ABVC BioPharma Seeks to Revolutionize Mental Health Treatment With a Safe Prozac Alternative

ABVC BioPharma, Inc. recently announced in response to the discontinuation of Prozac 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. ABVC’s ABV-1504 has completed Phase II clinical trials and is heading toward Phase 3 trials worldwide. ABVC holds patents for MDD and ADHD that have been approved in the US 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, PhD, 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. 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.”

ABVC BioPharma is strategically positioned in growing markets. The global MDD market is projected to grow from $11.51 billion in 2022 to $14.96 billion by 2032, with a steady CAGR of 2.8%. The global ADHD treatment market is also growing, expected to increase from $15.23 billion in 2022 at a CAGR of 7.3% through 2032. Additionally, the global botanical drug market, valued at $163 million in 2021, is forecasted to experience an impressive CAGR of 39% through 2030, reaching $3.2 billion.

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 3.