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Monday, Axsome Therapeutics Inc (NASDAQ:AXSM) released data from the SYMPHONY Phase 3 trial of AXS-12 (reboxetine) in narcolepsy patients.
Narcolepsy is a sleep disorder that makes people very drowsy during the day. People with narcolepsy find it hard to stay awake for long periods.
AXS-12 met the primary endpoint by demonstrating a substantial and statistically significant reduction from baseline in weekly cataplexy (sudden loss of muscle tone while a person is awake leads to weakness and a loss of voluntary muscle control) attacks compared to placebo at Week 5, with reductions of 83% for AXS-12 and 66% for placebo.
AXS-12 rapidly reduced weekly cataplexy attacks, demonstrating at Week 1 a reduction of 56% compared to a reduction of 31% for placebo.
Remission of cataplexy, defined as a 100% reduction from baseline, was achieved at Week 5 by 33% of AXS-12 treated patients compared to 9.5% of placebo patients (p=0.008).
Achievement of remission was rapid, being experienced at Week 2 by 24% of AXS-12 treated patients compared to 4.5% of placebo patients (p=0.008).
AXS-12 increased the percentage of cataplexy-free days per week, defined as days with zero cataplexy attacks, to 84.5% at Week 5 compared to 22.6% for placebo (p=0.014).
AXS-12 significantly reduced excessive daytime sleepiness (EDS) severity, compared to placebo at Week 5, with mean reductions of 1.8 points for AXS-12 compared to 0.9 points for placebo. Rapid improvement in EDS was seen as early as Week 1 compared to the placebo.
Concurrent EDS and cataplexy response was achieved at Week 5 by 57% of patients treated with AXS-12 compared to 33% of placebo patients.
A decrease in inadvertent naps was experienced by 54% of AXS-12 patients at Week 5 compared to 28% of placebo patients.
Improvement on the Epworth Sleepiness Scale (ESS) was numerically greater for AXS-12 than for placebo, with mean reductions from baseline of 4.7 points for AXS-12 compared to 3.4 points for placebo.
Concurrent cognitive and cataplexy response was achieved at Week 5 by 41% of patients treated with AXS-12 compared to 17% of placebo patients (p=0.016).
Improvement from baseline in the Anxiety/Depression was achieved by 55% of patients treated with AXS-12 compared to 32% of placebo patients.
AXS-12 was well tolerated in the trial. There were no serious adverse events in the trial.
Price Action: AXSM shares are down 3.84% at $77.56 on the last check Monday.
Photo via Darko Stojanovic from Pixabay
Posted In: AXSM
