Atypical antipsychotics

Lyndra Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for Lyndra’s Weekly Risperidone (LYN-005) for the Treatment of Adults with Schizophrenia and Other Indications

Retrieved on: 
Monday, July 19, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Psychiatry, Drugs, Abnormal psychology, Psychiatric diagnosis, Atypical antipsychotics, Mood stabilizers, Depression, Mood disorders, Risperidone, Bipolar disorder, Schizophrenia, Bipolar I disorder

The company plans to initiate its pivotal program for LYN-005, designed as the first-ever oral, ultra-long-acting, extended-release therapy, in early 2022.

Key Points: 
  • The company plans to initiate its pivotal program for LYN-005, designed as the first-ever oral, ultra-long-acting, extended-release therapy, in early 2022.
  • Both studies will evaluate LYN-005 at weekly doses ranging from 2 to 6 mg risperidone daily.
  • These studies will support indications in schizophrenia, bipolar mania, and bipolar 1 disorder.
  • We are grateful to the FDA for their guidance as we design this pivotal program.

Acadia Pharmaceuticals to Present New Scientific Data on Pimavanserin in Neurodegenerative Diseases at the Alzheimer’s Association International Conference 2021 (AAIC)

Retrieved on: 
Wednesday, July 14, 2021
Medical Supplies, Health, Hospitals, General Health, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Atypical antipsychotics, Piperidines, Pimavanserin, Ureas, Acadia Pharmaceuticals, Chemistry

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimers Association International Conference 2021 (AAIC), being held July 26-30, 2021 in Denver, Colo., and virtually.

Key Points: 
  • Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimers Association International Conference 2021 (AAIC), being held July 26-30, 2021 in Denver, Colo., and virtually.
  • The poster presentations include two analyses of patients who have neurodegenerative disease taking pimavanserin while also receiving other antidementia medication.
  • In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors.
  • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components.

OWP Pharmaceuticals Announces Patent Issuance for the First-Ever Oral Liquid Suspension of Quetiapine for the Treatment of Schizophrenia and Bipolar Disorder

Retrieved on: 
Thursday, July 1, 2021
Psychoactive drugs, Receptor antagonists, Drugs, Atypical antipsychotics, Mood stabilizers, Piperazines, Depression, Mood disorders, Quetiapine, Antipsychotic, Bipolar I disorder, Bipolar II disorder

OWP announced today that the United States Patent and Trademark Office (USPTO) has issued a patent to OWP for the first-ever oral liquid suspension of quetiapine.

Key Points: 
  • OWP announced today that the United States Patent and Trademark Office (USPTO) has issued a patent to OWP for the first-ever oral liquid suspension of quetiapine.
  • Quetiapine is an atypical antipsychotic and the tablets, for oral use, were first approved in the U.S. in 1997.
  • In schizophrenia, quetiapine is indicated for treatment in adolescents aged 13 to 17 years and adults.
  • It is also indicated as monotherapy for the acute treatment of depressive episodes in adult patients with bipolar I and bipolar II disorder.

Lyndra Therapeutics Completes $60.5 Million Series C Financing

Retrieved on: 
Thursday, June 24, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Other Health, Chemical compounds, Organic compounds, Drugs, Prolactin releasers, Atypical antipsychotics, Lactams, Mood stabilizers, Piperidines, Risperidone, Schizophrenia

Lyndra Therapeutics , a clinical-stage biotechnology company pioneering a novel technology platform that transforms daily pills into once-weekly to monthly oral treatment options, today announced the closing of its $60.5 million Series C financing.

Key Points: 
  • Lyndra Therapeutics , a clinical-stage biotechnology company pioneering a novel technology platform that transforms daily pills into once-weekly to monthly oral treatment options, today announced the closing of its $60.5 million Series C financing.
  • View the full release here: https://www.businesswire.com/news/home/20210624005094/en/
    Lyndras ultra-long-acting, extended-release oral capsule dosage form technology is the first of its kind.
  • Our trailblazing lead product candidate is a once-weekly oral risperidone treatment which has the potential to provide a meaningful benefit to the over two million people with schizophrenia, their caregivers and healthcare providers, said Dr. Patricia Hurter, Chief Executive Officer of Lyndra Therapeutics.
  • Lyndra has raised almost $250 million in funding, inclusive of this round.

Starton Therapeutics Phase 2 TROPIC-I Clinical Study will be First to Use Total Control Primary Endpoint in Superiority Study

Retrieved on: 
Wednesday, June 16, 2021
Serotonin antagonists, Receptor antagonists, Drugs, Oncology, Vomiting, Atypical antipsychotics, Chemotherapy-induced nausea and vomiting, Antiemetic, Olanzapine, Nausea, Endpoint, Clinical endpoint

Total Control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a Complete Response (CR) endpoint which only measures vomiting and rescue medications.

Key Points: 
  • Total Control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a Complete Response (CR) endpoint which only measures vomiting and rescue medications.
  • The largest and most comprehensive meta-analysis of the use of olanzapine in CINV was published a few months ago (Chow 2021).
  • The meeting provided guidance for the design of the planned Phase 2 clinical study and endpoint strategy, as well as planned work to support the validation of a nausea scale.
  • Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements.

Acadia Pharmaceuticals, Inc. Investors: Last Days to Participate Actively in the Class Action Lawsuit; Portnoy Law Firm

Retrieved on: 
Monday, June 14, 2021
Organic compounds, Chemical compounds, Atypical antipsychotics, Pimavanserin, Piperidines, Ureas, Portnoy, Food and Drug Administration, Psychosis, Chemistry

Investors are encouraged to contact attorney Lesley F. Portnoy , to determine eligibility to participate in this action, by phone 310-692-8883 or email , or click here to join the case.

Key Points: 
  • Investors are encouraged to contact attorney Lesley F. Portnoy , to determine eligibility to participate in this action, by phone 310-692-8883 or email , or click here to join the case.
  • The complaint alleges that Acadia misrepresented facts concerning their supplemental new drug application for NUPLAZID (pimavanserin), which treats dementia-related psychosis.
  • Thereafter, Acadia repeatedly stated the FDA had not identified any potential review issues, reiterating the efficacy of the drug.
  • The Portnoy Law Firm represents investors in pursuing arising from corporate wrongdoing.

Acadia Pharmaceuticals, Inc. Investors: Last Days to Participate Actively in the Class Action Lawsuit; Portnoy Law Firm

Retrieved on: 
Tuesday, June 8, 2021
Organic compounds, Chemical compounds, Atypical antipsychotics, Pimavanserin, Piperidines, Ureas, Portnoy, Food and Drug Administration, Psychosis, Chemistry

Investors are encouraged to contact attorney Lesley F. Portnoy , to determine eligibility to participate in this action, by phone 310-692-8883 or email , or click here to join the case.

Key Points: 
  • Investors are encouraged to contact attorney Lesley F. Portnoy , to determine eligibility to participate in this action, by phone 310-692-8883 or email , or click here to join the case.
  • The complaint alleges that Acadia misrepresented facts concerning their supplemental new drug application for NUPLAZID (pimavanserin), which treats dementia-related psychosis.
  • Thereafter, Acadia repeatedly stated the FDA had not identified any potential review issues, reiterating the efficacy of the drug.
  • The Portnoy Law Firm represents investors in pursuing arising from corporate wrongdoing.

Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar I Disorder

Retrieved on: 
Tuesday, June 1, 2021
Receptor antagonists, Serotonin antagonists, Drugs, Atypical antipsychotics, Mood stabilizers, Muscarinic antagonists, Piperazines, Olanzapine, Alkermes, Schizophrenia, Olanzapine/samidorphan

"Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.

Key Points: 
  • "Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.
  • "LYBALVI represents an important new treatment option for adults with schizophrenia or bipolar I disorder, their clinicians and caregivers, and reflects Alkermes' commitment to developing new therapies that support patient-centered care," said Richard Pops, Chairman and Chief Executive Officer at Alkermes.
  • The most common adverse events (AEs) for both the LYBALVI and olanzapine treatment groups were weight gain, somnolence and dry mouth.
  • ENLIGHTEN-2 evaluated the weight gain profile of LYBALVI compared to olanzapine over six months in 561 patients with stable schizophrenia.

Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar I Disorder

Retrieved on: 
Tuesday, June 1, 2021
Receptor antagonists, Serotonin antagonists, Drugs, Atypical antipsychotics, Mood stabilizers, Muscarinic antagonists, Piperazines, Olanzapine, Alkermes, Schizophrenia, Olanzapine/samidorphan

"Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.

Key Points: 
  • "Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety.
  • "LYBALVI represents an important new treatment option for adults with schizophrenia or bipolar I disorder, their clinicians and caregivers, and reflects Alkermes' commitment to developing new therapies that support patient-centered care," said Richard Pops, Chairman and Chief Executive Officer at Alkermes.
  • The most common adverse events (AEs) for both the LYBALVI and olanzapine treatment groups were weight gain, somnolence and dry mouth.
  • ENLIGHTEN-2 evaluated the weight gain profile of LYBALVI compared to olanzapine over six months in 561 patients with stable schizophrenia.

BioXcel Therapeutics Announces FDA Acceptance for Filing of NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II

Retrieved on: 
Wednesday, May 19, 2021
Psychiatry, Psychiatric diagnosis, Abnormal psychology, Receptor antagonists, Psychopathology, Cognitive disorders, Atypical antipsychotics, Mood stabilizers, Bipolar disorder, Dementia, Schizophrenia

The FDA has assigned a Prescription Drug User Fee Act (\xe2\x80\x9cPDUFA\xe2\x80\x9d) target action date of January 5, 2022.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (\xe2\x80\x9cPDUFA\xe2\x80\x9d) target action date of January 5, 2022.
  • On average, patients with these conditions experience more than a dozen episodes per year, the majority requiring pharmacologic treatment.
  • BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders and dementia.
  • The Company recently received acceptance of its New Drug Application for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders.