ABVC BioPharma Seeks to Revolutionize Mental Health Treatment With a Safe Prozac Alternative, Boasting a MADRS Score Reduction of -13.21
ABVC BioPharma announces its ABV-1504 drug as a potential safer alternative to Prozac, which faces discontinuation due to side effects concerns. The drug's active ingredient, PDC-1421 (derived from Radix Polygala), has shown promising results in treating Major Depressive Disorder (MDD) and ADHD, achieving a MADRS score reduction of -13.21 from baseline over 6 weeks.
The company has completed Phase II clinical trials and is moving towards Phase III trials globally, with patents valid until 2041. The treatment demonstrates fewer adverse effects compared to traditional antidepressants, positioning it strategically in growing markets. The global MDD market is expected to reach $14.96 billion by 2032, while the ADHD treatment market shows a 7.3% CAGR through 2032.
ABVC BioPharma annuncia il suo farmaco ABV-1504 come un'alternativa potenzialmente più sicura a Prozac, che rischia di essere ritirato a causa di preoccupazioni legate agli effetti collaterali. L'ingrediente attivo del farmaco, PDC-1421 (derivato da Radix Polygala), ha mostrato risultati promettenti nel trattamento del Disturbo Depressivo Maggiore (MDD) e dell'ADHD, ottenendo una riduzione del punteggio MADRS di -13,21 rispetto al valore di partenza nel corso di 6 settimane.
L'azienda ha completato la fase II degli studi clinici e si sta preparando per i trial di fase III a livello globale, con brevetti validi fino al 2041. Il trattamento dimostra meno effetti avversi rispetto agli antidepressivi tradizionali, posizionandosi strategicamente in mercati in crescita. Si prevede che il mercato globale del MDD raggiunga i 14,96 miliardi di dollari entro il 2032, mentre il mercato per il trattamento dell'ADHD mostra un CAGR del 7,3% fino al 2032.
ABVC BioPharma anuncia su medicamento ABV-1504 como una alternativa potencialmente más segura al Prozac, que enfrenta la discontinuación debido a preocupaciones sobre sus efectos secundarios. El ingrediente activo del medicamento, PDC-1421 (derivado de Radix Polygala), ha mostrado resultados prometedores en el tratamiento del Trastorno Depresivo Mayor (MDD) y del TDAH, logrando una reducción del puntaje MADRS de -13.21 desde la línea base en un periodo de 6 semanas.
La empresa ha completado los ensayos clínicos de fase II y se está preparando para los ensayos de fase III a nivel global, con patentes válidas hasta 2041. El tratamiento muestra menos efectos adversos en comparación con los antidepresivos tradicionales, posicionándose estratégicamente en mercados en crecimiento. Se espera que el mercado global del MDD alcance los 14.96 mil millones de dólares para 2032, mientras que el mercado de tratamiento del TDAH muestra un CAGR del 7.3% hasta 2032.
ABVC BioPharma는 부작용 우려로 인해 단종될 위기에 처한 프로작의 잠재적으로 더 안전한 대안으로 ABV-1504 약물을 발표했습니다. 이 약물의 활성 성분인 PDC-1421(라디스 폴리가라에서 유래)은 주요 우울 장애(MDD)와 ADHD 치료에서 유망한 결과를 보여주며, 6주 동안 기준선 대비 -13.21의 MADRS 점수 감소를 달성했습니다.
회사는 2상 임상 시험을 완료하고 있으며, 전 세계적으로 3상 임상 시험으로 나아가고 있으며, 특허는 2041년까지 유효합니다. 이 치료법은 전통적인 항우울제보다 부작용이 적어 성장하는 시장에서 전략적으로 자리 잡고 있습니다. 글로벌 MDD 시장은 2032년까지 149억 6천만 달러에 이를 것으로 예상되며, ADHD 치료 시장은 2032년까지 7.3%의 연평균 성장률(CAGR)을 보일 것으로 전망됩니다.
ABVC BioPharma annonce son médicament ABV-1504 comme une alternative potentiellement plus sûre au Prozac, qui est menacé d'arrêt en raison de préoccupations liées aux effets secondaires. L'ingrédient actif du médicament, le PDC-1421 (dérivé du Radix Polygala), a montré des résultats prometteurs dans le traitement du Trouble Dépressif Majeur (MDD) et du TDAH, avec une réduction du score MADRS de -13,21 par rapport à la ligne de base sur 6 semaines.
L'entreprise a terminé les essais cliniques de phase II et se dirige vers des essais de phase III à l'échelle mondiale, avec des brevets valides jusqu'en 2041. Le traitement présente moins d'effets indésirables par rapport aux antidépresseurs traditionnels, se positionnant stratégiquement sur des marchés en croissance. On s'attend à ce que le marché mondial du MDD atteigne 14,96 milliards de dollars d'ici 2032, tandis que le marché du traitement du TDAH affiche un taux de croissance annuel de 7,3 % d'ici 2032.
ABVC BioPharma kündigt sein Medikament ABV-1504 als eine potenziell sicherere Alternative zu Prozac an, das aufgrund von Bedenken bezüglich der Nebenwirkungen eingestellt werden könnte. Der aktive Inhaltsstoff des Medikaments, PDC-1421 (stammt aus Radix Polygala), hat vielversprechende Ergebnisse bei der Behandlung von Major Depressive Disorder (MDD) und ADHS gezeigt und eine Reduzierung des MADRS-Scores um -13,21 im Vergleich zur Ausgangsbasis über einen Zeitraum von 6 Wochen erreicht.
Das Unternehmen hat die Phase-II-Studien abgeschlossen und bereitet sich auf globale Phase-III-Studien vor, wobei die Patente bis 2041 gültig sind. Die Behandlung zeigt im Vergleich zu traditionellen Antidepressiva weniger unerwünschte Wirkungen und positioniert sich strategisch in wachsenden Märkten. Es wird erwartet, dass der globale Markt für MDD bis 2032 14,96 Milliarden US-Dollar erreicht, während der Markt für ADHS-Behandlungen bis 2032 ein jährliches Wachstum von 7,3 % verzeichnet.
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FREMONT, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company focused on innovative treatments in ophthalmology, CNS (central nervous system), and oncology/hematology, today announced in response to the discontinuation of Prozac[1] due to increasing concerns around side effects, ABVC believes its ABV-1504, which has the API, “Radix Polygala”, known as Polygala tenuifolia Willd or PDC-1421, can fill this void in the mental health market. With a robust formulation designed to reduce adverse effects, PDC-1421 promises to offer a safer and more effective solution for patients dealing with MDD and ADHD[2]. ABVC’s ABV-1504 has completed Phase II clinical trials and is heading towards Phase III trials worldwide. ABVC holds patents for MDD and ADHD that have been approved in the USA and other countries and are valid until 2041.
The suspension of Prozac production highlights a rising demand for safer, all-natural alternatives to advanced mental health treatments, marking a pivotal moment for the pharmaceutical and mental health awareness industry. ABVC's ABV-1504 and 1505 have undergone rigorous clinical testing to ensure safety and efficacy, positioning them as real potential options for patients needing reliable, low-risk treatments.
"Our team has dedicated extensive research to developing a treatment that addresses the symptoms of MDD and ADHD and prioritizes patient well-being by reducing the risk of severe side effects," said Uttam Patil, Ph.D., Chief Executive Officer of ABVC. "With Prozac's exit, there's a market need, and we strongly believe that PDC-1421 will help bridge this gap while setting new standards in mental health treatment."
He further added, "PDC-1421 is a novel compound derived from plant sources and has shown promise in treating Major Depressive Disorder (MDD) and Attention Deficit Hyperactivity Disorder (ADHD). In clinical studies, PDC-1421 demonstrated an ability to modulate brain pathways associated with mood regulation and cognitive functions, helping to improve depressive symptoms and enhance focus in patients with ADHD. This therapeutic agent, currently under development, stands out for its favorable safety profile, presenting fewer side effects than many existing antidepressants. As Prozac and other traditional medications face challenges related to adverse effects, PDC-1421 offers a potentially safer and more effective alternative. Based on our internal studies, PDC-1421 has demonstrated significant efficacy in treating Major Depressive Disorder (MDD), achieving a MADRS score reduction of -13.21 from baseline over 6 weeks with a placebo-subtracted difference of -4.1. With a favorable safety profile and fewer adverse side effects than traditional treatments like Prozac, PDC-1421 stands out as a compelling alternative, particularly as Prozac faces production cuts due to safety concerns. This innovative approach offers hope for patients seeking safer, effective options in mental health care."
Driving Growth in Expanding Markets
ABVC BioPharma is strategically positioned in growing markets. The global MDD market is projected to grow from
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About ABVC BioPharma & Its Industry
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The Company's network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials through Phase III.
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Contact:
Dr. Uttam Patil
Email: uttam@ambrivis.com
[1] https://www.taiwan-healthcare.org/en/news-detail?id=0slsbhjf5bw318sj
[2] Side effects, or adverse events, associated with ABV-1504, coming from administration of the trial medicine or examination procedure such as the procedure of taking blood (fainting, pain and/or bruising), may lead to gastrointestinal disorders (abdominal fullness and constipation), nervous system disorders (drowsiness, sleepiness, and oral ulcer). In addition, long-term use may cause miscarriages.
[5] https://straitsresearch.com/report/botanical-drugs-market
FAQ
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