mazindol controlled release (NLS-2) / NLS Pharma - LARVOL DELTA

NLS Pharmaceutics Announces Positive Results from Study KO-943 Demonstrating Mazindol Reduces Fentanyl-Induced Reward in Animal Models (PRNewswire) - "NLS Pharmaceutics Ltd...announced positive results from Study KO-943, a preclinical investigation evaluating the efficacy of Mazindol in mitigating fentanyl-induced conditioned place preference (CPP) in mice. The study, conducted by Key-Obs SAS, a leading preclinical CRO, provides evidence that Mazindol may offer a novel, non-opioid approach for the treatment of fentanyl use disorder — a condition contributing to over 75% of opioid-related overdose deaths in the United States....Fentanyl significantly increased place preference (p ≤ 0.05 vs. vehicle), confirming its potent rewarding effect; Mazindol at 0.5 mg/kg significantly reduced fentanyl-induced CPP (p ≤ 0.05; p ≤ 0.01 vs. fentanyl-only), bringing behavior close to baseline; The 0.25 mg/kg dose showed a trend toward reduction, indicating a dose-dependent effect."

Preclinical • Attention Deficit Hyperactivity Disorder

AMAZE: A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1 (clinicaltrials.gov) - P3 | N=48 | Not yet recruiting | Sponsor: NLS Pharmaceutics | Trial completion date: Feb 2025 ➔ Jul 2025 | Initiation date: Jan 2024 ➔ Jul 2024 | Trial primary completion date: Jan 2025 ➔ Jul 2025

Trial completion date • Trial initiation date • Trial primary completion date • Cataplexy • Narcolepsy • Sleep Disorder

AMAZE: A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1 (clinicaltrials.gov) - P3 | N=48 | Not yet recruiting | Sponsor: NLS Pharmaceutics | Trial completion date: Aug 2024 ➔ Feb 2025 | Initiation date: Jul 2023 ➔ Jan 2024 | Trial primary completion date: Jul 2024 ➔ Jan 2025

Trial completion date • Trial initiation date • Trial primary completion date • Cataplexy • Narcolepsy • Sleep Disorder

AMAZE: A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1 (clinicaltrials.gov) - P3 | N=48 | Not yet recruiting | Sponsor: NLS Pharmaceutics

New P3 trial • Cataplexy • Narcolepsy • Sleep Disorder

A four-week randomized, double-blind, placebo-controlled, phase 2 study of mazindol ER in the treatment of narcolepsy (SLEEP 2023) - P2 | "NLS-2 was generally safe and well-tolerated with no severe or serious adverse events or discontinuations due to adverse events. Conclusion In subjects with narcolepsy, NLS-2 significantly improved EDS and the number of cataplexy attacks compared with placebo."

Clinical • P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Clinician and Patient Global Impression in a Phase 2 Study of Mazindol (NLS-1021) in Adults with Narcolepsy Type 1 and Type 2 (SLEEP 2023) - P2 | "Patients were treated with mazindol ER (NLS-2) at once-daily 2 mg for one week and once-daily 3 mg thereafter or matching placebo (PBO) on a 1:1 ratio...Conclusion Mazindol ER resulted in significant improvements of cataplexy severity and sleepiness in both conditions as rated by both clinicians and participants. These secondary outcome results support the efficacy of mazindol ER on cataplexy attacks, in NT1 participants, and on sleepiness, in NT1 as well as in NT2 participants."

Clinical • P2 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Functional Outcomes of Sleep Questionnaire in a phase 2 study of mazindol ER in narcolepsy (SLEEP 2023) - P2 | "Patients were treated with mazindol ER (NLS-2) at once-daily 2 mg for one week and once-daily 3 mg thereafter or matching placebo (PBO) on a 1:1 ratio...The most frequently reported TEAEs (>5%) were dry mouth, nausea, decreased appetite and tachycardia. Conclusion Mazindol ER resulted in significant improvements of functional outcome measure FOSQ-10 These secondary outcome results support the efficacy of mazindol ER on cataplexy attacks, in NT1 patients, and on sleepiness, in NT1 as well as in NT2 patients."

P2 data • Cataplexy • CNS Disorders • Narcolepsy • Sleep Disorder

An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy (clinicaltrials.gov) - P2 | N=52 | Completed | Sponsor: NLS Pharmaceutics | Active, not recruiting ➔ Completed

Trial completion • Cataplexy • Narcolepsy • Sleep Disorder

An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy (clinicaltrials.gov) - P2 | N=52 | Active, not recruiting | Sponsor: NLS Pharmaceutics | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Cataplexy • Narcolepsy • Sleep Disorder

Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy (clinicaltrials.gov) - P2; N=60; Enrolling by invitation; Sponsor: NLS Pharmaceutics; Recruiting ➔ Enrolling by invitation

Clinical • Enrollment status • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy (clinicaltrials.gov) - P2; N=60; Enrolling by invitation; Sponsor: NLS Pharmaceutics; Recruiting ➔ Enrolling by invitation

Clinical • Enrollment status • Cataplexy • Narcolepsy • Sleep Disorder

An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: NLS Pharmaceutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cataplexy • Narcolepsy • Sleep Disorder

An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: NLS Pharmaceutics

New P2 trial • Cataplexy • Narcolepsy • Sleep Disorder