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NLS Pharmaceutics Secures Key Patent in Japan for Mazindol ER in the Treatment of Heroin Dependence

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NLS Pharmaceutics (NASDAQ:NLSP) has secured a key patent in Japan for Mazindol ER in the treatment of heroin dependence. The patent covers the use of extended-release Mazindol for opioid use disorder, offering a new therapeutic strategy. Mazindol, a tetracyclic compound, has shown promising results in reducing heroin dependence by modulating neurotransmitter systems involved in reward signaling and addiction pathways.

Unlike traditional opioid treatments, Mazindol works by indirectly modulating the brain's reward systems, targeting opioid receptors without inducing the same level of dependence. The sustained-release formulation allows for steady drug release, improving patient compliance and reducing relapse risk. The patent includes eight claims, providing robust protection for Mazindol ER's use in treating opioid dependence in Japan.

NLS Pharmaceutics (NASDAQ:NLSP) ha ottenuto un brevetto fondamentale in Giappone per il Mazindol ER nel trattamento della dipendenza da eroina. Il brevetto copre l'uso del Mazindol a rilascio prolungato per il disordine da uso di oppioidi, offrendo una nuova strategia terapeutica. Il Mazindol, un composto tetraciclico, ha mostrato risultati promettenti nella riduzione della dipendenza da eroina modulando i sistemi di neurotrasmettitori coinvolti nei segnali di ricompensa e nelle vie di dipendenza.

Rispetto ai trattamenti oppioidi tradizionali, il Mazindol agisce modulando indirettamente i sistemi di ricompensa del cervello, mirato ai recettori degli oppioidi senza indurre lo stesso livello di dipendenza. La formula a rilascio prolungato consente un rilascio costante del farmaco, migliorando l'aderenza del paziente e riducendo il rischio di ricaduta. Il brevetto include otto rivendicazioni, fornendo una protezione robusta per l'uso del Mazindol ER nel trattamento della dipendenza da oppioidi in Giappone.

NLS Pharmaceutics (NASDAQ:NLSP) ha asegurado una patente clave en Japón para el Mazindol ER en el tratamiento de la dependencia a la heroína. La patente cubre el uso de Mazindol de liberación prolongada para el trastorno por uso de opioides, ofreciendo una nueva estrategia terapéutica. El Mazindol, un compuesto tetracíclico, ha mostrado resultados prometedores en la reducción de la dependencia a la heroína al modular los sistemas de neurotransmisores involucrados en la señalización de recompensa y las vías de adicción.

A diferencia de los tratamientos opioides tradicionales, el Mazindol actúa modulando indirectamente los sistemas de recompensa del cerebro, apuntando a los receptores de opioides sin inducir el mismo nivel de dependencia. La formulación de liberación sostenida permite una liberación constante del fármaco, mejorando la adherencia del paciente y reduciendo el riesgo de recaída. La patente incluye ocho reclamaciones, proporcionando una protección robusta para el uso del Mazindol ER en el tratamiento de la dependencia a opioides en Japón.

NLS Pharmaceutics (NASDAQ:NLSP)는 일본에서 Mazindol ER에 대한 핵심 특허를 확보하여 헤로인 중독 치료에 사용되고 있습니다. 이 특허는 오피오이드 사용 장애 치료를 위한 Mazindol의 지속 방출 사용을 다루고 있으며, 새로운 치료 전략을 제공합니다. tetracyclic 화합물인 Mazindol은 보상 신호 전달 및 중독 경로에 관련된 신경 전달 물질 시스템을 조절함으로써 헤로인 의존도를 줄이는 데 유망한 결과를 보였습니다.

전통적인 오피오이드 치료와는 달리 Mazindol은 뇌의 보상 시스템을 간접적으로 조절하여 오피오이드 수용체를 타겟팅하지만 같은 수준의 의존성을 유도하지 않습니다. 지속 방출 제형은 약물의 일정한 방출을 가능하게 하여 환자의 순응도를 개선하고 재발 위험을 줄입니다. 이 특허는 여덟 가지 청구 항목을 포함하고 있어 일본에서 오피오이드 의존증 치료에 대한 Mazindol ER의 사용에 대한 강력한 보호를 제공합니다.

NLS Pharmaceutics (NASDAQ:NLSP) a obtenu un brevet clé au Japon pour le Mazindol ER dans le traitement de la dépendance à l'héroïne. Le brevet couvre l'utilisation de Mazindol à libération prolongée pour le trouble lié à l'utilisation d'opioïdes, offrant une nouvelle stratégie thérapeutique. Le Mazindol, un composé tétracyclique, a montré des résultats prometteurs pour réduire la dépendance à l'héroïne en modulant les systèmes de neurotransmetteurs impliqués dans la signalisation de récompense et les voies d'addiction.

Contrairement aux traitements opioïdes traditionnels, le Mazindol fonctionne en modulant indirectement les systèmes de récompense du cerveau, ciblant les récepteurs opioïdes sans induire le même niveau de dépendance. La formulation à libération soutenue permet un relâchement constant du médicament, améliorant ainsi l'observance des patients et réduisant le risque de rechute. Le brevet comprend huit revendications, offrant une protection robuste pour l'utilisation de Mazindol ER dans le traitement de la dépendance aux opioïdes au Japon.

NLS Pharmaceutics (NASDAQ:NLSP) hat sich ein wichtiges Patent in Japan für Mazindol ER zur Behandlung von Heroinabhängigkeit gesichert. Das Patent umfasst die Verwendung von Mazindol mit verlängerter Freisetzung zur Behandlung von Opioidgebrauchsstörungen und bietet eine neue therapeutische Strategie. Mazindol, eine tetracyclische Verbindung, hat vielversprechende Ergebnisse bei der Reduzierung von Heroinabhängigkeit gezeigt, indem es die Neurotransmittersysteme moduliert, die an der Belohnungssignalgebung und den Suchtpfaden beteiligt sind.

Im Gegensatz zu traditionellen Opioidbehandlungen wirkt Mazindol, indem es die Belohnungssysteme des Gehirns indirekt moduliert und die Opioidrezeptoren ohne das gleiche Maß an Abhängigkeit anspricht. Die verzögerte Freisetzungsformulierung ermöglicht eine gleichmäßige Freisetzung des Medikaments, was die Patientencompliance verbessert und das Rückfallrisiko verringert. Das Patent umfasst acht Ansprüche und bietet einen robusten Schutz für die Anwendung von Mazindol ER zur Behandlung von Opioidabhängigkeit in Japan.

Positive
  • Secured key patent in Japan for Mazindol ER in treating heroin dependence
  • Mazindol ER offers a non-opioid approach to treating opioid addiction, potentially reducing relapse risk
  • Extended-release formulation improves patient compliance and provides consistent symptom management
  • Successful appeal of initial patent rejection, demonstrating innovation in addiction medicine
Negative
  • None.

Insights

The granting of this patent in Japan for Mazindol ER in treating heroin dependence is a significant development for NLS Pharmaceutics. It expands their intellectual property portfolio and potentially opens up a new market for opioid use disorder treatment. The unique mechanism of action of Mazindol, targeting multiple opioid receptors without inducing the same level of dependence as traditional treatments, could be a game-changer in addiction medicine.

However, investors should note that this is still in the early stages. While the patent is promising, it doesn't guarantee market success. The company will need to conduct clinical trials to prove efficacy and safety in this new indication. The opioid treatment market is competitive, with established players and various treatment approaches already available.

From a financial perspective, this patent could potentially increase the company's valuation in the long term if Mazindol ER proves successful in clinical trials and reaches the market. However, given NLS Pharmaceutics' current market cap of just $6.4 million, it's clear the market is taking a cautious approach. Investors should closely monitor the company's progress in developing this new indication and its ability to secure funding for further research and development.

The potential use of Mazindol ER for heroin dependence represents an innovative approach in addiction treatment. Its mechanism of action, which indirectly modulates the brain's reward system, could offer significant advantages over current opioid agonist and antagonist therapies. The extended-release formulation is particularly noteworthy, as it may improve treatment adherence and reduce the risk of relapse - two critical factors in managing opioid use disorder.

However, it's important to emphasize that while this patent is promising, it's just the beginning. Rigorous clinical trials will be necessary to establish Mazindol ER's efficacy and safety profile in treating heroin addiction. The addiction treatment field has seen many promising therapies fail in later-stage trials, so cautious optimism is warranted.

If successful, Mazindol ER could address a significant unmet need in addiction medicine, particularly in Japan where opioid use disorder treatment options are more compared to Western countries. The non-opioid nature of Mazindol could also make it an attractive option for patients and healthcare providers concerned about the risks associated with opioid-based treatments.

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 www.nlspharma.com.

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 www.sec.gov.

Contact:

Investor Relations Contact
InvestorRelations@nls-pharma.com
www.nlspharma.com

SOURCE: NLS Pharmaceutics AG



View the original press release on accesswire.com

FAQ

What is the purpose of NLS Pharmaceutics' newly granted Japanese patent for Mazindol ER?

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.

How does Mazindol ER differ from traditional opioid addiction treatments?

Unlike traditional opioid agonists and antagonists, Mazindol works by indirectly modulating the brain's reward systems, targeting opioid receptors without inducing the same level of dependence associated with other treatments.

What are the potential benefits of Mazindol ER's extended-release formulation for treating heroin addiction?

The extended-release formulation allows for steady drug release over time, improving patient compliance, reducing relapse risk, and providing more consistent symptom management for individuals recovering from heroin addiction.

When was NLS Pharmaceutics' (NLSP) Japanese patent for Mazindol ER granted?

NLS Pharmaceutics received a favorable decision from the Japan Patent Office on October 2, 2024, granting the patent after a successful appeal of the original rejection.

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