Risperidone

Lyndra Therapeutics Announces Positive Data from Pivotal Phase 3 Study with Oral Weekly Risperidone (LYN-005) for Schizophrenia

Retrieved on: 
Thursday, January 4, 2024

Lyndra Therapeutics ®, a clinical-stage biopharmaceutical company, today announced positive data from the STARLYNG-1 (LYN-005-C-301) study, comparing the pharmacokinetic (PK) profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily to adults living with schizophrenia and schizoaffective disorder.

Key Points: 
  • Lyndra Therapeutics ®, a clinical-stage biopharmaceutical company, today announced positive data from the STARLYNG-1 (LYN-005-C-301) study, comparing the pharmacokinetic (PK) profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily to adults living with schizophrenia and schizoaffective disorder.
  • The pivotal study included participants with schizophrenia and schizoaffective disorder who were on a stable dose of an oral antipsychotic medication at the start of the study.
  • The study assessed oral weekly risperidone 15 mg and 45 mg, equivalent to 2 mg and 6 mg daily Risperdal, respectively.
  • “We are eager to bring long-acting oral therapies to patients and are focused on advancing oral weekly risperidone into its remaining pivotal safety trial in 2024.”

Lyndra Therapeutics Raises $101 Million in Series E Funding

Retrieved on: 
Thursday, December 21, 2023

Lyndra Therapeutics®, a clinical-stage biopharmaceutical company, today announced the closing of a $101 million Series E financing round.

Key Points: 
  • Lyndra Therapeutics®, a clinical-stage biopharmaceutical company, today announced the closing of a $101 million Series E financing round.
  • Lyndra’s investigational therapies are enabled by the company’s LYNX® drug delivery platform, which creates long-acting oral medicines that can be taken once weekly.
  • The platform originated from the Bob Langer and Gio Traverso Laboratories at MIT, with which Lyndra has an exclusive technology license.
  • The round follows a $20.3 million Series D financing led by Polaris Partners that was completed in June 2023.

Schizoaffective Disorder Drug Pipeline Research Report 2023 Featuring Lyndra Therapeutics, Luye Pharma Group, BioXcel Therapeutics, & Reviva Pharma - ResearchAndMarkets.com

Retrieved on: 
Thursday, November 9, 2023

The "Schizoaffective Disorder - Pipeline Insight, 2023" report offers comprehensive insights into the Schizoaffective disorder pipeline landscape, encompassing information on more than 4 companies and over 4 pipeline drugs.

Key Points: 
  • The "Schizoaffective Disorder - Pipeline Insight, 2023" report offers comprehensive insights into the Schizoaffective disorder pipeline landscape, encompassing information on more than 4 companies and over 4 pipeline drugs.
  • The report delivers a thorough understanding of the current scenario and growth prospects within the Schizoaffective disorder indication.
  • It furnishes an extensive overview of the Schizoaffective disorder pipeline landscape, including information on the disease itself and treatment guidelines.
  • The assessment section of the report includes a comprehensive commercial assessment of Schizoaffective disorder, as well as a clinical evaluation of the pipeline products currently in development.

Gedeon Richter: an effective treatment for female schizophrenia patients

Retrieved on: 
Wednesday, October 18, 2023

Cariprazine was found to be effective in women with schizophrenia in a real-life setting with around 70% of the physicians being satisfied with the results.

Key Points: 
  • Cariprazine was found to be effective in women with schizophrenia in a real-life setting with around 70% of the physicians being satisfied with the results.
  • Schizophrenia is a chronic psychiatric disorder characterized by positive, negative, cognitive, and mood symptoms, affecting about 1% of the population.
  • Although antipsychotics are effective in the treatment of positive symptoms, the management of negative, cognitive, and affective symptoms often remains challenging.
  • Treatment with risperidone is still one of the most used standards when it comes to schizophrenia.

Teva to Present Data for AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023

Retrieved on: 
Wednesday, September 6, 2023

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN.
  • Abstracts include data for AUSTEDO, once-daily AUSTEDO XR, UZEDY, TV-44749 and AJOVY.
  • Once-daily AUSTEDO XR, a new formulation of twice-daily AUSTEDO was approved by the U.S. Food and Drug administration (FDA) in February 2023 for adults with TD and chorea associated with Huntington’s disease (HD), and UZEDY, a long-acting formulation of risperidone for subcutaneous use, was approved by the FDA in April 2023 for adults with schizophrenia.1,2 TV-44749 is an investigational formulation of olanzapine currently being studied in adults with schizophrenia.3
    “Because of the immense impact that mental health and neurological conditions like schizophrenia, TD and HD pose for patients, we are constantly striving to advance research that can enhance available treatment options,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
  • “Following this year’s FDA approval of once-daily AUSTEDO XR and UZEDY and the excitement they have received from the medical community, we are thrilled to continue to share research showcasing their potential for patients living with these debilitating conditions.”
    In addition to these data presentations, Teva will also be hosting a symposium to discuss results of the DECIDE study, highlighting perspectives from U.S. psychiatric clinicians on selecting and initiating LAI antipsychotics as well as the real-world barriers that cause LAIs to remain underutilized in clinical practice.

Acorda Therapeutics Announces Launch of New INBRIJA® Campaign: “For The Fighters™”

Retrieved on: 
Wednesday, August 2, 2023

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has launched a new INBRIJA (levodopa inhalation powder) website and brand campaign.

Key Points: 
  • Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has launched a new INBRIJA (levodopa inhalation powder) website and brand campaign.
  • INBRIJA is not to be used by people who have taken a nonselective monoamine oxidase inhibitor, such as phenelzine or tranylcypromine, within the last 2 weeks.
  • I’m determined to make every day, every moment, count, and to live a full life with my family and friends.
  • The most common side effects of INBRIJA are cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.

Lyndra Therapeutics Announces Leadership Changes, Update on Pivotal Trial Progress

Retrieved on: 
Monday, July 17, 2023

The company also shared that enrollment in the pivotal clinical trial of its lead asset oral weekly risperidone (LYN-005) is on track for an initial data readout in the second half of 2023.

Key Points: 
  • The company also shared that enrollment in the pivotal clinical trial of its lead asset oral weekly risperidone (LYN-005) is on track for an initial data readout in the second half of 2023.
  • Under the leadership of CEO Dr. Patricia Hurter, Lyndra finalized the design of its LYNX™ drug delivery platform.
  • The company also designed and built a high-tech GMP manufacturing facility to produce the LYNX platform and initiated pivotal study of its lead asset oral weekly risperidone (LYN-005).
  • Ballinger joined Lyndra in 2016, was promoted to Chief Operations Officer in 2018 and added the role of President in 2021.

Lyndra Therapeutics Presents Data on Long-Acting Oral Weekly Risperidone (LYN-005) at American Society of Clinical Psychopharmacology 2023 Annual Conference

Retrieved on: 
Wednesday, May 31, 2023

Additionally:

Key Points: 
  • Additionally:
    The simulated minimum steady-state blood plasma concentration of risperidone for people taking oral weekly risperidone (LYN-005) doses of 15, 30, and 45 mg maintained effective concentrations.
  • No apparent trend was observed between simulated average steady-state blood plasma concentrations with oral weekly risperidone and symptoms as measured by PANSS score.
  • Lyndra’s long-acting oral weekly risperidone is designed to enable a week-long dose of risperidone to be delivered in a single oral capsule.
  • Currently, the only long-acting medicines available for schizophrenia require injections, and data show that they are used by a minority of patients.

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

Retrieved on: 
Monday, May 22, 2023

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.

Teva to Present Data Demonstrating UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolonged Time to Impending Relapse for Adults with Schizophrenia at the American Psychiatric Association’s 2023 Annual Meeting

Retrieved on: 
Saturday, May 20, 2023

Abstracts include data for UZEDY (risperidone) extended-release injectable suspension for subcutaneous use, which was recently approved by the FDA for the treatment of schizophrenia in adults.

Key Points: 
  • Abstracts include data for UZEDY (risperidone) extended-release injectable suspension for subcutaneous use, which was recently approved by the FDA for the treatment of schizophrenia in adults.
  • Additional abstracts being presented include data on characteristics that impact TD diagnosis and machine-learning to identify unique patient segments for TD.
  • UZEDY utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell, that controls the rate and duration of risperidone release.
  • This year’s annual APA meeting is being offered both in person and virtually.