Axsome Therapeutics Initiates PARADIGM Phase 3 Trial of Solriamfetol for the Treatment of Major Depressive Disorder
Axsome Therapeutics, Inc. (NASDAQ: AXSM) initiates Phase 3 trial for solriamfetol in major depressive disorder, dosing the first patient. The PARADIGM trial aims to evaluate efficacy and safety in 300 patients over 6 weeks.
Initiation of a Phase 3 clinical trial represents a significant milestone for Axsome Therapeutics, particularly as it concerns a central nervous system disorder like major depressive disorder (MDD). The substance in question, solriamfetol, is being evaluated for its potential to modulate neurotransmitters that are often implicated in MDD, such as dopamine and norepinephrine. The Montgomery Åsberg Depression Rating Scale (MADRS), a well-established clinical tool, will serve as the primary measure of efficacy. A positive outcome could mean a new therapeutic option for MDD patients, which is a substantial market.
The trial's design, a randomized, double-blind, placebo-controlled setup, is the gold standard for determining drug efficacy and safety. Should solriamfetol demonstrate a significant change in MADRS scores compared to placebo, it could indicate a strong potential for regulatory approval and commercial success. However, the road to approval is long and uncertain and investors should be aware of the risks inherent in drug development, including potential safety issues, regulatory hurdles and the chance of trial failure.
From a financial perspective, the advancement of solriamfetol into Phase 3 trials is likely to be viewed positively by the market, as it reflects progress in Axsome's pipeline. The costs associated with this stage of development are substantial and the company's ability to manage these expenses will be important in maintaining investor confidence. Furthermore, the potential market size for MDD treatments is significant, which could lead to substantial revenue streams if solriamfetol is approved and successfully commercialized.
Investors should monitor enrollment numbers and trial progress, as delays can impact costs and anticipated timelines for potential market entry. It's also important to consider the competitive landscape, with several other treatments for MDD already available or in development. The differentiation of solriamfetol's mechanism of action and its efficacy and safety profile will be key factors in its potential market penetration and impact on Axsome's stock performance.
The pharmacological profile of solriamfetol, targeting the TAAR-1 receptor as well as impacting dopamine and norepinephrine levels, is of particular interest. These neurotransmitters play a significant role in mood regulation and drugs that modulate their activity can offer therapeutic benefits for MDD. Understanding the nuances of solriamfetol's action could provide insights into its potential side effects and long-term safety, which are critical considerations for both clinicians and patients.
Given that MDD is often a chronic condition requiring long-term management, the safety profile of solriamfetol, if approved, will be a key determinant of its success in the market. Additionally, the drug's impact on cognitive function, a common challenge in MDD, will be an important factor in its overall value proposition. As the trial progresses, data on these aspects will be important for assessing the drug's potential.
03/19/2024 - 07:00 AM
NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of MDD in adults. Approximately 300 patients will be randomized in a 1:1 ratio to receive solriamfetol (300 mg) or placebo for 6 weeks. The primary endpoint will be change in the Montgomery Åsberg Depression Rating Scale (MADRS).
About Major Depressive Disorder
Major depressive disorder (MDD) is a debilitating, chronic, biologically based disorder characterized by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms, and which impairs social, occupational, educational, or other important functioning. In severe cases, MDD can result in suicide. According to the National Institutes of Health, an estimated 8.3% of U.S. adults, or approximately 21 million, experience MDD each year1 . According to the World Health Organization (WHO), depression is the leading cause of disability worldwide, and is a major contributor to the overall global burden of disease2 . Nearly two-thirds of diagnosed and treated patients do not experience adequate treatment response with currently available first-line therapy3 , highlighting the need for additional therapies with new mechanisms of action.
About Solriamfetol
Solriamfetol is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. Solriamfetol is not approved by the FDA for the treatment of major depressive disorder.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
Axsome Contacts:
Investors:nd Floormjacobson@axsome.com www.axsome.com
Media:
Darren Oplandnd Floordopland@axsome.com www.axsome.com
Media:
U.S. Department of Health and Human Services. Key Substance Use and Mental Health Indicators in the United States: Results from the 2020 National Survey on Drug Use and Health. Published October 2021. Baune BT, et al. Neuropsychiatr Dis Treat 2021;17:2995-3006. Wardenaar KJ, et al. J. Affect. Disord 2012; 136:1198-1203.
What is the Phase of the trial announced by Axsome Therapeutics for solriamfetol in major depressive disorder?
Axsome Therapeutics announced the initiation of the Phase 3 trial for solriamfetol in major depressive disorder.
What is the primary endpoint of the PARADIGM trial for solriamfetol in major depressive disorder?
The primary endpoint of the PARADIGM trial is the change in the Montgomery Åsberg Depression Rating Scale (MADRS).
How many patients will be randomized in the PARADIGM trial for solriamfetol in major depressive disorder?
Approximately 300 patients will be randomized in a 1:1 ratio to receive solriamfetol (300 mg) or placebo for 6 weeks in the PARADIGM trial.
What is the dosage of solriamfetol being administered in the PARADIGM trial for major depressive disorder?
Patients will receive solriamfetol at a dosage of 300 mg in the PARADIGM trial for major depressive disorder.
What is the full form of the PARADIGM trial in the context of solriamfetol for major depressive disorder?
PARADIGM stands for Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol.
