Nutriband Closes $8.4M Private Placement for Commercial Development of Aversa(R) Fentanyl Transdermal Patch Through FDA Submission
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With Nutriband's recent private placement, it's clear that the company is on a path to potentially revolutionize the opioid patch market. AVERSA Fentanyl's designation as an abuse-deterrent form of medication addresses a critical public health concern. From a commercial standpoint, the forecasted peak sales suggest a considerable revenue stream for Nutriband, contingent on FDA approval and market penetration.
The distinctive aspect of this drug's path to the market is the 505(b)(2) NDA regulatory pathway. This pathway allows for a potentially expedited review process, which is a strategic advantage. This not only speeds up the time to market but could also be a mitigating factor for the company's R&D expenditure. However, the reliance on a single Phase 1 study, while cost-effective, also presents risks if the study does not conclusively establish the desired abuse-deterrent properties.
Investors should note the potential for Expedited FDA Review, which is often a catalyst for stock movement. However, the ambitious timeline can be a double-edged sword, posing risks if any unforeseen regulatory challenges arise. While the focus on abuse deterrence is timely and aligns with FDA priorities, there is no guarantee of approval and the narrow focus on a single clinical trial may raise efficacy or safety concerns that could impact the approval outcome and thus investor returns.
Nutriband's strategy involves leveraging AVERSA technology across multiple products, which could be pivotal for creating a strong moat in the competitive opioid market. Patents on abuse-deterrent formulations can provide substantial competitive advantage and long-term value. The breadth and enforceability of the patents covering AVERSA technology will be important in determining Nutriband's ability to fend off generic competition and command pricing power.
Investors should be aware of the importance of the intellectual property landscape when considering the long-term prospects of the company. Moreover, if Nutriband's technology proves easy to integrate with existing delivery systems, it could become a significant player in licensing deals, providing another potential revenue stream beyond direct product sales.
Private Placement of
Nutriband working to complete the commercial scale-up prior to performing the pivotal laboratory assessment and clinical study required for FDA approval
AVERSA Fentanyl being developed as 505(b)(2) NDA on single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed.
ORLANDO, FL / ACCESSWIRE / April 24, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has closed the
Nutriband is currently working with its partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization, 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.
With this latest round of funding and based on progress made on the commercial transdermal manufacturing process scale-up to date, Nutriband is pushing towards the following development milestones:
- FDA Pre-IND Meeting
- Pivotal Laboratory Manipulation and Extraction Study
- FDA IND Filing
- Pivotal Human Abuse Potential Clinical Study
- New Drug Application Filing 505(b)(2) NDA
- FDA Review and Approval (Expedited)
The Company is targeting Q1 of 2025 to file its NDA for marketing approval.
Once the final commercial product manufacturing process is completed, Nutriband intends to perform the pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in compliance with FDA Guidance for Industry Abuse-Deterrent Opioids - Evaluation and Labeling. Nutriband intends to obtain agreement on the pivotal studies required for approval in an FDA Pre-Investigational New Drug Application (Pre-IND) Meeting.
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 of drug liking using various instruments that are predictive of the likelihood of abuse. Nutriband will file an Investigational New Drug (IND) application with the FDA prior to conducting the Phase 1 human abuse potential clinical study. 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.
Following a successful Phase 1 clinical abuse potential study, Nutriband intends to file a 505(b)(2) New Drug Application (NDA) to the FDA for marketing approval of AVERSA™ Fentanyl. The 505(b)(2) NDA regulatory pathway 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.
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.
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.
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.
1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
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. 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.
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-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.
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, 2023, filed April 26, 2023, the Forms 10-Q's filed subsequent to the Form 10-K in 2023, 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.
Contact Information:
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.
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FAQ
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