Lipocine’s brexanolone shows positive quantitative EEG results

Lipocine announced positive data from its qEEG study of its oral brexanolone, a proprietary bioidentical NAS being developed for the treatment of post-partum depression – PPD -. Results indicate robust central nervous system activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG. These results confirm GABAA positive allosteric modulation and support future development of oral brexanolone in neuropsychiatric indications. Following a single clinically relevant dose of oral brexanolone, subjects showed mean changes in all oscillatory spectral power bands. There was considerable beta band amplitude increase, including significant increase in beta2 amplitude across all cortical brain areas. Most of the treatment-related EEG changes were rapid occurring as early as 2 hours, with maximum and significant mean contrast values at 4 hours post dose with appreciable effects lasting 12 hours post-dose. Observed qEEG changes following oral brexanolone administration are consistent with therapies effective in managing depression, anxiety, tremor, and seizures. Oral brexanolone was well-tolerated in this Phase 1 study.