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REPEAT - Nutriband Announces Successful Meeting Completed With United States FDA For Its Abuse Deterrent Fentanyl Patch
The Manila Times· 2025-10-28 15:12
Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent transdermal system) through commercialization. Nutriband received final meeting minutes from FDA and is incorporating the feedback into the development program as it moves forward to an IND filing in support of a Human Abuse Potential (HAP) clinical study for the product.ORLANDO, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company en ...
REPEAT — Nutriband Announces Successful Meeting Completed With United States FDA For Its Abuse Deterrent Fentanyl Patch
Globenewswire· 2025-10-28 15:05
Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent transdermal system) through commercialization. Nutriband received final meeting minutes from FDA and is incorporating the feedback into the development program as it moves forward to an IND filing in support of a Human Abuse Potential (HAP) clinical study for the product. ORLANDO, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company e ...
Nutriband Announces Successful Meeting Completed With United States FDA For Its Abuse Deterrent Fentanyl Patch
Globenewswire· 2025-10-28 11:00
Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent transdermal system) through commercialization. Nutriband received final meeting minutes from FDA and is incorporating the feedback into the development program as it moves forward to an IND filing in support of a Human Abuse Potential (HAP) clinical study for the product. ORLANDO, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company e ...
Nutriband Co-Founder Gareth Sheridan Returns as CEO
Globenewswire· 2025-10-27 11:00
ORLANDO, Fla., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) has announced that Company founder, Gareth Sheridan has returned as Company CEO. During the period of August 10 until October 27 , Co-Founder and Chairman, Serguei Melnik had taken over the responsibilities of CEO. Mr Sheridan has returned to the position of CEO effective immediately and will guide the company through the final 2025 framework towards the target NDA filing in 2026 for AVERSA Fentanyl. AVERSA FENTANYL ...
Nutriband Signs Agreement With Brand Institute to Develop the Commercial Brand Name for Its Abuse Deterrent Fentanyl Patch
Globenewswire· 2025-10-10 11:00
Nutriband initiates commercial worldwide brand name development for its lead product, an abuse deterrent transdermal system. Nutriband has partnered with Brand Institute, Inc, the global leader in pharmaceutical and healthcare-related brand name and identity development. ORLANDO, Fla., Oct. 10, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that through its 4P Therapeutics subsidia ...
Nutriband Files Provisional Patent Application for Enhanced Transdermal Abuse Deterrent Technology
Globenewswire· 2025-10-08 12:30
Nutriband files provisional patent application to enhance its AVERSA™ transdermal abuse deterrent technology being developed for patches containing opioids and stimulants with a potential for abuse. Nutriband’s AVERSA™ abuse-deterrent technology consists of a proprietary aversive agent coating that employs taste aversion to deter oral abuse and reduce accidental exposure. ORLANDO, Fla., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of pres ...
Nutriband Inc. Quarterly Report Highlights Record Revenue for Q2, 2025 up 50.87% YOY and Strategic Progress Toward NDA Filing for AVERSA Fentanyl
Globenewswire· 2025-09-10 13:15
Core Insights - Nutriband Inc. reported strong financial results for the six months ended July 31, 2025, with a cash position of $6.9 million and total assets valued at $10.17 million, supporting the development of its lead product, AVERSA™ Fentanyl [1][5] - The company achieved record revenue of $1,289,884 from its kinesiology tape contract manufacturing services, reflecting a year-over-year increase of 50.87% [2] - AVERSA Fentanyl is on track for development, with the NDA relying on a single phase 1 Human Abuse Potential study, eliminating the need for Phase 2 or Phase 3 trials before submission [3] Product Development - AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch globally, with estimated peak annual sales potential ranging from $80 million to $200 million [4] - The second application, AVERSA Buprenorphine, is projected to reach peak annual sales of up to $130 million [4] - The company emphasizes its AVERSA™ technology, designed to prevent abuse, misuse, and accidental exposure of drugs with abuse potential [6] Financial Position - As of July 31, 2025, Nutriband's stockholders' equity amounted to $8.5 million, indicating a solid financial foundation for ongoing development and commercialization efforts [5]
Nutriband CEO Gareth Sheridan Seeks Nomination in Upcoming Irish Presidential Election
GlobeNewswire News Room· 2025-08-11 09:00
Core Viewpoint - Nutriband Inc. CEO Gareth Sheridan will temporarily step aside to participate in the Irish Presidential Election, with Chairman Serguei Melnik taking over as interim CEO during this period [1][2][3] Company Leadership Transition - Gareth Sheridan will step down for three months, with the nomination hearings and election occurring in September and October [1] - Serguei Melnik, co-founder and Chairman, will assume CEO responsibilities and guide the company towards its NDA filing target in 2026 [2] Strategic Focus - Melnik, with over 20 years of experience in capital markets, will continue to execute the company's strategic development and focus on enhancing shareholder value [2] - Sheridan emphasized the strength of the company's team as its core asset and expressed confidence in meeting planned targets during his absence [3] Product Development - Nutriband's lead product, AVERSA Fentanyl, has received FDA approval for a meeting request, positioning it as a potential first-of-its-kind abuse-deterrent opioid patch [4] - AVERSA Fentanyl is projected to achieve peak annual US sales between $80 million and $200 million, with plans to expand into major global markets [4] Intellectual Property - The AVERSA technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including the US, Europe, and China [5] Company Overview - Nutriband Inc. focuses on developing transdermal pharmaceutical products, with AVERSA technology designed to prevent the abuse and accidental exposure of drugs with abuse potential [6]
FDA Grants Nutriband Meeting Request for Aversa™ Fentanyl Abuse Deterrent Fentanyl Patch
GlobeNewswire News Room· 2025-08-08 12:00
Core Viewpoint - The FDA has granted Nutriband a Type C Meeting to discuss the Chemistry, Manufacturing, and Controls plans for its AVERSA™ FENTANYL product, which aims to provide an abuse-deterrent transdermal system for fentanyl [1][2]. Group 1: Product Development - Nutriband is collaborating with Kindeva to develop AVERSA™ FENTANYL, integrating Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch [1][2]. - The AVERSA™ technology incorporates aversive agents into transdermal patches to prevent abuse, misuse, and accidental exposure of drugs with abuse potential, particularly opioids [3][6]. Group 2: Market Potential - AVERSA FENTANYL could be the first abuse-deterrent opioid patch, with potential peak annual sales in the U.S. estimated between $80 million and $200 million [4]. - The company aims to address the global unmet medical need for effective pain management by making AVERSA FENTANYL available in major medical markets worldwide [4]. Group 3: Intellectual Property - The AVERSA™ abuse-deterrent technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including the U.S., Europe, Japan, and China [5][6]. Group 4: Company Overview - Nutriband is focused on developing a portfolio of transdermal pharmaceutical products, with its lead product being the abuse-deterrent fentanyl patch [7].
Nutriband and Kindeva Complete Commercial Manufacturing Process Scale-up for Aversa™ Fentanyl Abuse Deterrent Fentanyl Patch
Globenewswire· 2025-06-18 11:00
Core Viewpoint - Nutriband has successfully completed the commercial manufacturing process scale-up for its lead product, Aversa™ Fentanyl, in partnership with Kindeva, marking a significant milestone towards developing a commercially viable abuse-deterrent fentanyl patch [1][3]. Group 1: Product Development - Aversa™ Fentanyl combines Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch, and is manufactured at Kindeva's advanced transdermal facility in the United States [2]. - The next steps include manufacturing clinical supplies and filing an Investigational New Drug (IND) application with the FDA to initiate a human abuse liability clinical study [2]. Group 2: Market Potential - Aversa Fentanyl has the potential to be the first abuse-deterrent opioid patch on the market, aimed at deterring abuse and reducing accidental exposure risks, with projected peak annual US sales between $80 million to $200 million [5]. - The company plans to initially focus on the US market while also targeting global markets due to the widespread unmet medical need for effective pain management [5]. Group 3: Technology and Intellectual Property - Nutriband's AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent drug abuse, ensuring that these medications remain accessible to patients in need [4][7]. - The technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including major markets such as the United States, Europe, and China [6][7].