EQS-News: ABVC BioPharma Highlights Safety Profile of Its Plant-Based ADHD Candidate Amid Growing Concerns About Psychiatric Polypharmacy in the United States

SILICON VALLEY, CA - December 2, 2025 (NEWMEDIAWIRE) - ABVC BioPharma, Inc. (“ABVC” or the “Company”) (NASDAQ: ABVC) today addressed recent public discussions surrounding attention-deficit/hyperactivity disorder (ADHD) treatment in the United States[1]. As reports raise concerns regarding the increasing trend of psychiatric “polypharmacy”, the use of multiple psychiatric medications over time, ABVC reaffirmed the differentiated safety-focused approach of its plant-based ADHD drug candidate, ABV-1505, which has demonstrated a favorable tolerability profile in early clinical in-house studies with no drug-related serious adverse events reported to date.

Recently, The Wall Street Journal has also highlighted this growing concern. The WSJ article referenced multiple anecdotal accounts from individuals who began ADHD medication at a young age and ultimately received numerous additional psychiatric drug prescriptions over time[2]. These media-reported stories underscore the public’s increasing awareness of the potential long-term medication burden associated with conventional stimulant therapies and the need for safer therapeutic alternatives.

A recent national conversation, including analyses published by major U.S. media outlets, has drawn attention to an emerging issue: children and adolescents starting with ADHD medications are more likely than the general population to later receive additional psychiatric drug prescriptions[3,4]. This raises important questions about long-term treatment strategies, safety, and the need for alternative therapeutic approaches that minimize downstream medication burden.

The media has been focusing on a theory that children and adolescents who take ADHD medications are more likely than the general population to later receive additional psychiatric drug prescriptions[5].

ABV-1505: A Distinctive, Plant-Based Approach to ADHD

ABVC’s ADHD program centers on ABV-1505, a botanical extract derived from Polygala tenuifolia (??). Unlike traditional stimulant or amphetamine-based therapies, ABV-1505 is:

• Plant-based
• Non-stimulant
• Not shown to cause addiction or dependency
• Not showing drug-related serious adverse events in clinical studies
• Designed to potentially reduce the likelihood of escalating to multi-drug psychiatric regimens

Additionally, ABV-1505 has completed a Phase II clinical trial at the University of California, San Francisco (UCSF), which showed (1) statistically significant improvement on ADHD rating scales compared with placebo, and (2) the treatment was well tolerated, with no serious safety concerns observed.

[1] https://www.wsj.com/tech/personal-tech/when-adhd-meds-are-just-the-start-70a61ca7?gaa_at=eafs&gaa_n=AWEtsqf25a0k3Ln3Vm3POupPh4Q7a8m8BafxZA-G98KKZN-ouwB7jN7x_o4HXKD7hrA%3D&gaa_ts=69255b6a&gaa_sig=XN2yF-kysnSfF2tcjJpBrsSI0xSJk7ylzJe9HyUvHjmJKKLNu9Nx2aqv0RI8F1u9KpX7U3DXQic7ZtNL-fSHSg%3D%3D

[2] https://www.wsj.com/tech/personal-tech/when-adhd-meds-are-just-the-start-70a61ca7

[3] https://edition.cnn.com/2018/07/17/health/adhd-symptoms-digital-media-study/index.html

[4] https://edition.cnn.com/2018/08/31/health/adhd-trends-study-partner/index.html

[5] https://ttmgoal.com/news/2584034809edition=fundamental&utm_source=news&utm_campaign=2584034809&utm_medium=telegram&platform=iOS&shareID=cca4e2980b2810939b6ed8a047658ef0&invite=P2VN3E&lang=en_US

The company is preparing the next phase of clinical development in collaboration with global partners.

Addressing an Unmet Clinical and Social Need

“Growing concerns about long-term psychiatric medication burden highlight the need for safer, non-stimulant, and non-habit-forming ADHD treatment options,” said Dr. Uttam Patil, ABVC's Chief Executive Officer. “Our plant-based candidate ABV-1505 is being developed precisely with this purpose, to explore whether an effective treatment can also offer a cleaner and safer tolerability profile. While more research is required, the clinical findings to date are encouraging.” Mr. Patil further noted that “Many families are searching for therapies that can help manage ADHD symptoms without increasing the risk of additional psychiatric medications later in life. We believe ABV-1505 represents a meaningful step toward expanding the treatment toolbox available to patients and healthcare providers.”

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 pivotal clinical trials (Phase III) through global partnerships.

Forward-Looking Statements

This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential," or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. None of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company's securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company's securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

Contact:

Uttam Patil
Email: uttam@ambrivis.com 

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