As Fentanyl Crisis Escalates, Abuse-Deterrent Formulations to Zero in on the Rising Epidemic of Opiate Abuse

PALM BEACH, Fla., Sept. 24, 2024 (GLOBE NEWSWIRE) — FN Media Group News Commentary – Abuse-deterrent transdermal technology can be used to prevent the misuse of drugs with abuse potential, such as fentanyl, by incorporating aversive agents into transdermal patches. Abuse-deterrent opioid formulations (ADFs) are designed to make it more difficult to abuse opioids by making them less attractive or rewarding, or by increasing the difficulty of manipulating them. ADFs can help reduce the risk of adverse effects associated with snorting or injecting opioids, and may also help prevent medication errors. Active companies in the industry include: Nutriband Inc. (NASDAQ: NTRB), Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Eli Lilly and Company (NYSE: LLY), Novartis AG (NYSE: NVS), Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX).

Some benefits of ADFs include: 

• Reduced risk of abuse: ADFs can help reduce the risk of abuse, addiction, and substance use disorder. 
• Reduced risk of overdose: ADFs can help reduce the risk of opioid overdose and poisoning. 
• Reduced risk of medication errors: ADFs can help prevent medication errors, such as when a caregiver crushes an extended-release opioid to mix into applesauce.

According to OXFORD Academic: “The misuse and abuse of prescription opioids constitute a growing public health problem, which is described in detail in The Burden of the Nonmedical Use of Prescription Opioid Analgesics. Recent efforts to decrease abuse of opioids through formulation engineering have focused on creating broader impediments to abuse, such as incorporating physical barriers, combining agonists with antagonists, including components that cause aversion, and formulating opioid prodrugs, with the goal of reducing abuse by oral and intranasal, as well as, routes. Several of these newer formulations are in late-stage clinical testing and, if approved, may reach the US market later this year. The true “abuse-resistance” or “abuse-deterrence” of these products will be established only when epidemiologic data on their impact confirming such effects are available.” As reported by the U.S. Food & Drug Administration: “The FDA is encouraging the development of prescription opioids with abuse-deterrent formulations (ADFs) to help combat the opioid crisis. The agency recognizes that abuse-deterrent opioids are not abuse- or addiction-proof but are a step toward products that may help reduce abuse.”

Nutriband Inc. (NASDAQ: NTRB) RECEIVES CHINA PATENT NOTICE OF ALLOWANCE FOR ITS AVERSA™ ABUSE DETERRENT TRANSDERMAL TECHNOLOGY

• Notice of Allowance received from Chinese National Intellectual Property Administration (CNIPA) for a patent application covering its Nutriband AVERSA™ abuse deterrent transdermal technology
• Nutriband abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products

Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has received a Notice of Allowance from the Chinese National Intellectual Property Administration (CNIPA) for patent application entitled, “Abuse and Misuse Deterrent Transdermal Systems,” which protects its AVERSA™ abuse deterrent transdermal technology.

The Aversa™ abuse deterrent technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, Mexico, Canada, Australia, and China.

Nutriband’s AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse while making sure that these drugs remain accessible to those patients who really need them.

Nutriband abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products. Preliminary studies have shown that the coating is very difficult to scrape off and the technology has a patented immediate and extended-release profile which presents an additional layer of deterrence to prevent the aversive layer from easily being washed off in an attempt to separate the drug from the aversive agents.

Nutriband is currently working with its partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products, to develop its lead product, AVERSA™ Fentanyl, which incorporates Nutriband’s AVERSA™ abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system.

AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million. (Health Advances Aversa Fentanyl market analysis report 2022). CONTINUED… Read this full press release and more news for NTRB at: https://www.financialnewsmedia.com/news-ntrb

Other recent developments in the industry of note include:

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced recently that a new analysis from the European cohort of the RIM-TD open-label extension (OLE) study revealed that deutetrabenazine treatment of patients with Tardive Dyskinesia (TD) was associated with long term improvement of TD symptoms. The improvement in symptoms was sustained throughout the three-year study, and deutetrabenazine was well tolerated. The data were presented at the European College of Neuropsychopharmacology (ECNP) annual congress in Milan.

TD is a stigmatising and debilitating involuntary movement disorder characterised by repetitive movements of the tongue, lower face, jaw, and limbs, which develops in around 15%-25% of patients receiving antipsychotic medications for conditions such as schizophrenia, bipolar disorder, and major depressive disorder. 

As part of the Lilly 30×30 pipeline efforts, Eli Lilly and Company (NYSE: LLY) is collaborating with NIDA through a Screening Agreement to explore the potential of some early-phase therapies that might be repurposed for the treatment of opioid use disorder (OUD).

OUD is the chronic use of opioids that causes clinically significant distress or impairment. More than 9.5 million people over age 12 in the U.S. alone misused opioids in the past year. Opioid and other addictive disorders disproportionately affect people with limited resources. Nearly half of non-elderly adults with OUD in the United States have low incomes and almost a quarter live in poverty. Although there are three drugs approved by the U.S. Food and Drug Administration for the treatment of opioid dependence, misuse of opioids remains a significant public health concern, and there is a high unmet need to develop new and effective treatments for opioid and other addictive disorders.

Sandoz Inc., a Novartis AG (NYSE: NVS) division, and Pear Therapeutics, Inc., in 2019 announced the US commercial launch of reSET-O(TM) for patients with Opioid Use Disorder (OUD). reSET-O, cleared by the US Food and Drug Administration (FDA) in December, is immediately available.

The reSET-O prescription digital therapeutic (PDT) is a 12-week cognitive behavioral therapy intended to be used in addition to outpatient treatment. It includes transmucosal buprenorphine, a commonly used medication to treat opioid addiction, and contingency management designed to provide incentives to reinforce positive behaviors. reSET-O is available by prescription only for patients 18 years or older under the care of a clinician.

“The launch of reSET-O provides an important technology-based treatment option for patients with Opioid Use Disorder and may fundamentally change how they interact with their therapies,” said Richard Francis, CEO, Sandoz. “At Sandoz, we are proud and excited to push the frontiers of medical innovation.”

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) earlier this year announced the availability of Over the Counter (“OTC”) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, following Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”). Amneal’s Naloxone HCI Nasal Spray, manufactured in the U.S., is a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication that is widely used to help treat drug overdose from opioids, including heroin, fentanyl and prescription opioid medications.

“With today’s launch, Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription. Our business is deeply rooted in a commitment to helping others. By enhancing access to naloxone nasal spray, we hope to get this affordable emergency treatment into the hands of even more people who could potentially save countless families and communities from further heartache and loss,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

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