ORLANDO, FL - Nutriband Inc. (NASDAQ:NTRB), a pharmaceutical company specializing in transdermal drug delivery systems, is set to secure a trademark for its AVERSA™ technology after receiving a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on July 9, 2024. The AVERSA™ mark is a key component of Nutriband's efforts to combat drug abuse and misuse, particularly in the context of opioid medications such as fentanyl.
The AVERSA™ technology integrates aversive agents into transdermal patches to deter abuse by rendering the experience unpleasant, targeting drugs with high abuse potential. Nutriband's flagship product, AVERSA™ Fentanyl, is an abuse-deterrent fentanyl transdermal system currently under development.
In collaboration with Kindeva Drug Delivery, Nutriband is advancing the commercial-scale manufacturing process for AVERSA™ Fentanyl. This progress follows the transition from a feasibility agreement to a commercial development and clinical supply agreement, which will support the upcoming human abuse potential clinical study. This study is vital for the New Drug Application (NDA) submission to the FDA.
Upon finalizing the manufacturing process, Nutriband will file an Investigational New Drug (IND) application with the FDA. The IND will include detailed chemistry, manufacturing, and controls (CMC) information, along with the clinical study protocol for assessing the abuse-deterrent properties of AVERSA™ Fentanyl as per FDA guidelines.
The upcoming clinical trial will be a randomized, double-blind, placebo-controlled, and positive-controlled crossover study. It will compare AVERSA™ Fentanyl against a marketed fentanyl patch lacking abuse-deterrent features, evaluating the drug's appeal among recreational drug users—a predictor of abuse potential. Preliminary research suggests that AVERSA™ technology is highly resistant to manipulation, which could enhance its role as an abuse deterrent.
A market analysis by Health Advances estimates that AVERSA™ Fentanyl could achieve peak annual sales between $80 million and $200 million in the U.S. market, highlighting the significant potential impact of the AVERSA™ technology in the realm of abuse-deterrent pharmaceuticals.
Nutriband's AVERSA™ technology is backed by an extensive intellectual property portfolio, with patents granted in multiple countries, including the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.
This article is based on a press release statement from Nutriband Inc. The company cautions that its forward-looking statements carry risks and uncertainties, and actual results may differ materially from those projected.
In other recent news, Nutriband Inc. has made significant strides in its Aversa Fentanyl patch program. The pharmaceutical company has announced progress in scaling up its commercial manufacturing process in partnership with Kindeva Drug Delivery, moving toward a pivotal Phase 1 human abuse potential study, a crucial step before filing a New Drug Application (NDA) with the FDA.
Nutriband has completed its feasibility agreement with Kindeva, transitioning into commercial development and clinical supply agreement phases.
In addition, Nutriband has appointed Sergei Glinka to its board of directors following his $4.5 million investment in the company. This investment is expected to support the FDA approval process for Nutriband's AVERSA™ technology. Nutriband also entered into an exclusive supplier agreement with Fit For Life Group (FFL), delegating manufacturing duties to its subsidiary Active Intelligence for FFL's upcoming product launch.
Furthermore, Nutriband secured $8.4 million in a private placement funding round to advance AVERSA™ Fentanyl, its lead product. The funding is designated for the completion of clinical development and the submission of an NDA with the FDA for AVERSA™ Fentanyl.
Lastly, Nutriband plans to file for FDA approval of AVERSA™ Fentanyl using a streamlined regulatory pathway. These recent developments reflect Nutriband's ongoing efforts to progress its innovative pharmaceutical solutions.
InvestingPro Insights
Nutriband Inc. (NASDAQ:NTRB) has made significant strides with its AVERSA™ technology, which is gaining traction as a potential game-changer in the pharmaceutical industry's fight against opioid abuse. The financial metrics and market performance of the company provide a broader perspective on its growth and stability.
According to InvestingPro data, Nutriband has a market capitalization of $72.29 million, reflecting the market’s valuation of the company as of the last twelve months leading up to Q1 2025. Despite facing a challenging revenue growth, with a slight decrease of -2.97% over the last twelve months, the company's gross profit margin stands at a healthy 39.89%, indicating a strong ability to control the cost of goods sold and retain earnings from sales.
InvestingPro Tips highlight that Nutriband holds more cash than debt, which is a positive sign of financial health and may provide the company with the flexibility to invest in further research and development for its AVERSA™ technology. Moreover, analysts are expecting sales growth in the current year, which could be a reflection of the market's optimism about the potential of AVERSA™ Fentanyl and its abuse-deterrent properties.
Investors interested in deeper analysis will find a wealth of additional InvestingPro Tips for Nutriband Inc., including insights on trading patterns, valuation multiples, and profitability. With a total of 12 tips available on InvestingPro, users can gain a comprehensive understanding of the company's financial health and market position. To access these tips and more, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
As Nutriband continues to advance its AVERSA™ technology through clinical studies and seeks regulatory approvals, these financial metrics and expert analyses will be crucial for investors monitoring the company's progress and potential impact in the pharmaceutical industry.
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