MAXONA Pharmaceuticals is Developing MAX-001 as a Non-Opioid, Non-NSAID Oral Therapy for the Treatment of Acute and Chronic Pain

麦索纳制药公司正在开发MAX-001，作为一种非阿片类、非甾体抗炎药的口服疗法，用于治疗急性和慢性疼痛。

IND Submission Marks Fourth Significant Development Milestone for MAX-001 in 2025

IND申请标志着MAX-001在2025年的第四个重要开发里程碑。

MALVERN, Pa.

马尔文，宾夕法尼亚州

,

，

Aug. 7, 2025

2025年8月7日

/PRNewswire/ -- MAXONA Pharmaceuticals today announced that the company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for the company's lead compound, MAX-001, for the treatment of acute pain. MAX-001 is being developed as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain..

/PRNewswire/ -- MAXONA制药公司今日宣布，该公司已向美国食品药品监督管理局（FDA）提交了其主要化合物MAX-001的新药临床试验（IND）申请，用于治疗急性疼痛。MAX-001正被开发为一种新的分子实体（NME）、非阿片类、非甾体抗炎药（NSAID）的口服疗法，用于治疗急性和慢性疼痛。

'During the past six months, MAXONA has achieved a number of important MAX-001 development milestones,' said

“在过去的六个月内，MAXONA已经实现了多个重要的MAX-001开发里程碑，”表示

Shawn Fatholahi

肖恩·法托拉希

, President & CEO of MAXONA Pharmaceuticals. 'I am extremely proud of the remarkable commitment of the MAXONA team and look forward to initiating our Phase 2 study as soon as FDA clearance is received. With the submission of this IND, we are well positioned to accelerate development of MAX-001 and expand the options for safe and effective non-opioid analgesics available to healthcare practitioners to address the pain management needs of their patients.'.

，MAXONA制药公司的总裁兼首席执行官。“我为MAXONA团队非凡的承诺感到无比自豪，并期待在获得FDA批准后立即启动我们的二期研究。随着这份新药临床试验申请（IND）的提交，我们已经为加速开发MAX-001做好了充分准备，并扩大医疗从业者可使用的安全有效的非阿片类镇痛药物的选择，以满足患者的疼痛管理需求。”

MAXONA Pharmaceuticals is developing MAX-001 as a proprietary optimized extended-release (ER) formulation of nefopam, which has been studied extensively and widely prescribed outside

麦索纳制药公司正在开发MAX-001，这是一种专有的优化缓释（ER）制剂的奈福泮，该药物已在国外进行了广泛研究并被广泛处方。

the United States

美国

as a non-scheduled treatment for moderate to severe acute and chronic pain. MAX-001 is designed specifically to deliver both a rapid onset and extended duration of analgesia.

作为中度至重度急慢性疼痛的非计划治疗。MAX-001 专门设计用于提供快速起效和长时间的镇痛效果。

Earlier this year, MAXONA released Phase 1 clinical trial results

今年早些时候，MAXONA 公布了第一阶段临床试验结果。

that showed

显示了

MAX-001 was well tolerated. There were no reported serious adverse events, early discontinuations due to related adverse events, or severe adverse events. There were no concerning findings or abnormal trends in clinical labs, ECGs, and vital signs.

MAX-001 耐受性良好。没有报告严重的不良事件，没有因相关不良事件导致的提前停药，也没有严重不良事件。在临床实验室、心电图和生命体征方面，没有发现令人担忧的结果或异常趋势。

'We are pleased to achieve our goal of submitting the MAX-001 IND in early Q3 2025,' said

“我们很高兴能够实现2025年第三季度初提交MAX-001 IND的目标，”

Robert Rubens

罗伯特·鲁本斯

, MD, MBA, FAAN, and Clinical Development lead for MAXONA Pharmaceuticals. 'Our IND submission reflects our extensive formulation optimization work, comprehensive IND-enabling pre-clinical studies, and the results of the MAX-001 Phase 1 clinical program that was completed in Q1 2025 and will be published later this year.'.

医学博士、工商管理硕士、美国神经病学学会院士，MAXONA制药公司临床开发负责人。“我们的IND申请反映了我们广泛的配方优化工作、全面的IND支持性临床前研究，以及2025年第一季度完成的MAX-001一期临床项目的结果，并且该项目结果将于今年晚些时候发布。”

About MAX-001

关于MAX-001

MAX-001 is a proprietary optimized extended-release (ER) formulation of nefopam, a non-opioid, non-NSAID analgesic that has been studied extensively and widely prescribed for acute and chronic pain outside

MAX-001 是一种专有的优化缓释 (ER) 制剂，含有非阿片类、非甾体抗炎药 (NSAID) 的奈福泮，该药物已被广泛研究并在国外广泛用于治疗急性和慢性疼痛。

the United States

美国

. MAX-001 is designed specifically to deliver both a rapid onset and extended duration of analgesia exerting its effect primarily through a novel mechanism of action as a triple neurotransmitter re-uptake inhibitor with relative potency greatest for norepinephrine reuptake inhibition, and reuptake inhibition of serotonin greater than dopamine.

MAX-001 专门设计用于通过一种新型作用机制实现快速起效和长时间的镇痛效果，这种机制主要是作为三重神经递质再摄取抑制剂，对去甲肾上腺素再摄取抑制的相对效力最强，对血清素的再摄取抑制强于多巴胺。

When approved for use in the U.S., MAX-001 would be the only triple monoamine re-uptake inhibitor with an indication for the treatment of acute pain..

当在美国获准使用时，MAX-001 将是唯一一种用于治疗急性疼痛的三重单胺再摄取抑制剂。

About MAXONA Pharmaceuticals

关于MAXONA制药公司

MAXONA Pharmaceuticals, headquartered in

总部位于

Malvern, PA

马尔文，宾夕法尼亚州

, is a privately held clinical-stage pharmaceutical company committed to developing the next generation of therapies to help patients maximize life. The company is distinguished by its strong and diversified leadership team with expertise in neuroscience, drug development, drug formulation and delivery technology, clinical trial design and pharmacology to develop patient-centric therapies that are safe, efficacious, clinically proven and trusted by physicians and their patients.

是一家私人持有的临床阶段制药公司，致力于开发下一代疗法，帮助患者最大化生命价值。该公司以其强大而多样化的核心团队而闻名，团队在神经科学、药物研发、药物配方与递送技术、临床试验设计及药理学方面拥有专业知识，旨在开发以患者为中心的安全、有效、经过临床验证且受到医生及其患者信赖的疗法。

The company's initial focus is on advancing MAX-001 as a safe and highly effective non-opioid option for the treatment of acute and chronic pain..

公司最初的重心是将MAX-001作为治疗急慢性疼痛的一种安全且高效的非阿片类替代方案进行开发。

For more information, please visit

欲了解更多信息，请访问

www.maxonapharm.com

www.maxonapharm.com

.

。

Cautionary Statement Regarding Forward Looking Statements

关于前瞻性陈述的谨慎声明

This release may contain 'forward-looking statements'. Forward-looking statements are identified by certain words or phrases such as 'may', 'will', 'aim', 'will likely result', 'believe', 'expect', 'will continue', 'anticipate', 'estimate', 'intend', 'plan', 'contemplate', 'seek to', 'future', 'objective', 'goal', 'project', 'should', 'will pursue' and similar expressions or variations of such expressions.

本发布可能包含“前瞻性声明”。前瞻性声明可以通过某些词语或短语来识别，例如“可能”、“将”、“目标”、“很可能导致”、“相信”、“预期”、“将继续”、“预计”、“估计”、“打算”、“计划”、“考虑”、“寻求”、“未来”、“目的”、“目标”、“项目”、“应该”、“将追求”以及类似表达或这些表达的变化。

These forward-looking statements reflect the company's current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the company.

这些前瞻性陈述反映了公司对其未来计划和业绩的当前预期。这些前瞻性陈述依赖于许多假设和估计，这些假设和估计可能不准确，并且受风险和不确定性的影响。实际结果可能与公司发布的任何前瞻性陈述中预期或表达的结果有重大差异。

The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release..

本公司否认有任何义务或意图更新前瞻性声明，以反映本发布日期之后的事件或情况。

SOURCE Maxona Pharmaceuticals

来源：马科索纳制药公司

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