Lipocine (NASDAQ: LPCN) has announced that the last patient has completed the final study visit in the Phase 3 trial of its oral brexanolon, LPCN 1154, for the treatment of postpartum depression (PPD).
According to Lipocine, LPCN 1154 has shown a positive safety profile, with all reported nervous system adverse events being mild to moderate in severity, and no instances of drug discontinuation, excessive sedation, loss of consciousness, or drug-related serious adverse events.
In a statement, Mahesh Patel, CEO of Lipocine, commented, “We are encouraged by the high study drug compliance and safety profile observed in this study, which we believe to be attributable to the short, 48-hour treatment duration, coupled with the regimen’s ease of use and tolerability. Provided the efficacy results are positive, the established safety profile could promote greater willingness among healthcare professionals to prescribe LPCN 1154 as a patient-centric treatment option for women suffering from postpartum depression.”
