Nutriband Receives Notice of Allowance for U.S. Trademark Covering AVERSA(TM) Abuse Deterrent Technology

Rhea-AI Summary

Nutriband Inc. (NASDAQ:NTRB) has received a Notice of Allowance from the USPTO for its AVERSA™ trademark, a key component of its abuse-deterrent transdermal patch technology. The company's lead product, AVERSA™ Fentanyl, is progressing towards commercial manufacturing scale-up in partnership with Kindeva Drug Delivery. Nutriband plans to file an IND application with the FDA, preceding pivotal studies to demonstrate the abuse-deterrent properties of AVERSA™ Fentanyl.

The upcoming human abuse potential study will compare AVERSA™ Fentanyl to a current fentanyl patch without abuse-deterrent features. Preliminary studies indicate AVERSA™ technology's high resistance to manipulation. A market analysis projects potential peak annual U.S. sales of $80 million to $200 million for AVERSA™ Fentanyl, highlighting its significant market potential in abuse-deterrent pharmaceuticals.

Positive

• Received Notice of Allowance for AVERSA™ trademark from USPTO
• Progressing towards commercial manufacturing scale-up for AVERSA™ Fentanyl
• Planning to file IND application with FDA for pivotal studies
• Preliminary studies show high resistance to manipulation for AVERSA™ technology
• Potential peak annual U.S. sales of $80-200 million for AVERSA™ Fentanyl

Negative

• None.

Financial Analyst

For investors, the Notice of Allowance from the USPTO regarding the AVERSA™ trademark marks a significant step forward for Nutriband. This development is important because it provides a layer of legal protection and market exclusivity for Nutriband's unique technology, which aims to prevent the abuse and misuse of transdermal pharmaceutical products like fentanyl patches.

From a financial perspective, the partnership with Kindeva Drug Delivery and the progression toward human abuse potential clinical studies are notable milestones. Given the high market potential outlined in the report by Health Advances, with peak annual U.S. sales predicted to be between $80 million and $200 million, the successful commercialization of AVERSA™ Fentanyl could significantly boost Nutriband's revenue streams.

However, investors should be mindful of the regulatory hurdles and clinical study requirements that still need to be met. These processes are both time-consuming and expensive and the outcome is not guaranteed. The success of the upcoming Investigational New Drug (IND) application and subsequent pivotal clinical study will be important in determining the product's market viability.

In the short term, the news is likely to have a positive effect on Nutriband's stock price due to the reduced uncertainty around the trademark. However, long-term success will depend on meeting FDA guidelines and successfully bringing the product to market.

Medical Research Analyst

The Notice of Allowance for the AVERSA™ trademark is a pivotal development for Nutriband in the medical research community. This trademark is tied to Nutriband's platform technology that aims to mitigate the abuse and misuse of potent drugs like fentanyl. The company's lead product, AVERSA™ Fentanyl, operates within a important space in pharmaceutical development, especially given the ongoing opioid crisis in the U.S.

It's important to appreciate that the AVERSA™ technology's resistance to physical and chemical manipulation offers a promising solution to a significant public health issue. The upcoming human abuse potential study, which involves a rigorous double-blind, placebo-controlled and positive-controlled crossover design, is designed to provide robust data on the drug's abuse deterrent properties. This study's design aligns with FDA guidelines, a important factor for regulatory approval.

However, it is essential to recognize the inherent risks and challenges associated with such clinical trials. The outcomes may vary and even promising preliminary data are not always indicative of final success. Stakeholders should remain cautiously optimistic while closely monitoring the progress of these studies.

Overall, for those interested in the healthcare and pharmaceutical sectors, this development highlights Nutriband's commitment to innovation and addressing critical issues within the industry.

Market Research Analyst

The Notice of Allowance for the AVERSA™ trademark is a key milestone that positions Nutriband in a favorable market trajectory. The news highlights the company's strategic moves in securing intellectual property, which can serve as a competitive advantage in the abuse deterrent pharmaceutical market.

The market analysis by Health Advances projecting peak annual U.S. sales between $80 million and $200 million is a strong indicator of the potential market demand for such innovative solutions. This is especially relevant given the increasing regulatory emphasis on abuse deterrent formulations in response to the opioid crisis.

From a market perspective, the successful commercialization of AVERSA™ Fentanyl could enable Nutriband to capture a significant share of the transdermal drug delivery market. The company's alignment with an established partner like Kindeva Drug Delivery further strengthens its market positioning by leveraging Kindeva's expertise in large-scale commercial manufacturing.

Nonetheless, investors should remain aware of the competitive landscape. The abuse deterrent pharmaceutical market is evolving and other companies may also be developing similar technologies. Therefore, the ability to successfully navigate through clinical trials and regulatory approvals will be pivotal for Nutriband’s market success.

In summary, this strategic development enhances Nutriband's market potential, offering promising prospects for future growth.

ORLANDO, FL / ACCESSWIRE / July 15, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a developer of transdermal pharmaceutical products, today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on July 9, 2024, for trademark application Serial Number 98117984, covering the mark "AVERSA™." The Notice of Allowance signifies that the USPTO is expected to grant a trademark registration for this application following the completion of administrative processes.

The AVERSA™ trademark is integral to Nutriband's platform technology which can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband's lead product under development is AVERSA™ Fentanyl, an abuse deterrent fentanyl transdermal system.

Nutriband, in partnership with Kindeva Drug Delivery, is progressing towards completing the scale-up of the commercial manufacturing process for AVERSA™ Fentanyl. This partnership has successfully moved from a feasibility agreement to a commercial development and clinical supply agreement aimed at manufacturing product for the upcoming human abuse potential clinical study. This study is crucial for the New Drug Application (NDA) that Nutriband plans to submit to the FDA.

Upon completion of the commercial manufacturing process, Nutriband will file an Investigational New Drug (IND) application with the FDA. This filing will precede the pivotal laboratory and clinical evaluations needed to demonstrate the abuse-deterrent properties of AVERSA™ Fentanyl, in line with FDA Guidance. The IND will include comprehensive chemistry, manufacturing, and controls (CMC) information and the clinical study protocol for the human abuse potential study.

The pivotal clinical study will involve a randomized, double-blind, placebo-controlled, and positive-controlled crossover design, comparing AVERSA™ Fentanyl to a currently marketed fentanyl patch without abuse-deterrent technology. This human abuse potential study will assess the drug's "liking" among recreational users, which is predictive of the likelihood of abuse. Preliminary studies have shown that AVERSA™ technology is highly resistant to physical and chemical manipulation, reinforcing its potential effectiveness as an abuse deterrent.

According to a market analysis report by Health Advances, AVERSA™ Fentanyl has the potential to reach peak annual U.S. sales of $80 million to $200 million. This reflects the significant impact that AVERSA™ technology could have on the market for abuse deterrent pharmaceutical products.

About AVERSA™ Technology

Nutriband's AVERSA™ abuse deterrent transdermal technology is designed to incorporate aversive agents into transdermal patches, deterring abuse by making the experience unpleasant. This technology is especially significant for drugs like fentanyl, which have a high potential for abuse. AVERSA™ aims to ensure that these essential medications remain accessible to patients who need them while enhancing their safety profiles. The AVERSA™ technology is supported by a robust intellectual property portfolio, with patents granted in the United States and several other countries including Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.

About Nutriband Inc.

Nutriband Inc. is primarily engaged in developing a portfolio of transdermal pharmaceutical products. The Company's lead product in development is an abuse deterrent fentanyl patch that incorporates AVERSA™ technology. This technology can be integrated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

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.

Forward-Looking Statements

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. 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, 2024 and Forms 10-Q, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

For more information, contact:

RedChip Companies, Inc.
Email: NTRB@Redchip.com
Phone: 1-407-644-4256

Address:

431 E Horatio Ave, Suite #100
Maitland, FL 32751
Nutriband Inc.
Phone: 407-377-6695
Email: Support@nutriband.com

SOURCE: Nutriband Inc.

View the original press release on accesswire.com

FAQ

What is the status of Nutriband's AVERSA™ trademark application?

Nutriband (NTRB) received a Notice of Allowance from the USPTO on July 9, 2024, for the AVERSA™ trademark application, indicating expected trademark registration after administrative processes.

What is Nutriband's AVERSA™ Fentanyl product?

AVERSA™ Fentanyl is Nutriband's (NTRB) lead product under development, an abuse-deterrent fentanyl transdermal system designed to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential.

What are the projected sales for Nutriband's AVERSA™ Fentanyl?

According to a market analysis report by Health Advances, AVERSA™ Fentanyl has the potential to reach peak annual U.S. sales of $80 million to $200 million for Nutriband (NTRB).

What is the next step for Nutriband's AVERSA™ Fentanyl development?

Nutriband (NTRB) plans to file an Investigational New Drug (IND) application with the FDA, which will precede pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA™ Fentanyl.