ORLANDO, FL - Nutriband Inc. (NASDAQ:NTRB) announced its plan to file for FDA approval of AVERSA™ Fentanyl, a fentanyl transdermal patch with abuse-deterrent properties, using a streamlined regulatory pathway. The patch incorporates Nutriband's AVERSA™ technology into an existing FDA-approved fentanyl system developed by Kindeva Drug Delivery.
The company is pursuing a 505(b)(2) New Drug Application (NDA), which allows for a more expedited review process by referencing existing FDA data. This pathway requires only one Phase 1 human abuse potential clinical study, bypassing the need for Phase 2 or 3 trials. The study is designed to demonstrate the patch's lower abuse potential compared to conventional fentanyl patches.
A successful Phase 1 study could lead to an expedited six-month FDA review, shorter than the standard 10-month cycle. If approved, AVERSA™ Fentanyl could become the first abuse-deterrent fentanyl patch on the market.
The product has a projected peak annual sales potential of $80 million to $200 million in the U.S., according to a Health Advances market analysis report.
Nutriband's AVERSA™ technology aims to decrease the risk of abuse, misuse, or accidental exposure of drugs with abuse potential by incorporating aversive agents into transdermal patches. This technology is supported by a broad intellectual property portfolio with patents in multiple countries.
The development of AVERSA™ Fentanyl represents a significant step in Nutriband's focus on creating safer transdermal pharmaceutical products for drugs susceptible to abuse. The global opioid market, valued at $22.8 billion in 2022, highlights the importance of advancements like Nutriband's in combating prescription drug abuse.
This announcement is based on a press release statement and contains forward-looking statements subject to risks and uncertainties.
InvestingPro Insights
Nutriband Inc. (NASDAQ:NTRB) is navigating the complex pharmaceutical landscape with its innovative AVERSA™ Fentanyl patch, and investors are keeping a close eye on the company's financial health and market performance. According to InvestingPro data, Nutriband has a market capitalization of approximately $25.72 million. Despite the company's innovative strides, analysts are skeptical about its profitability in the near term, as reflected in the negative P/E ratio of -4.47, which further adjusts to -5.07 over the last twelve months as of Q3 2024.
The company's stock has experienced a significant return over the last week, with a 24.08% price total return, and a strong return over the last month, at 18.29%. This suggests a growing investor confidence potentially tied to the recent developments and future prospects of AVERSA™ Fentanyl. However, with no dividends being paid to shareholders, investors are likely banking on capital gains for returns.
InvestingPro Tips highlight that while Nutriband is not profitable over the last twelve months, it does operate with a moderate level of debt and its liquid assets exceed short-term obligations, indicating a degree of financial stability. For investors interested in a deeper dive into Nutriband's financials and future outlook, InvestingPro offers additional tips and insights. To access these, consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at https://www.investing.com/pro/NTRB. There are 6 more InvestingPro Tips available that could provide further clarity on the company's financial position and market potential.
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