#Switzerland #NLS Pharmaceutics #Zurich #Mazindol ER #Fentanyl Dependence

NLS Pharmaceutics Initiates Preclinical Program for Mazindol ER

NLS Pharmaceutics Ltd. has recently announced the beginning of a preclinical initiative to study Mazindol ER (Extended-Release) as a novel treatment for individuals dependent on fentanyl. Given that fentanyl dependence has escalated into a critical global health crisis, the launch of this program is both timely and necessary.

The Urgent Need for Innovation in Opioid Treatment

In recent years, the Centers for Disease Control and Prevention (CDC) reported a staggering 105,007 deaths from drug overdoses in 2023, with synthetic opioids, including fentanyl, responsible for about 90% of these fatalities. The pressing nature of this situation has led the government to declare fentanyl dependence a national public health emergency, emphasizing the need for alternative therapies that do not involve opioids.

Alex Zwyer, Chief Executive Officer of NLS, stressed the commitment of the company to explore the unique properties of Mazindol, which targets several neurotransmitter systems involved in opioid addiction. This preclinical program is considered a significant step toward developing an innovative therapeutic approach that may offer relief to those suffering from this debilitating condition.

Understanding Mazindol ER’s Pharmacological Potential

Mazindol is a tetracyclic compound known for its distinct pharmacological profile that could potentially help mitigate opioid dependence by engaging with multiple neurotransmitter pathways. Some key actions of Mazindol ER include:

• - 5-HT1A receptor modulation: This action helps regulate mood and anxiety, addressing the psychological challenges faced during opioid withdrawal.
• - Mu-opioid receptor interaction: The partial modulation of the opioid effects may reduce cravings and withdrawal symptoms without reinforcing the addiction cycle.
• - Orexin-2 receptor partial agonism: This action supports the restoration of sleep-wake cycles and enhances cognitive stability, critical factors during opioid withdrawal.

These mechanisms illustrate how Mazindol ER could address the numerous challenges associated with fentanyl dependence, thereby paving the way for a more effective treatment paradigm.

Scientific Justification for Mazindol ER

Given fentanyl’s potent nature, approximately 50 times stronger than heroin, traditional treatments like methadone and buprenorphine have been challenged by issues of dependence and regulatory hurdles. Mazindol ER offers a potentially effective non-opioid alternative that aims to rectify the neurochemical imbalances caused by opioid addiction while promoting recovery through its multimodal pharmacological actions. The sustained-release formulation further ensures consistent therapeutic effects and encourages patient compliance.

Objectives and Future Steps of the Preclinical Study

The preclinical study, designated as Study KO-943, will specifically aim at:

• - Assessing the safety and efficacy of Mazindol ER in models of fentanyl dependence.
• - Analyzing pharmacokinetics and pharmacodynamics in subjects exposed to opioids.
• - Investigating the effects of Mazindol ER on cravings, withdrawal symptoms, and cognitive performance.

With an anticipated completion time frame of 12 to 18 months, positive outcomes could prompt NLS to pursue regulatory approval for clinical trials.

Dr. Konofal, Chief Scientific Officer of NLS, mentioned that there is a belief within the company that Mazindol ER could redefine the treatment landscape for opioid addiction. The strategic plan for development includes critical early-stage investments to gather necessary data facilitating larger future studies and potential routes toward commercialization.

NLS Pharmaceutics’ Robust Patent Portfolio

To further support its endeavors, NLS Pharmaceutics has secured multiple patents relevant to the development of Mazindol ER, including:

• - U.S. Patent No. 11,207,271: Covering oral formulations of mazindol designed for various medical applications.
• - U.S. Patent No. 11,596,622: Specifically awarded for using Mazindol ER in treating heroin dependence, thus providing a valuable strategy against opioid use disorder.

These patents bolster NLS's intellectual property position and further validate its ongoing development processes.

Looking Ahead

NLS Pharmaceutics aims to use initial findings from the preclinical studies to broaden research efforts and commercialize Mazindol ER particularly for treating fentanyl dependence. The company also has other promising candidates in its development pipeline, including treatments for ADHD, circadian rhythm disorders, and unique applications relating to military use and space missions.

About NLS Pharmaceutics Ltd.

Founded in 2015, NLS Pharmaceutics is a development-stage biopharmaceutical company based in Switzerland, focused on innovative therapies for patients with rare and intricate central nervous system disorders. The company continues its collaboration with respected scientists and partners to address unmet medical needs within this challenging healthcare landscape.

As the opioid crisis intensifies, the implications of research like that being undertaken by NLS Pharmaceutics could prove transformative for countless individuals grappling with addiction, restoring hope for effective recovery pathways.