Brexpiprazole

Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults

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Martedì, Maggio 28, 2024
Research, Mental Health, Neurology, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Patient, Phase, Commercialization, Diagnosis, Lundbeck, Brexpiprazole, Post-traumatic stress disorder, Safety, PTSD, Fifth Edition, DSM-IV codes, Medication, Society, ASCP, Sertraline, Multimedia, Annual general meeting, Pharmaceutical industry

In Trial 072, while the primary endpoint was not met, reductions in PTSD symptom severity with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071.

Key Points: 
  • In Trial 072, while the primary endpoint was not met, reductions in PTSD symptom severity with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071.
  • The safety and tolerability results were consistent with the known profile of brexpiprazole in its approved indications and what has been observed in other clinical trials.
  • In Trial 071, the least squares mean change was -19.2 with brexpiprazole in combination with sertraline (p=0.0007 versus sertraline plus placebo) and -13.6 with sertraline plus placebo.
  • “We’re hopeful that brexpiprazole in combination with sertraline can become an approved treatment option for appropriate patients living with PTSD.”

Doctors and Advocates Call for Better Testing and Labeling of Drugs for People with Obesity

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Martedì, Novembre 28, 2023
Drug, OAC, Obesity, Schizophrenia, Depression, Safety, Organization, Risk, Disease, Patient, The Obesity Society, FDA, Metabolism, Plasma protein binding, Society, Brexpiprazole, Education, Dietary supplement

The statement, which can be found at obesityaction.org/statement-drug-approval-labeling , calls for the U.S. FDA to close gaps in the testing and approval process for drugs intended for use by people with obesity for conditions other than obesity.

Key Points: 
  • The statement, which can be found at obesityaction.org/statement-drug-approval-labeling , calls for the U.S. FDA to close gaps in the testing and approval process for drugs intended for use by people with obesity for conditions other than obesity.
  • The statement also urges drug companies that are currently marketing drugs that have issues with safety or effectiveness for people with obesity to update their labeling immediately to provide appropriate usage instructions.
  • This means that every day, people with obesity are using FDA-approved drugs without full assurance that they are safe and effective for them.
  • Drugs that may present issues for people with obesity include drugs in many familiar categories, including emergency birth control, depression, and pain relief.

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

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Lunedì, Novembre 6, 2023
Research, Mental Health, Neurology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Behavioral neuroscience, Attention, Headache, Incidence, CMAI, Food, Mini–Mental State Examination, DSM-IV codes, Brexpiprazole, OPDC, MD, Psychiatry, Food and Drug Administration Amendments Act of 2007, Deficit spending, Verbal aggression, Dementia, Multimedia, Medicine, Interview, Pneumonia, Somnolence, Lundbeck, Locomotion, Commercialization, JAMA Neurology, Cachexia, Screaming, Caregiver, Passive-aggressive behavior, Aggression, Saint Louis University School of Medicine, MMSE, Heart, Ōtsuka, Akathisia, Contra body movement, Agitation, Medication, Tearing, Anxiety, IPA, Patient, Diagnosis, Disease, Restless, Pharmaceutical industry, Nursing, Birth control

REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

Key Points: 
  • REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.
  • Participants also required a diagnosis that met The International Psychogeriatric Association’s (IPA) provisional definition of agitation in patients with cognitive impairment or dementia.
  • “Agitation associated with dementia due to Alzheimer’s disease can be very challenging and emotionally distressing for patients and family members caring for them.
  • The trial had high rates of patients completing the trial: 86.8% of the brexpiprazole group and 88.9% of the placebo group.

Reviva Pharmaceuticals Announces Presentation of Clinical Pharmacology Studies Data on Brilaroxazine at the ASPET 2023 Annual Meeting

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Lunedì, Maggio 22, 2023
Volunteering, Human, Central nervous system, Metabolism, Schizophrenia, American Society for Pharmacology and Experimental Therapeutics, New Drug Application, PME, NDA, CYP3A, Schizoaffective disorder, SAD, Cmax, Experiment, CNS, Clozapine, CYP3A4, Risperidone, Plasma, Aripiprazole, Animal, DSM-IV codes, Patient, Phenytoin, Itraconazole, Mouse, State, Glucuronic acid, Pharmacology, Lurasidone, Society, Brexpiprazole, Cariprazine, Safety, ASPET, Vaccine, Pharmaceutical industry, Brilaroxazine

CUPERTINO, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), respiratory and metabolic diseases, has presented two posters on promising clinical pharmacology and safety studies data on the novel serotonin-dopamine stabilizer brilaroxazine at the American Society for Pharmacology and Experimental Therapeutics (ASPET) 2023 annual meeting took place in St. Louis, Missouri, USA, May 18-21, 2023. The ASPET posters are available at revivapharma.com/publications. Brilaroxazine is currently in phase 3 clinical trials for schizophrenia and topline data from the pivotal phase 3 is anticipated in mid this year.

Key Points: 
  • Brilaroxazine is currently in phase 3 clinical trials for schizophrenia and topline data from the pivotal phase 3 is anticipated in mid this year.
  • “These data support the concomitant use of brilaroxazine with other medications metabolized by CYP3A4 as most schizophrenia patients take multiple concomitant medications.
  • As part of the required clinical studies for New Drug Application (NDA), the drug-drug interactions between brilaroxazine with a strong CYP3A4 inhibitor (itraconazole) and inducer (phenytoin) were evaluated.
  • Brilaroxazine single dose co-administered with phenytoin at steady-state resulted in decrease of ~33%, 57% and 54% in brilaroxazine Cmax, AUC0-t, and AUC0∞, respectively.

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer's Disease

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Giovedì, Maggio 11, 2023
Myenteric plexus, CMAI, Alzheimer's disease, Somnolence, Center for Drug Evaluation and Research, Deficit spending, Urinary tract infection, Boxed, Fast Track, Brain, Sleep, Agitation, Dementia, Insomnia, Dizziness, HIV disease progression rates, Patient, Division, Risk, Psychiatry, Diagnosis, Mini–Mental State Examination, Research, FDA, Headache, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Caregiver, Pharmaceutical industry, Residential care, Brexpiprazole, Common

"Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer's disease.

Key Points: 
  • "Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer's disease.
  • "These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression."
  • Agitation is among the most persistent, complex, stressful, and costly aspects of care among patients with behavioral and psychological symptoms of dementia.
  • The effectiveness of Rexulti for the treatment of agitation associated with dementia due to Alzheimer's disease was determined through two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies.

Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease

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Giovedì, Maggio 11, 2023
Mental Health, Research, FDA, Neurology, Genetics, Health, Pharmaceutical, General Health, Science, CMAI, Week, New Drug Application, Medication, Agitation, Incidence, Shanda, Dementia, Patient, Inabata & Co., Ltd., Otsuka Pharmaceutical, Diagnosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Brexpiprazole, Food, Caregiver, Safety, Residential care, Lundbeck

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.

Key Points: 
  • Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.
  • This approval makes REXULTI the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease.
  • Agitation is a common neuropsychiatric symptom in Alzheimer’s dementia and one of the most complex and stressful aspects of caring for people living with the condition.
  • Brexpiprazole patients with agitation associated with dementia due to Alzheimer’s disease achieved a 31% greater reduction from baseline in frequency of agitation symptoms vs. placebo.

CRIO Welcomes Dr. Margaretta Nyilas to its Board of Directors

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Giovedì, Novembre 3, 2022
Board, Knowledge, Clinical data management, Bristol Myers Squibb, Clinical trial, Boston Millennia Partners, CEO, Technology, Heart, Aripiprazole, Board of directors, CRIO, Cros, Medicine, Therapy, Norwest Venture Partners, ESourcing Capability Model, Otsuka Pharmaceutical, JD, Margaretta, Brexpiprazole, Pharmaceutical industry

BOSTON, Nov. 3, 2022 /PRNewswire/ --CRIO, the industry's leading eSource provider, announces the appointment of Dr. Margaretta Nyilas to its Board of Directors, effective immediately.

Key Points: 
  • BOSTON, Nov. 3, 2022 /PRNewswire/ --CRIO, the industry's leading eSource provider, announces the appointment of Dr. Margaretta Nyilas to its Board of Directors, effective immediately.
  • She joins CRIO as its first independent director, where she will bring her unique blend of knowledge in clinical operations, technology and medicine.
  • "We couldn't be happier with Margaretta joining the Board," says Raymond Nomizu, JD, CEO and co-founder at CRIO.
  • Dr. Nyilas joins CRIO board members Sankesh Abbhi, formerly CEO of ArisGlobal; Tom Peterson, Venture Partner at Rally Ventures; and CEO, Raymond Nomizu.

Brii Biosciences Appoints Eleanor de Groot as Chief Technology Officer and Aleksandar Skuban as Central Nervous System Diseases Therapy Area Head

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Martedì, Agosto 23, 2022
Alexion, Schizophrenia, MDR, Semmelweis University, COVID-19, The Company, University, XDR, Ophthalmology, Business administration, Research, Central nervous system, Therapy, Rice University, Master of Business Administration, Time, Lists of diseases, Infection, MIT, SVP, CMC, School, Multimedia, Hepatitis B, Alexander, HIV, Health, Company, FDA, Doctor of Philosophy, Biotechnology, Stanford University, Chemical engineering, Merck, University of Novi Sad Faculty of Technical Sciences, Sanofi, Growth, Master of Science, CNS, Anxiety, Temple University School of Medicine, Otsuka Pharmaceutical, Patient, Pharmaceutical industry, Medicine, Medicine, Brexpiprazole, Operation

DURHAM, N.C. and BEIJING, Aug. 22, 2022 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced the appointments of Eleanor (Ellee) de Groot, Ph.D., as Chief Technology Officer and Aleksandar Skuban, M.D., as Central Nervous System (CNS) Diseases Therapy Area Head.

Key Points: 
  • DURHAM, N.C. and BEIJING, Aug. 22, 2022 /PRNewswire/ -- Brii Biosciences Limited("Brii Bio" or the "Company", stock code: 2137.HK), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced the appointments of Eleanor (Ellee) de Groot, Ph.D., as Chief Technology Officer and Aleksandar Skuban, M.D., as Central Nervous System (CNS) Diseases Therapy Area Head.
  • "Ellee and Aleksandar are both seasoned biotech leaders with impressive credentials and an entrepreneurial history of leading medicine development and manufacturing initiatives within their functional areas.
  • Prior to that, he served as an Executive Medical Director leading clinical development within Alexion's emerging ophthalmology therapeutic area.
  • "I am inspired by the meaningful patient-centric approach that Brii Biohas cultivated in the earliest stages of clinical planning.

Otsuka Pharmaceutical and Lundbeck to Present Phase 3 Data for Brexpiprazole in Patients with Alzheimer’s Dementia at AAIC 2022

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Martedì, Agosto 2, 2022
Mental Health, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, AAIC, Neurological disorder, Commercialization, Tuberculosis, Twitter, Doctor of Philosophy, Maintenance, Behavior, OAPI, Medication, Brexpiprazole, Health, Ōtsuka, Neuropsychiatry, Conference, Agitation, Quality of life, Mental health, Creativity, Disease, FDA, Patient, LinkedIn, Neurology, Heart, Cardiology, OAI, Lundbeck, Research and development, Nephrology, Pharmaceutical industry, Instagram

Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S (Lundbeck) today announce that new Phase 3 data for brexpiprazole will be presented at the 2022 Alzheimers Association International Conference (AAIC) , which is being held virtually and in San Diego from July 31 through August 4.

Key Points: 
  • Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S (Lundbeck) today announce that new Phase 3 data for brexpiprazole will be presented at the 2022 Alzheimers Association International Conference (AAIC) , which is being held virtually and in San Diego from July 31 through August 4.
  • Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsukapeople creating new products for better health worldwide.
  • Today, through holdings company, Otsuka America, Inc. (OAI), its affiliates Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI), employ 1,700 U.S. employees.
  • OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.

Otsuka and Lundbeck Announce Decision to Continue Phase III Clinical Trial Evaluating Brexpiprazole for Treatment of Agitation in Patients With Alzheimer's-type Dementia

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Martedì, Aprile 13, 2021
Pharmaceutical, Health, Clinical trials, Serotonin antagonists, Atypical antipsychotics, 5-HT2A antagonists, Otsuka Pharmaceutical, Brexpiprazole, Lundbeck, Dementia, Agitation, the study, brexpiprazole, Otsuka Pharmaceutical, H. Lundbeck A/S

b"Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the decision to continue the recruitment of patients in the phase III clinical trial of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type (NCT03548584).

Key Points: 
  • b"Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the decision to continue the recruitment of patients in the phase III clinical trial of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type (NCT03548584).
  • Completion of the trial is expected in the first half of 2022.\nTrial 331-14-213 (NCT03548584; Trial 213) was designed to assess the safety, tolerability and efficacy of brexpiprazole in the treatment of patients with agitation in Alzheimer\xe2\x80\x99s dementia.
  • Patients participating in the trial are from countries including Bulgaria, Hungary, Serbia, Slovakia, Spain, Ukraine, and the U.S.
  • In Europe, brexpiprazole is distributed and marketed under the brand name Rxulti\xc2\xae.\nBrexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.