nervous system, Depression, Senior, AE, Mania, State University of New York Upstate Medical University, Xerostomia, Aes, ADHD, Trae tha Truth, Constipation, Medicine, Appetite, CNS, OLE, AISRS, Vomiting, Administration, Insomnia, Vital signs, Patient, Child, Boxed warning, Psychiatry, Theophylline, Nausea, Somnolence, Behavioral medicine, Heart rate, Upper respiratory tract infection, FDA, Headache, Function (mathematics), Irritability, Bipolar disorder, Food, Safety, Dietary supplement, Birth control, Pharmaceutical industry, Copper, Residential care, Viloxazine

Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.

Key Points: 
  • Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.
  • “These data demonstrate Qelbree’s ability to enhance efficacy when co-administered with stimulants, including significant improvement during evening hours when the effects of stimulants often wear off following their morning dose.
  • Patients ADHD symptoms improved from 37.9 (6.34) to 19.7 (12.16) on the Adult ADHD Investigator Symptom Rating Scale (AISRS), representing average symptom reduction of -18.2 (11.54).
  • Patients executive function improved from 70.4 (10.94) to 58.3 (16.19) on the BRIEF-A Global Executive Composite scale, representing improvement in executive function of -12.9 (13.48).

Axsome Therapeutics Highlights Commitment to Innovating Treatments for Mental Health Conditions with Presentations at Psych Congress 2023

Retrieved on: 
Giovedì, Settembre 7, 2023
Blood pressure, Psychiatry, MAOI, Pregnancy, Depression, Psychosis, Heart failure, Medication, Eating disorder, Diarrhea, Suicide, Xerostomia, Anxiety, Spinal cord, Stroke, Brain, Medicine, Psychological abuse, History, HCP, Tablet, Vitamin, Insomnia, Dizziness, Risk, Perspiration, Liver, Neoplasm, Heart rate, Head injury, Headache, Death, Irritability, Agitation, Bipolar disorder, Breast milk, DSM-IV codes, Birth control, Pharmaceutical industry, Dietary supplement, Drug, Liquor, Residential care, Health insurance, Solriamfetol, Mental, Dextromethorphan/bupropion

NEW YORK, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations of data from its CNS portfolio at the 2023 U.S. Psych Congress, being held in Nashville, Tenn. from September 6-10. The presentations demonstrate the Company’s commitment to continued innovation to address unmet needs in difficult-to-treat CNS disorders.

Key Points: 
  • Tell your HCP about all your medical conditions, including if you:
    have problems with your liver or kidneys.
  • have a history of seizure, stroke, eating disorder, head injury, or have a tumor in your brain or spinal cord.
  • have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction.
  • Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.

Tris Pharma Announces US District Court Upholds Validity of QuilliChew ER® Patents; Rules Teva Infringes Tris Patents

Retrieved on: 
Giovedì, Agosto 18, 2022
Ketan, Death, Breast milk, ADHD, MAOI, Depression, The, Raynaud syndrome, Lists of diseases, Syncope, PKU, CNS, Sudden death, Abbreviated New Drug Application, Growth, United States district court, Phenylalanine, District, Suicide, Numb, Pain, Theft, ANDA, Attention deficit hyperactivity disorder, Court, Patient, Narcolepsy, Stroke, Finger, Chest pain, Degenerative disease, Priapism, Methylphenidate, Central nervous system, Peripheral vasculopathy, Spasticity, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Child, District court, Cerebral palsy, Heart rate, Blood pressure, Color, Tablet, Phenylketonuria, Boxed warning, Ventricular septal defect, CII, Allergy, Attention deficit hyperactivity disorder predominantly inattentive, Multiple sclerosis, Montana District Courts, Temperature, Teva, Generic drug, Pharmaceutical industry, Residential care, Birth control, Tris

The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris's patent portfolio providing exclusivity until August 2033.

Key Points: 
  • The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris's patent portfolio providing exclusivity until August 2033.
  • "The decision of the District Court not only confirms the validity and infringement of our QuilliChew ER patents, but also validates the innovative nature of our LiquiXRtechnology which we utilized to develop QuilliChew ER and our other branded ADHD medications."
  • QuilliChew ER is approved for treatment of ADHD in people 6 years and older.
  • Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking QuilliChew ER.

Tris Pharma announces U.S. Court of Appeals for the Federal Circuit Affirms Validity of Quillivant XR® Patents; Rules Teva Infringes Tris Patents

Retrieved on: 
Mercoledì, Luglio 20, 2022
Ketan, XR, Multiple sclerosis, Chest pain, ANDA, Attention deficit hyperactivity disorder predominantly inattentive, Federal Circuit Court of Australia, Priapism, Research, The, Raynaud syndrome, Ventricular septal defect, Hydrogen chloride, List, Finger, CNS, Methylphenidate, Spasticity, Narcolepsy, Lists of diseases, Tris, Boxed warning, Degenerative disease, Numb, Suicide, ADHD, Abbreviated New Drug Application, Peripheral vasculopathy, Mania, CII, CAFC, Patient, Cerebral palsy, Psychosis, Pain, Color, Depression, United States Court of Appeals for the Federal Circuit, Attention deficit hyperactivity disorder, MAOI, District, Attention, Breast milk, United States district court, Actavis, Child, Generic drug, Risk management, Pharmaceutical industry, Medical device, Residential care, Birth control, Healthcare

"We are very pleased with the ruling of the CAFC, which affirms the strength of our patents protecting Quillivant XR.

Key Points: 
  • "We are very pleased with the ruling of the CAFC, which affirms the strength of our patents protecting Quillivant XR.
  • You and your doctor should decide if you will take Quillivant XR or breastfeed
    What should I avoid while taking Quillivant XR?
  • Quillivant XR should not be taken with MAOI medicines or if you stopped taking an MAOI in the last 14 days.
  • Quillivant XR may cause serious side effects, including:
    Other serious side effects include:
    Painful and prolonged erections (priapism) have occurred with methylphenidate.

Axsome Therapeutics Completes U.S. Acquisition of Sunosi® (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

Retrieved on: 
Lunedì, Maggio 9, 2022
Jazz Pharmaceuticals, Narcolepsy, Department, Somnolence, Headache, CPAP, Appetite, Insurance, University, EMA, Press release, EDS, NASDAQ, Disability, European Medicines Agency, Obstructive sleep apnea, GLOBE, CNS, Excessive daytime sleepiness, OSA, Food, Research, Depression, Medical school, Epworth Sleepiness Scale, Â, Patient, Medical University of South Carolina, Neurology, FDA, Incidence, Airway obstruction, Anxiety, FCCP, Regulation of tobacco by the U.S. Food and Drug Administration, Dopamine, Adult, MAOI, Quality of life, Continuous positive airway pressure, Wakefulness, Psychiatry, Central nervous system, Nausea, Risk, Acquisition, Therapy, Pharmaceutical industry, Solriamfetol, Neuroscience, Medicine, MD

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Key Points: 
  • Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).
  • The effect of excessive daytime sleepiness on individuals with narcolepsy and obstructive sleep apnea includes functional impairment, reduced quality of life, and increased risk for occupational and motor vehicle accidents.
  • Axsome recognizes the importance of providing patients with EDS associated with narcolepsy and OSA affordable access to Sunosi.
  • Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Axsome Therapeutics Completes U.S. Acquisition of Sunosi® (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

Retrieved on: 
Lunedì, Maggio 9, 2022
Accident, Jazz Pharmaceuticals, Narcolepsy, Department, Somnolence, Headache, CPAP, Appetite, Insurance, University, EMA, Press release, EDS, NASDAQ, Disability, European Medicines Agency, Obstructive sleep apnea, CNS, Excessive daytime sleepiness, OSA, Food, Research, Depression, Medical school, Epworth Sleepiness Scale, Patient, Medical University of South Carolina, Neurology, FDA, Incidence, Airway obstruction, Anxiety, FCCP, Regulation of tobacco by the U.S. Food and Drug Administration, Dopamine, Adult, MAOI, Quality of life, Continuous positive airway pressure, Wakefulness, Psychiatry, Central nervous system, Nausea, Risk, Acquisition, Therapy, Pharmaceutical industry, Solriamfetol, Neuroscience, Medicine, MD

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Key Points: 
  • Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).
  • The effect of excessive daytime sleepiness on individuals with narcolepsy and obstructive sleep apnea includes functional impairment, reduced quality of life, and increased risk for occupational and motor vehicle accidents."
  • Axsome recognizes the importance of providing patients with EDS associated with narcolepsy and OSA affordable access to Sunosi.
  • Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults

Retrieved on: 
Lunedì, Maggio 2, 2022
Clinical Global Impression, U.S. Securities and Exchange Commission, Section 13, Epilepsy, Private Securities Litigation Reform Act, Associate, Nasdaq, Torticollis, CNS, Company, Securities Exchange Act of 1934, Food, Safety, Depression, Dyskinesia, ADHD, Central nervous system disease, Patient, Security (finance), Parkinson's disease, Government, Risk, Adult, FDA, Prescription, Regulation of tobacco by the U.S. Food and Drug Administration, MAOI, Ageing, Attention deficit hyperactivity disorder, CEO, News, Research, Migraine, Growth, Central nervous system, Phase, Pharmaceutical industry, PD, Viloxazine

The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.

Key Points: 
  • The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.
  • While manychildren with ADHDoutgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.
  • The approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.
  • "Today's approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients.