ORLANDO, FL - Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW), a pharmaceutical company specializing in transdermal drug delivery, has announced progress in its Aversa Fentanyl patch program. The company is moving forward with scaling up its commercial manufacturing process in partnership with Kindeva Drug Delivery, aiming toward a pivotal Phase 1 human abuse potential study, a key step before filing a New Drug Application (NDA) with the FDA.
Nutriband has completed the feasibility agreement with Kindeva, transitioning into commercial development and clinical supply agreement phases. This collaboration is intended to adapt Kindeva's FDA-approved transdermal fentanyl patch system to include Nutriband's AVERSA™ abuse deterrent technology.
Recently, Kindeva completed the validation of analytical methods for cleaning aversive agents, such as denatonium benzoate and capsaicin, on the commercial manufacturing line. This development allows the progression towards the final commercial product manufacturing process.
Nutriband plans to file an Investigational New Drug (IND) application with the FDA, which will encompass the commercial product's chemistry, manufacturing, and controls (CMC) information, along with the clinical study protocol for the human abuse potential study. Importantly, no Phase 2 or Phase 3 clinical trials are required before submitting the NDA for approval.
The company anticipates that AVERSA™ Fentanyl could achieve peak annual US sales ranging from $80 million to $200 million, based on a market analysis report by Health Advances.
The upcoming pivotal laboratory assessment will include in vitro studies to determine whether the abuse-deterrent properties of AVERSA™ technology can be compromised. Preliminary studies have indicated that the technology is resistant to physical or chemical manipulation.
The human abuse potential study, essential for the NDA, will compare AVERSA Fentanyl to a marketed fentanyl patch without abuse-deterrent features in a controlled environment among drug-experienced, recreational users.
AVERSA™ technology aims to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential by incorporating aversive agents into transdermal patches. Nutriband holds a broad patent portfolio for this technology in multiple countries.
The information reported is based on a press release statement from Nutriband Inc.
In other recent news, Nutriband Inc. has made several significant developments. First, the company has appointed Sergei Glinka to its board of directors, following his $4.5 million investment in the company's recent private placement. This investment is expected to support the completion of the FDA approval process for Nutriband's AVERSA™ technology, a transdermal patch designed to deter the abuse of fentanyl.
In addition, Nutriband has entered into an exclusive supplier agreement with Fit For Life Group (FFL), tasking its subsidiary Active Intelligence with manufacturing duties for FFL's upcoming product launch. Nutriband's portfolio focuses on the development of transdermal solutions that incorporate AVERSA™ technology to prevent drug abuse and misuse.
Furthermore, Nutriband has closed a private placement funding round, securing $8.4 million to advance the company's lead product, AVERSA™ Fentanyl. This funding is earmarked for the completion of clinical development and the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for AVERSA™ Fentanyl.
Lastly, Nutriband announced its plan to file for FDA approval of AVERSA™ Fentanyl using a streamlined regulatory pathway. The company is pursuing a 505(b)(2) New Drug Application (NDA), which allows for a more expedited review process.
InvestingPro Insights
As Nutriband Inc. (NASDAQ:NTRB) advances its Aversa Fentanyl patch program, the company's financial health and market performance become increasingly relevant to investors monitoring its progress. According to InvestingPro, Nutriband holds a stronger financial position by maintaining more cash than debt on its balance sheet. This liquidity could be crucial as the company scales up its commercial manufacturing process and conducts pivotal studies.
Despite recent challenges, with the stock experiencing a significant drop over the last week, analysts remain optimistic about Nutriband's potential, anticipating sales growth in the current year. This outlook may align with the company's expectations for its AVERSA™ Fentanyl patch, which is projected to generate substantial peak annual sales in the U.S. market.
From a valuation standpoint, Nutriband is currently trading at a high revenue valuation multiple, which could reflect investor confidence in the company's growth trajectory and its abuse-deterrent technology's market potential. Additionally, Nutriband's market capitalization stands at $57.28 million, and it has a negative P/E ratio of -7.09, indicating that it is not currently profitable.
For investors looking for more in-depth analysis, InvestingPro offers additional tips on Nutriband, including insights into its sales growth and liquidity. Interested readers can find more InvestingPro Tips by visiting https://www.investing.com/pro/NTRB and can benefit from a special offer using the coupon code PRONEWS24 for an extra 10% off a yearly or biyearly Pro and Pro+ subscription.
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