A recent phase 2 POLARIS study evaluated the effectiveness of mazindol extended-release (ER) treatment in treating narcolepsy. The study involved 67 participants who received either mazindol ER or a placebo for four weeks. Mazindol ER demonstrated significant improvements in cataplexy severity and sleepiness compared to the placebo. The treatment group showed clinically and statistically significant improvements in both cataplexy severity and sleepiness ratings.
An open-label extension study showed that patients who continued with mazindol ER for an additional six months experienced further improvement in excessive daytime sleepiness. Mazindol ER was well tolerated, with no unexpected adverse events reported. The therapy also reduced the number of weekly cataplexy episodes. Based on the positive results, the FDA authorized a phase 3 program to further evaluate the efficacy and safety of mazindol ER in patients with narcolepsy.
Reference: Meglio M. Clinical Improvements in Cataplexy Seen Through Mazindol Extended-Release Treatment. Neurology Live. Published June 13, 2023. Accessed June 26, 2023. https://www.neurologylive.com/view/clinical-improvements-cataplexy-seen-through-mazindol-extended-release-treatment
