Heroin Dependence

ZURICH, SWITZERLAND / ACCESSWIRE / October 21, 2024 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company dedicated to developing therapies for rare and complex central nervous system disorders, is pleased to announce that its Japanese patent application No. 2020-513594 has been granted. The patent covers the use of Mazindol ER (extended-release) for the treatment of heroin dependence, providing a new therapeutic strategy for opioid use disorder. “The development of mazindol as a treatment for substance use disorder could represent a significant breakthrough, offering new hope for patients battling addiction. It is crucial we align our strategy with the evolving landscape of pharmaceutical innovation in this area.” said Alex Zwyer, Chief Executive Officer of NLSP. “This application highlights the continued commitment from NLS to pioneer therapeutic approaches to address significant unmet medical needs.” Key Highlights of this Patent Mazindol ER for Heroin Dependence : Mazindol, a tetracyclic compound with unique pharmacological properties, has shown promising in vivo results in reducing heroin dependence by modulating neurotransmitter systems involved in reward signaling and addiction pathways. The patent protects the use of Mazindol ER as a treatment for opioid addiction, specifically targeting heroin, one of the most potent and addictive opioids. Mechanism of Action : Unlike traditional opioid agonists and antagonists, Mazindol works by indirectly modulating the reward systems of the brain, targeting opioid receptors such as μ-opioid, κ-opioid, and δ-opioid receptors. By influencing these receptors, Mazindol reduces cravings and compulsive drug-seeking behaviors, helping to mitigate the effects of opioid use disorder without inducing the same level of dependence associated with other treatments. Focus on Long-Term Efficacy : The patent includes claims for the sustained-release formulation of Mazindol, which allows for a steady release of the drug over time, improving patient compliance and reducing the risk of relapse. This extended-release formulation is designed to maintain therapeutic levels of the drug in the bloodstream for prolonged periods, providing more consistent symptom management for individuals recovering from heroin addiction. Scientific Basis Opioid Use Disorder (OUD), particularly heroin addiction, poses a significant public health challenge worldwide. Heroin binds strongly to opioid receptors in the brain, leading to intense euphoria followed by physical dependence and withdrawal symptoms. Traditional treatments often rely on opioid substitution therapies, which can carry their own risks of dependence. Mazindol offers an innovative, non-opioid approach that addresses the brain’s addiction circuitry, potentially reducing the risk of relapse and improving recovery outcomes. The unique effect of Mazindol on heroin dependence lies in its ability to regulate the meso-corticolimbic system, which includes the ventral tegmental area (VTA) and nucleus accumbens-key regions in the brain’s reward circuitry. By normalizing these pathways, Mazindol helps reduce the compulsive behaviors associated with opioid use disorder, offering hope for individuals struggling with heroin addiction. Appeal Decision in Japan NLS Pharmaceutics successfully appealed the original rejection of its patent application, receiving a favorable decision from the Japan Patent Office (JPO) on October 2, 2024. The granted patent, which includes eight claims, provides robust protection for Mazindol ER and its specific use in treating opioid dependence, particularly heroin addiction. This decision reflects an innovative contribution to addiction medicine and positions Mazindol ER as a potentially transformative treatment for heroin dependence in Japan and beyond. About NLS Pharmaceutics Ltd. NLS Pharmaceutics Ltd. is a global development-stage biopharmaceutical company working with internationally recognized scientists and world-class partners to develop innovative therapies for patients with rare and complex central nervous system disorders. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of successfully developing and commercializing product candidates. For more information, visit . Safe Harbor Statement This press release contains forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS discusses potential benefits of its products and the granted patent. Forward-looking statements are based on the current expectations of NLS management and are subject to numerous factors and uncertainties that could cause actual results to differ. These factors include technology changes, delays or obstacles in launching clinical trials, and the non-approval of NLS products by regulatory agencies. NLS undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this release unless required by law. Detailed risk information is included in NLS’s filings with the U.S. Securities and Exchange Commission (SEC), available at . Contact: Investor Relations Contact InvestorRelations@nls-pharma.com SOURCE: NLS Pharmaceutics AG View the original press release on accesswire.com

A 20-year study examined the long term relationship between cannabis and illicit opioid use. Overall results were inconsistent and showed no strong link. The study showed that clinicians and policymakers should be cautious about relying on cannabis to reduce opioid use, especially in the US and Canada. A 20-year Australian study has found no evidence to suggest cannabis reduces illicit opioid use, and it may not be an effective long-term method of reducing harm for those with an opioid use disorder or problematic use of opioids. Published in the American Journal of Psychiatry, the University of Sydney led study is one of the longest of its kind. Between 2001 to 2022, the study involved a group of 615 people with heroin dependence, many of whom also used cannabis. Additional analysis also found no consistent evidence between cannabis and other opioid use, including opioids that were prescribed. Opioid use is currently responsible for more death and disability than any other illicit drug. Opioid and cannabis use disorders make up approximately 77 percent of all illicit drug disorders. The researchers say clinicians and policymakers should be cautious about relying on cannabis to reduce problematic opioid use or as a potential strategy to help manage the opioid crisis, especially given a global shift towards cannabis legalisation and recognition as a therapeutic product. In the United States, some states have policies that allow patients to substitute their prescribed opioids with cannabis. The Canadian Government is currently reviewing the Cannabis Act in the context of medicinal cannabis for opioid dependence. To examine the impact of cannabis on opioid use, and vice versa, researchers used a recently developed statistical technique. This allowed them to account for influential factors on opioid and cannabis use in the data such as age and made it possible to focus on individual changes in substance use over time. "Our investigation shows that cannabis use remains common among this population, but it may not be an effective long term strategy for reducing opioid use ," says lead author Dr Jack Wilson, from The Matilda Centre for Research in Mental Health and Substance Use, at the University of Sydney. "There are claims that cannabis may help decrease opioid use or help people with opioid use disorders keep up with treatment. "But it's crucial to note those studies examine short- term impact, and focus on treatment of chronic pain and pain management, rather than levels of opioid use in other contexts." Another key finding was cannabis use is common among those with an opioid use disorder, and so there needs to be clinical services that offer additional support for people who would like to reduce cannabis use. "Opioid use disorders are complex and unlikely to be resolved by a single treatment," says Dr Wilson. "The best way to support them is evidence-based holistic approaches that look at the bigger picture, and include physical, psychological, and pharmacotherapy therapies."

More than 100,000 deaths in the U.S. alone each year due to overdose Global Opioid Use Disorder market projected to be approximately $5 Billion by 2028 Mazindol classified by the U.S. Drug Enforcement Agency (DEA) as a Schedule IV controlled substance versus currently available Schedule II treatments ZURICH, SWITZERLAND / ACCESSWIRE / December 1, 2022 /NLS Pharma Ltd. (NASDAQ NLSP)(NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 16/645,306, which covers Mazindol as a method of treatment for heroin dependence and substance use disorders comprising administering mazindol or composition comprising mazindol to a subject, wherein the substance is an opioid and Mazindol is administered daily at a daily dosage range from between 3 mg and 16 mg. NLS expects this patent to be issued within the next few months and it is expected to expire no earlier than 2038. "This patent allowance further supports our commitment of bringing innovative science to the treatment of addiction and our shared vision of developing safe and effective drugs to improve mental and behavioral disorders," said Alex Zwyer, CEO of NLS Pharmaceutics. "With more than 35 million people estimated to be suffering from substance use disorders and far too many deaths linked to opioid overdose, we believe that there is a clear need for additional treatments to combat this epidemic. Importantly, Mazindol works differently than currently available treatments, such as methadone, that are equally addictive and harder to withdraw from than the opioids they are replacing. Mazindol is classified by the U.S. Drug Enforcement Agency (DEA) as a Schedule IV controlled substance, defined as medicines with a low potential for abuse and a low risk of dependence." The global opioid use disorder (OUD) market is valued at just under $3 billion and is projected to grow to nearly $5 billion by 2028 period. Opioids are a class of drugs that includes the illegal drug heroin as well as powerful pain relievers available by prescription, such as oxycodone (Oxycontin), hydrocodone (Vicodin), codeine, morphine, fentanyl, methadone, and many others. In the U.S. alone, over 100,000 lives were lost in 2021 due to drug overdoses, at an average of nearly 295 people per day. Drug overdoses are the leading cause of death for Americans ages 18-45, with approximately two-thirds being attributable to opioids. The USPTO issued a Notice of Allowance for the Company's patent application entitled, "Mazindol treatment for heroin dependence and substance use disorder." A Notice of Allowance is issued after the USPTO decides that a patent can be granted from an application. About NLS Pharmaceutics Ltd. NLS Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company led by an experienced management team with a track record of developing and repurposing product candidates to treat rare and complex central nervous system disorders. The Company's lead product candidate, Quilience®, is a proprietary extended-release formulation of Mazindol (Mazindol ER) and is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders such as idiopathic hypersomnia (IH), for which NLS recently obtained Orphan Disease Designation (ODD) from the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Mazindol is a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. A Phase 2 multi-center U.S. clinical trial evaluating Quilience® in adult subjects suffering from narcolepsy met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile. NLS also successfully completed a Phase 2 study in the U.S. evaluating Nolazol® (Mazindol Controlled-Release) in adult subjects suffering from ADHD. The study met all primary and secondary endpoints and Nolazol® was well-tolerated. Quilience® has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD. Safe Harbor Statement This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the expected timing of the issuance of the patent and the earliest expiration date of the patent, and the potential benefits in the use of Mazindol for the treatment of substance abuse disorders. These forward-looking statements and their implications are based on the current expectations of the management of NLS only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS' products may not be approved by regulatory agencies, NLS' technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS' process; NLS' products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS' patents may not be sufficient; NLS' products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' annual report on Form 20-F for the year ended December 31, 2021 filed with the Securities and Exchange Commission (SEC), which is available on the SEC's website, and in subsequent filings made by NLS with the SEC. For additional information: Marianne Lambertson (investors & media) NLS Pharmaceutics Ltd. +1 239.682.8500 ml@nls-pharma.com SOURCE: NLS Pharmaceutics AG View source version on accesswire.com: