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Axsome Therapeutics Investigational Drug Lowers Risk Of Agitation Relapse In Alzheimer's Patients

  • Axsome Therapeutics Inc's (NASDAQ: AXSM) AXS-05 substantially and statistically significantly delayed the time to relapse and prevented relapse of agitation in patients with Alzheimer's disease, compared to placebo.

  • The ACCORD Phase 3 trial represented a 3.6-fold lower relapse risk than the placebo.

  • AXS-05 also met the key secondary endpoint of relapse prevention based on the relapse rates during the double-blind treatment period (7.5% of AXS-05 patients vs. 25.9% of placebo patients).

  • Related: Axsome's Depression Candidate Scores FDA Nod, Stock Surges To 52-High.

  • A statistically significant improvement was seen with open-label AXS-05 treatment at all time points starting at Week 1, with mean reductions from baseline of 11.0 points at Week 2 and 20.6 points at Week 5.

  • Both clinicians and caregivers reported rapid and substantial improvement in Alzheimer's disease agitation on global measures.

  • Clinicians reported improvement in agitation in 66.3% of patients at Week 2 and 86.3% at Week 5 after treatment with AXS-05.

  • Caregivers reported improvement in agitation in 67.5% of patients at Week 2 and 89.3% at Week 5 after treatment with AXS-05.

  • The rates of adverse events observed in the double-blind period were 28.3% in the AXS-05 group and 22.2% in the placebo group.

  • Price Action: AXSM shares are up 16.1% at $65.97 during the premarket session on the last check Monday.

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