Positive Phase III data in narcolepsy from Axsome

US central nervous system (CNS) disorders specialist Axsome Therapeutics (Nasdaq: AXSM) today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity.

The company noted that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint in the ENCORE Phase III trial, demonstrating a statistically-significant improvement in the frequency of cataplexy attacks compared to placebo. AXS-12 was also well tolerated with long-term dosing with a safety profile consistent with that observed in previously completed trials.

ENCORE was a multi-enter, two-period Phase III trial evaluating the long-term efficacy and safety of AXS-12 in patients with narcolepsy with cataplexy, consisting of a 6-month open-label AXS-12 treatment period, followed by a three-week double-blind, placebo-controlled, randomized withdrawal period. The trial enrolled 68 patients in the six-month AXS-12 treatment period. Patients (n=42) were then randomized in a 1:1 ratio to continue treatment with AXS-12 or to discontinue AXS-12 and switch to placebo for three weeks.