ACCESS Newswire

Nutriband Inc.

Share
Nutriband Provides Product Development Update for Its Lead Product Aversa Fentanyl

ORLANDO, FL / ACCESSWIRE / June 20, 2024 / Nutriband Inc.("Company") (NASDAQ:NTRB)(NASDAQ:NTRBW) provides an update on its Aversa Fentanyl product development program to shareholders as it aims to complete scale-up of the commercial manufacturing process and move towards the single Phase 1 human abuse potential study prior to NDA filing.

  • As previously reported, the Company with its partner Kindeva Drug Delivery completed the feasibility agreement and entered into a commercial development and clinical supply agreement to manufacture product for the human abuse potential clinical study in support of a New Drug Application (NDA) to be submitted to FDA. The feasibility agreement was focused on adapting Kindeva's commercial transdermal manufacturing process to incorporate AVERSA™ abuse deterrent transdermal technology.
  • Nutriband is currently working with its partner Kindeva Drug Delivery to develop the commercial scale manufacturing process for the final product which will incorporate Nutriband's AVERSA™ abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system.
  • Recently, Kindeva Drug Delivery completed the validation of the aversive agent cleaning analytical methods required to allow work with the aversive agents, denatonium benzoate and capsaicin, on the commercial manufacturing line.
  • Once the final commercial product manufacturing process is completed, Nutriband intends to file an IND with the FDA and perform the pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in compliance with FDA Guidance.
  • Nutriband will file an Investigational New Drug (IND) application with the FDA prior to conducting the single Phase 1 human abuse potential clinical study required for its NDA. The IND will include the chemistry, manufacturing, and controls (CMC) information for the commercial product as well as the clinical study protocol for the human abuse potential study.
  • No Phase 2 or phase 3 Clinical Trials are required prior to submitting for approval.
  • AVERSA(TM) 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 Advances(1).

The pivotal laboratory assessment to be conducted is a series of in vitro manipulation and extraction studies designed to determine if the potentially abuse-deterrent properties of the product can be defeated or compromised based on physical and chemical manipulation of the product. Preliminary studies conducted to date have shown that the AVERSA technology is very difficult to defeat by various physical or chemical means.

The pivotal clinical study is a human abuse potential study performed to assess the impact of the potentially abuse-deterrent properties in a drug-experienced, recreational user population. The human abuse potential study is a randomized, double-blind, placebo-controlled and positive controlled crossover study comparing AVERSA Fentanyl to the currently marketed fentanyl patch which does not contain abuse-deterrent technology. The success of the human abuse potential study is based on the assessment drug liking using various instruments that are predictive of the likelihood of abuse.

Nutriband's AVERSA™ abuse-deterrent technology incorporates 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. 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.

(1) Health Advances Aversa Fentanyl market analysis report 2022

About Nutriband Inc.
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 deterrence technology. AVERSA™ technology can be incorporated 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.

About Kindeva
Headquartered in Woodbury, Minnesota, Kindeva Drug Delivery is a leading global contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Kindeva provides unique technologies and quality services to its customers, ranging from formulation and product development to commercial manufacturing. Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, intradermal drug delivery (microneedles) and connected drug delivery. Kindeva employs approximately 1,000 people worldwide. For more information, visit www.kindevadd.com.

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

To view this piece of content from www.accesswire.com, please give your consent at the top of this page.

About ACCESS Newswire

DK

Subscribe to releases from ACCESS Newswire

Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from ACCESS Newswire

From Office Flirtation to Bestselling Romance Novel: The Story Behind Patricia Dlamini's New Book Launch5.7.2025 00:00:00 CEST | Press release

From office flirtation to bestselling romance novel, the journey of author Patricia Dlamini captures the imagination of readers and aspiring writers alike. Her latest book, 'The Competitor's Kiss: When Rivalry Turns to Romance, Who Really Wins?,' takes inspiration from her own experiences in the corporate world, intertwining personal anecdotes with imaginative storytelling to create a captivating narrative that resonates with many. CAPE TOWN, ZA / ACCESS Newswire / July 4, 2025 / The story follows two colleagues who develop a romantic relationship amidst the challenges of office politics and career aspirations. As the protagonists navigate their feelings and professional lives, readers are treated to an engaging exploration of love, ambition, and the complexities of workplace dynamics. Dlamini's ability to blend humor with heartfelt moments allows the narrative to stand out in a crowded genre.Amazon.com: The Competitor's Kiss: When Rivalry Turns to Romance, Who Really Wins? Checkout Bo

Sweden, the Czech Republic, and Greece Crowned Champions of Harm Reduction in Brussels3.7.2025 06:00:00 CEST | Press release

BRUSSELS, BE / ACCESS Newswire / July 3, 2025 / Brussels transformed into a Champions League pitch for tobacco harm reduction as the World Vapers' Alliance (WVA) honoured Sweden, the Czech Republic, and Greece with the "Champions of Change" trophy for their outstanding progress in cutting smoking rates. The ceremony, staged in front of the European Parliament, shone a spotlight on the countries leading Europe's fight against smoking-while EU officials looked on from the sidelines. WVA Director Michael Landl, presenting the awards, remarked, "The EU is stuck in a cycle of prohibition and continues to overlook the evidence that's saving lives. Instead of embracing proven solutions, Brussels is making it harder for smokers to quit." Sweden led the celebrations, having become the world's first officially smoke-free nation, with just 4.5% of Swedish-born adults smoking-five times lower than the EU average and 16 years ahead of the EU's own goal. The Czech Republic and Greece were also recog

Fineqia Issues Bitcoin Yield ETP via DeFi; Yield Compounds Investors' BTC Holdings2.7.2025 17:00:00 CEST | Press release

LONDON, UK / ACCESS Newswire / July 2, 2025 / Fineqia International Inc. (CSE:FNQ)(OTC:FNQQF) (Frankfurt:FNQA), a digital asset and investment business, announces the Fineqia Bitcoin Yield Exchange Traded Product (ETP) (Ticker: YBTC, ISIN: LI1444931821), a listed product that enables investors to garner additional Bitcoin while holding it. YBTC targets an annual yield of 6% via decentralised finance (DeFi) activities on the blockchain. YBTC automatically converts this yield into Bitcoin (BTC), increasing an investor's BTC holdings without requiring any additional capital. Listed on the Vienna Stock Exchange (Wiener Börse), it is the first regulated, exchange-traded instrument in the world to provide BTC yield from DeFi protocols. The product is available for institutional and retail investors. "With YBTC, we've transformed Bitcoin from a store of value into a yield-generating digital asset," said Bundeep Singh Rangar, chief executive officer of Fineqia. "It allows investors to earn mor

Global Sports Brand U.S. Polo Assn. Launches in Brazil With Grupo Pasquini2.7.2025 13:15:00 CEST | Press release

WEST PALM BEACH, FL AND SAO PAULO, BRAZIL / ACCESS Newswire / July 2, 2025 / U.S. Polo Assn., the official brand of the United States Polo Association (USPA), is proud to announce its launch in the Brazilian market in partnership with Grupo Pasquini, a leading player in the country's fashion industry. This expansion reinforces the global, sport-inspired brand's presence in Latin America and further supports U.S. Polo Assn.'s strategic growth plan to reach new consumers around the world.U.S. Polo Assn. As U.S. Polo Assn. continues to expand its multi-billion-dollar global presence, Brazil marks an exciting new chapter in the brand's international journey. With its vibrant retail landscape and deep-rooted passion for lifestyle fashion, Brazil offers a natural fit for U.S. Polo Assn.'s authentic connection to the sport of polo. The debut collection in Brazil will showcase timeless, versatile styles across both menswear and womenswear, designed to honor the heritage of the sport while embr

Picktan Capital to Post Record Q2 Amid Market Buzz Over Possible IPO1.7.2025 20:55:00 CEST | Press release

LONDON, UK / ACCESS Newswire / July 1, 2025 / Picktan Capital, a London-headquartered wealth management firm managing over $7 billion in client assets globally, is attracting attention amid growing speculation about a potential public listing. The firm is on track to report its strongest quarterly performance to date, marking a significant milestone in its global growth strategy. With a strong emphasis on emerging technologies and disciplined capital deployment, Picktan Capital's momentum in 2024 has captured the interest of both investors and analysts. Picktan's second-quarter performance reflects a maturing investment approach grounded in both innovation and long-term value. The firm's activity across pivotal sectors, notably aerospace innovation, AI development, and satellite communications, has translated into meaningful gains and reinforced confidence in its forward strategy. Rather than chasing trends, Picktan has concentrated on sectors undergoing structural transformation. Its

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye