Nutriband Inc. Selects Commercial Brand Name for Abuse-Deterrent Fentanyl Patch

Key Developments Announced

• Nutriband Inc. (NASDAQ:NTRB, NASDAQ:NTRBW) has officially selected a commercial worldwide brand name for its lead product, an abuse-deterrent fentanyl transdermal patch, and will submit this name for FDA approval.
• The company has partnered with Brand Institute, Inc., a global leader in pharmaceutical and healthcare-related brand name and identity development, to create the product’s brand name and visual identity.
• The selected brand name will be submitted not only to the FDA, but also to other international regulatory agencies and the United States Patent and Trademark Office for trademark registration, aiming to secure full intellectual property rights both in the U.S. and globally.

Commercial and Regulatory Significance

• The abuse-deterrent fentanyl patch uses Nutriband’s AVERSA™ technology, designed to deter abuse, misuse, diversion, and accidental exposure of transdermal fentanyl. If approved, this could be the world’s first abuse-deterrent patch for fentanyl.
• The product has significant commercial potential, with projected peak annual U.S. sales estimated between \$80 million and \$200 million.
• While the initial focus is on the U.S. market, Nutriband is developing the product for all major medical markets worldwide, addressing the global unmet medical need for adequate pain management.

Strategic Importance of Brand Selection

• Developing a proprietary brand name for a prescription drug is crucial, as it helps prevent medication errors caused by look-alike or sound-alike names. Effective branding can reduce risks to patients and ensure safety in dispensing the product.
• Brand Institute holds a dominant position in drug name approvals, with a 75% global market share and 87% of FDA-approved drug names in 2024. Their expertise includes naming abuse-deterrent opioid products approved for U.S. sale.
• Regulatory support for the project is provided by Drug Safety Institute (DSI), Brand Institute’s wholly owned subsidiary led by former officials from FDA, EMA, Health Canada, USAN, and WHO. These experts co-authored naming guidance documents and have extensive experience in regulatory approval processes.

Technology and Intellectual Property Portfolio

• AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches, helping prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, including opioids and stimulants.
• This technology is protected by a broad international intellectual property portfolio, with patents granted in 46 countries, including the U.S., Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

Company and Partner Profiles

• Nutriband Inc. is primarily focused on developing a portfolio of transdermal pharmaceutical products. Its lead product is the abuse-deterrent fentanyl patch, utilizing AVERSA™ technology, which can be incorporated into any transdermal patch for drugs with abuse potential.
• Brand Institute, Inc. is the global leader in name development for pharmaceuticals and healthcare, with over 5,000 marketed brand names and 1,800 USAN/INN nonproprietary names for nearly 1,600 clients.
• Drug Safety Institute comprises regulatory experts from global health agencies, responsible for approving or rejecting brand name applications to prevent medication errors.

Forward-Looking Statements and Risks

• Nutriband’s press release contains forward-looking statements regarding the development, regulatory approval, and commercialization of its abuse-deterrent fentanyl patch.
• Risks include the company’s ability to secure patent protection, obtain necessary financing, complete clinical testing, achieve FDA and international regulatory approval, successfully market products, attract and retain key personnel, and adapt to business or strategic changes.

Potential Shareholder Impact

• The selection and submission of a commercial brand name is a critical milestone for Nutriband’s lead product, potentially accelerating the path to FDA and international approvals.
• The significant market opportunity, proprietary technology, and broad patent portfolio may enhance Nutriband’s competitive positioning, potentially impacting share value if approvals and commercial success follow.
• Investors should monitor regulatory submissions and responses, as approval or rejection of the brand name or product could materially affect Nutriband’s future prospects and share price.

Disclaimer

This article is for informational purposes only and does not constitute investment advice. Forward-looking statements in the press release are subject to risks and uncertainties, and actual results may differ materially. Investors should conduct their own due diligence and consult with financial advisors before making investment decisions.

View NutriBand Inc. Historical chart here