Nutriband为主要产品提供临床和监管途径概述-AVERSA（R）芬太尼透皮贴剂-动脉网

Nutriband Provides Clinical and Regulatory Path Overview for Lead Product - AVERSA(R) Fentanyl Transdermal Patch

BioSpace 等信源发布 2024-03-27 18:18

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NDA will be primarily based on a single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed prior to submission.

NDA将主要基于单一的1期人类滥用潜在临床研究，在提交之前不需要进行2期或3期临床试验。

AVERSA™ Fentanyl incorporates Nutriband's Aversa™ abuse-deterrent technology with an FDA-approved fentanyl patch and is being developed via a limited 505(b)(2) New Drug Application (NDA) pathway.

AVERSA™芬太尼将Nutriband的AVERSA™滥用威慑技术与FDA批准的芬太尼贴剂相结合，并正在通过有限的505（b）（2）新药申请（NDA）途径开发。

ORLANDO, FL / ACCESSWIRE / March 27, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today provided an overview of the clinical development and regulatory pathway for its lead product, AVERSA™ Fentanyl, an abuse-deterrent fentanyl transdermal patch..

佛罗里达州奥兰多/ACCESSWIRE/2024年3月27日/Nutriband Inc.（纳斯达克：NTRB）（纳斯达克：NTRBW），一家从事处方透皮药品开发的公司，今天概述了其主要产品AVERSA™芬太尼的临床开发和监管途径，AVERSA™芬太尼是一种防止滥用的芬太尼透皮贴剂。。

Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband's AVERSA™ abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system. As Nutriband's abuse-deterrent technology is incorporated into the fentanyl patch but is physically separate and does not come in contact with the drug layer, the clinical trials typically needed to demonstrate safety and efficacy for a new drug formulation are not required..

Nutriband与全球领先的合同开发和制造组织Kindeva Drug Delivery合作，将Nutriband的AVERSA™防滥用透皮技术纳入Kindeva的FDA批准的芬太尼透皮贴剂系统。由于Nutriband的防滥用技术被纳入芬太尼贴剂中，但在物理上是分开的，并且不与药物层接触，因此不需要进行通常需要证明新药制剂安全性和有效性的临床试验。。

Nutriband plans to utilize the 505(b)(2) New Drug Application (NDA) regulatory pathway which limits the development required for products that contain drugs that have already been approved, and allows applicants to reference data already on file at the FDA. As a result, the NDA application will be primarily based on a single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed.

Nutriband计划利用505（b）（2）新药申请（NDA）监管途径，该途径限制了含有已获批准药物的产品所需的开发，并允许申请人参考FDA已经存档的数据。因此，NDA申请将主要基于单一的1期人类滥用潜在临床研究，不需要2期或3期临床试验。

A clinical abuse potential study is typically performed in recreational drug abusers and is designed to demonstrate that the abuse-deterrent product is less preferable to recreational drug abusers than conventional fentanyl patches which contain no abuse-deterrent technology..

临床滥用潜力研究通常在娱乐性药物滥用者中进行，旨在证明与不含滥用威慑技术的常规芬太尼贴剂相比，滥用威慑产品比娱乐性药物滥用者更不可取。。

Following a successful Phase 1 clinical abuse potential study, Nutriband intends to file a 505(b)(2) NDA to the FDA for marketing approval of AVERSA™ Fentanyl, which has the potential to be the first and only abuse deterrent patch approved anywhere in the world. The AVERSA™ Fentanyl NDA has the potential to receive an expedited review by FDA as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs..

在一项成功的第一阶段临床滥用潜力研究之后，Nutriband打算向FDA提交505（b）（2）NDA，以获得AVERSA™芬太尼的上市批准，这有可能成为世界上第一个也是唯一一个被批准的滥用威慑贴剂。AVERSA™芬太尼NDA有可能接受FDA对某些阻止滥用的口服阿片类药物产品的快速审查，这将监管审查期从传统的10个月FDA NDA审查周期缩短到6个月。。

Combined, the clinical development and regulatory path for AVERSA™ Fentanyl is substantially limited compared to conventional pharmaceutical product development, requiring only a single clinical trial and, following a limited NDA pathway, undergoing an expedited review by the FDA.

综上所述，与传统的药品开发相比，AVERSA™芬太尼的临床开发和监管路径受到很大限制，只需要一次临床试验，并且遵循有限的NDA途径，接受FDA的快速审查。

AVERSA™ Fentanyl is estimated to have the potential to reach peak annual US sales of $80 million to $200 million, according to a market analysis report from Health Advances1. The global opioid market was valued at $22.8 billion in 2022.

根据Health Advances1的市场分析报告，据估计，AVERSA™芬太尼在美国的年销售额可能达到8000万至2亿美元的峰值。2022年，全球类阿片市场价值228亿美元。

Nutriband is developing its proprietary AVERSA™ abuse deterrent transdermal technology to be incorporated into any transdermal patch that contains a drug with a risk of abuse, misuse, or accidental exposure. The Company's AVERSA™ product development pipeline includes abuse deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate which are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure..

Nutriband正在开发其专有的AVERSA™防滥用透皮技术，将其纳入任何含有滥用，误用或意外暴露风险的药物的透皮贴剂中。该公司的AVERSA™产品开发渠道包括目前批准和销售的含有芬太尼、丁丙诺啡和哌醋甲酯的透皮贴剂的滥用威慑版本，贴有FDA要求的滥用和误用风险警告，以及意外接触警告。。

1 Health Advances Aversa Fentanyl market analysis report 2022

1 Health Advances Aversa芬太尼2022年市场分析报告

About AVERSA™ Abuse-Deterrent Transdermal Technology

关于AVERSA™防虐待透皮技术

Nutriband's AVERSA™ abuse-deterrent transdermal technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them.

Nutriband的AVERSA™防滥用透皮技术可用于将厌恶剂掺入透皮贴剂中，以防止滥用、转移、误用和意外暴露具有滥用潜力的药物。AVERSA™防滥用技术有可能改善易受滥用的透皮药物（如芬太尼）的安全性，同时确保真正需要这些药物的患者仍然可以使用这些药物。

The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia..

该技术拥有广泛的知识产权组合，并在美国、欧洲、日本、韩国、俄罗斯、加拿大、墨西哥和澳大利亚获得了专利。。

About Nutriband Inc.

关于Nutriband股份有限公司。

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential..

我们主要从事透皮药品组合的开发。我们正在开发的主导产品是一种滥用威慑芬太尼贴剂，它结合了我们的AVERSA™滥用威慑技术。AVERSA™技术可以整合到任何透皮贴剂中，以防止滥用、误用、转移和意外暴露具有滥用潜力的药物。。

The Company's website is www.nutriband.com. Any material contained in or derived from the Company's websites or any other website is not part of this press release.

公司网站为www.nutriband.com。公司网站或任何其他网站中包含或衍生的任何材料均不属于本新闻稿的一部分。

Forward-Looking Statements

前瞻性声明

Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes,' 'anticipates,' 'expects' and words of similar import, constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties.

本新闻稿中包含的某些声明，包括但不限于包含“相信”、“预期”、“期望”和类似含义的声明，构成1995年《私人证券诉讼改革法》含义内的“前瞻性声明”。此类前瞻性陈述涉及已知和未知的风险和不确定性。

The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's Form S-1, Form 10-K for the year ended January 31, 2023, filed April 26, 2023, the Forms 10-Q's filed .

由于多种因素的影响，公司的实际结果可能与前瞻性声明中预期的结果存在重大差异，包括公司开发拟议的滥用威慑芬太尼透皮系统和其他拟议产品的能力，获得滥用技术专利保护的能力，获得开发产品和进行必要临床测试所需资金的能力，获得联邦食品和药物管理局批准在美国销售其可能开发的任何产品的能力，以及获得在其他国家（包括欧洲国家）销售任何产品所需的任何其他监管批准的能力，销售其可能开发的任何产品的能力，创造、维持、管理或预测其增长的能力；吸引和留住关键人员的能力；公司经营战略或发展计划的变更；竞争；业务中断；与资本不足的发展中公司有关的不利宣传以及国际、国家和地方一般经济和市场状况和风险，以及公司表s-1、表10-K（截至2023年1月31日的年度）中“风险因素”和“管理层对财务状况和经营成果的讨论和分析”中包含的风险，表10-Q已于2023年4月26日提交。

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