(RTTNews) - NLS Pharmaceutics AG (NLSP), a Swiss clinical-stage biopharmaceutical company, on Tuesday announced the initiation of a preclinical program evaluating its extended-release formulation of mazindol or Mazindol ER as a novel treatment for fentanyl dependence.
This move comes in response to the growing fentanyl crisis, which the CDC reports is responsible for 90% of overdose deaths involving synthetic opioids, with 105,007 drug overdose fatalities recorded in 2023.
Mazindol ER, a tetracyclic compound with a distinct pharmacological profile, targets multiple neurotransmitter pathways involved in opioid addiction.
The treatment aims to address key aspects of fentanyl dependence, including cravings, withdrawal symptoms, and cognitive impairments often associated with opioid withdrawal. Its unique action on the serotonin or 5-HT1A and orexin or OX2R receptors, as well as its partial agonist effect on the mu-opioid receptor or MOP, positions it as a promising non-opioid alternative to current treatments like methadone and buprenorphine.
The preclinical program, known as Study KO-943, will evaluate the safety, efficacy, and pharmacokinetics of Mazindol ER in opioid-exposed subjects, with a focus on craving reduction, withdrawal mitigation, and cognitive performance.
The study is expected to be completed within 12 to 18 months, with potential clinical development to follow based on positive results. Mazindol ER is patent-protected beyond 2038, and NLS plans to utilize initial findings to expand research and pursue regulatory approval for its use in treating fentanyl dependence.
This announcement marks a significant step for NLS Pharmaceutics as it continues to develop therapies for rare and complex central nervous system disorders, with other pipeline candidates including treatments for ADHD, Autism Spectrum Disorders, and circadian rhythm-related conditions.
Currently, NLSP is trading at $1.84 up by 1.64%.
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