Psych

Teva Presents First Real-World Data from the IMPACT-TD Registry Study at Psych Congress Elevate 2024

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星期六, 六月 1, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, MD, Benzatropine, Teva Pharmaceuticals, Patient, Medication, Embarrassment, Movement, Patient satisfaction, Abnormality (behavior), Life, Teva, TEVA, Doctor of Philosophy, Quality of life, Psychiatry, Severity, Psych, AIMS, University, Congress, Exercise, Nursing

These interim findings from the IMPACT-TD study were presented at the 2024 Psych Congress Elevate Annual Meeting, taking place from May 30 – June 2 in Las Vegas, Nevada.

Key Points: 
  • These interim findings from the IMPACT-TD study were presented at the 2024 Psych Congress Elevate Annual Meeting, taking place from May 30 – June 2 in Las Vegas, Nevada.
  • “TD can be a devastating setback for those who have achieved mental stability with their psychiatric medication,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
  • “These interim findings from IMPACT-TD Registry, the largest study of its kind, reveal the profound effect that TD can have on a patient’s life, beyond the clinic.
  • Final results from the TD cohort of the Phase 4 START study, which investigated real-world treatment outcomes for patients starting AUSTEDO with the 4-week Titration Kit.

New Data Provide Schizophrenia Treatment Insights into Switching to UZEDY® (risperidone) Extended-Release Injectable Suspension from Invega Sustenna® (paliperidone palmitate)

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星期六, 六月 1, 2024
Mental Health, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MD, Safety, Teva Pharmaceuticals, Patient, Interview, Young adult, Comparable, Medication, Health professional, SHINE, Lais, De novo, HCP, Teva, TEVA, Doctor of Philosophy, Risk, Multinational, Psychiatry, Psych, Death, FDA, Paliperidone palmitate, Congress, Initial, Ageing, Pharmaceutical industry

Presentations include data informing clinical strategies for switching patients to UZEDY, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, from a once-monthly intramuscular injection of Invega Sustenna.

Key Points: 
  • Presentations include data informing clinical strategies for switching patients to UZEDY, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, from a once-monthly intramuscular injection of Invega Sustenna.
  • 1
    In the patient and caregiver surveys, 20 patients and 19 caregivers completed a 60-minute interview regarding the use of LAIs in schizophrenia.
  • 1
    Below is the full set of UZEDY and long-acting injectable data presented by Teva at Psych Congress Elevate 2024.
  • UZEDY is not approved for use in patients with dementia-related psychosis and has not been studied in this patient population.

FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD

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星期二, 五月 21, 2024
Patient, Food, NDA, Cingulata, FDA, Congress, Psychiatry, Clutch (eggs), Attention deficit hyperactivity disorder, Psych, File, Poster, Communication, ADHD, Pharmaceutical industry

KANSAS CITY, Kan., May 21, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced that it has received confirmation from and is aligned with the U.S. Food and Drug Administration (FDA) on the requirements necessary for filing a New Drug Application (NDA) for its lead Phase 3 candidate CTx-1301 (dexmethylphenidate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age or older.

Key Points: 
  • “We are pleased with the FDA’s guidance and perspective regarding our pathway to a timely NDA filing, and we will proceed to complete all remaining requirements accordingly,” said Cingulate Chairman and CEO Shane J. Schaffer.
  • Many patients require longer duration of efficacy and must add a second, or booster, dose to ensure treatment effect over their entire active day.
  • The Cingulate poster presented at APSARD provided additional insight regarding CTx-1301’s ADHD leading effect size.
  • Effect size conveys clinical significance rather than statistical significance, is not reliant on sample size, and allows for comparison across trials.

Castle Biosciences’ IDgenetix® Test Receives 2024 MedTech Breakthrough Award for “Best Overall Mental Health Solution”

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星期五, 五月 10, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Biometrics, Oncology, Mental Health, Health Technology, Other Science, Genetics, Science, Patient, DNA, GEP, Education, Clifford Whittingham Beers, Artificial intelligence, Life, Mental health, Biomarker, Psych, DSM-IV codes, Medtech, Arm, Esophagus, MHA

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has been selected as the winner of the “Best Overall Mental Health Solution” award in the eighth annual MedTech Breakthrough Awards program for its IDgenetix® pharmacogenomic (PGx) test.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has been selected as the winner of the “Best Overall Mental Health Solution” award in the eighth annual MedTech Breakthrough Awards program for its IDgenetix® pharmacogenomic (PGx) test.
  • “Nearly half of all Americans will meet the criteria to be diagnosed with a mental health condition at some point during their life,”1 said Derek Maetzold, president and chief executive officer of Castle Biosciences.
  • Castle is proud to be a platinum sponsor of MHA in 2024, which marks the 75th year since the organization launched Mental Health Week, which later evolved into Mental Health Month.
  • IDgenetix is Castle Biosciences' advanced precision medicine test that offers clinicians an objective way to choose or modify neuropsychiatric medication for their patients with mental health conditions.

Cingulate Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update

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星期一, 四月 1, 2024
Research, ADHD, Psych, NDA, Sale, Cingulata, Attention deficit hyperactivity disorder, Insurance, IND, Market, Adolescence, Safety, Clutch (eggs), Poster, WFIA, FDA, Security (finance)

KANSAS CITY, Kan., April 01, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the twelve months ended December 31, 2023, and provided a clinical and business update. Highlights include capital raised from multiple sources and the addition of three independent board members.

Key Points: 
  • “Our lead asset CTx-1301 continues to impress clinical investigators and key opinion leaders as we share our Phase 3 results.
  • These tailwinds put Cingulate in a position to obtain non-dilutive capital and expand our pipeline of assets.
  • Looking ahead, Cingulate has several financial instruments in place to raise additional capital while fighting to preserve shareholder’s equity.
  • “Overall, I am very pleased with the progress made by our team in 2023 and into 2024.

Cingulate Inc. Reports Third Quarter 2023 Financial Results and Provides Clinical and Business Update

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星期一, 十一月 13, 2023
WFIA, Safety, Exercise, Psych, Patient, ADHD, Series, Cingulata, Dietary supplement, Security (finance), Adult, AISRS

KANSAS CITY, Kan., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) (Cingulate or the Company), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the quarter ended September 30, 2023, as well as a clinical and business update.

Key Points: 
  • If results from this study are successful, pivotal Phase 3 clinical trials in all patient segments for CTx-1302 are expected to begin in 2025.
  • Cash Position: As of September 30, 2023, Cingulate had $2.0 million in cash and cash equivalents.
  • Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and operating expenditures through mid-November 2023.
  • Net loss was $16.6 million for the nine months ended September 30, 2023, compared to $13.0 million for the same period in 2022.

Supernus Announces Third Quarter 2023 Financial Results

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星期三, 十一月 8, 2023
Adjustment, Topiramate, FDA, MADRS, New Drug Application, IND, PD, PDUFA, MDD, DSM-IV codes, Investigational New Drug, Research and development, GAAP, CNS, R, Phase, Prescription, Parkinson's disease, Depreciation, APOKYN, NDA, Safety, Psych, Patient, IQVIA, ADHD, Central nervous system, Attention deficit hyperactivity disorder predominantly inattentive, Video game, Medical device, Pharmaceutical industry, Cryptocurrency, Viloxazine

Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022

Key Points: 
  • Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022
    Qelbree® net product sales of $37.1 million in the third quarter of 2023, a 103% increase compared to the third quarter of 2022 and a 20% increase compared to the second quarter of 2023
    GOCOVRI® net product sales of $32.9 million in the third quarter of 2023, an 18% increase compared to the third quarter of 2022 and a 14% increase compared to the second quarter of 2023
    Operating earnings (GAAP) of $8.1 million in the third quarter of 2023, compared to an operating loss (GAAP) of ($1.5) million in the third quarter of 2022
    Adjusted operating earnings (non-GAAP) of $37.3 million in the third quarter of 2023, an increase of 47% compared to the third quarter of 2022
    SPN-830 (apomorphine infusion device) NDA resubmission accepted for review by FDA; PDUFA date of April 5, 2024
    ROCKVILLE, Md., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the third quarter of 2023, and associated Company developments.
  • “Our third-quarter performance underscores the strength of our growth products, with combined Qelbree and GOCOVRI net product sales increasing 52% in the third quarter of 2023 compared to the same period last year,” said Jack Khattar, President and CEO of Supernus.
  • Qelbree continues to expand its base of prescribers, with approximately 24,189 prescribers in the third quarter of 2023, up from 21,291 prescribers in the second quarter of 2023.
  • A reconciliation of the full year 2023 financial guidance for Operating Loss (GAAP) to Adjusted Operating Earnings (non-GAAP) is included under the heading “Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments.”
    The Company hosted a successful Research & Development (R&D) Day in October 2023 highlighting clinical and R&D progress and its emerging pipeline of novel CNS product candidates.

FHU Hosts "One More Light" Event to Highlight Suicide Prevention

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星期二, 十月 3, 2023
Psych, Student, Life, Education, Suicide, Hope, Leighann Lord, Multimedia, Social work, Grief, FHU, Behavioural sciences, University counseling center, Freed–Hardeman University, One More Light, Nursing, Management

HENDERSON, Tenn., Oct. 3, 2023 /PRNewswire-PRWeb/ -- During a month recognized for promoting suicide prevention awareness, Freed-Hardeman University students, along with members of the Henderson/Chester County community, gathered to "shine light" on an issue that has impacted many.

Key Points: 
  • On Sept. 18, the FHU Department of Behavioral Sciences and the University Counseling Center banded together to bring attention to suicide prevention and mental wellness by organizing an event entitled "One More Light," marking the second time the FHU community has come together for this purpose.
  • Junior social work major Makenna Minor, one of the student organizers of the event, said, "Students seem to want to talk about it.
  • This free event included brief messages by organizers, a song by the FHU Chorale, personal reflections, prayers and honest conversations about a difficult topic.
  • "[The event] opened my eyes a lot to those who struggle with [suicide] or have been indirectly affected by it," FHU senior psychology major LeighAnn Dugger said.

Cingulate Announces Detailed Trial Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD

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星期一, 九月 11, 2023
Psych, Cingulata, ADHD, Meta-analysis, Hour, Congress, Plasma, Insomnia, Attention deficit hyperactivity disorder predominantly inattentive, Scores, Patient, Physician, Behavioral medicine, Psychiatry, Adolescence, FDA, Recurrence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Precision Time Protocol Industry Profile, Food, Safety, Medical imaging, Pharmaceutical industry, Dietary supplement

KANSAS CITY, Kan., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced full results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of attention deficit/hyperactivity disorder (ADHD), presented on September 8th at the 36th Annual Psych Congress, in Nashville, TN. A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.

Key Points: 
  • A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.
  • The Phase 3 CTx-1301-022 study ( NCT05631626 ) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting.
  • “Along with a restricted duration of efficacy, another limitation of current stimulant-based treatments for ADHD is the phenomena of crash and rebound they produce.
  • Additionally, CTx-1301 demonstrated a reduction in Adult ADHD Investigator Symptom Rating Scale (AISRS) scores (-16.3).

Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms

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星期日, 九月 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).