Biogen/Sage's zuranolone helps reduce postpartum depression symptoms, meets main goal of trial
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Biogen (NASDAQ:BIIB) and Sage Therapeutics's (NASDAQ:SAGE) oral drug zuranolone helped reduce symptoms of postpartum depression (PPD), meeting the main goal of a late-stage study.
The phase 3 trial, dubbed SKYLARK, evaluated zuranolone 50-mg once daily for 14 days, compared to placebo in women with PPD, a type of depression many women experience during and after child birth.
The companies said women treated with zuranolone 50 mg (n=98) showed a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the main goal, compared to placebo (n=97).
The study met all key secondary goals with rapid and statistically significant improvement in depressive symptoms as early as Day 3 in women receiving the drug, compared to placebo, which was sustained at all measured timepoints through Day 45, the companies said in a June 1 press release.
The companies noted that zuranolone 50 mg was generally well-tolerated and showed a safety profile consistent with prior studies.
The most common treatment emergent adverse events (TEAEs) (>5% in the zuranolone 50 mg arm) were somnolence, dizziness, sedation, headache, diarrhea, nausea, urinary tract infection and COVID-19.
The companies noted that no evidence of withdrawal symptoms or increased suicidal ideation or behavior were seen.
"If approved, zuranolone would be the first oral medication specifically indicated to treat PPD," said Sage CEO Barry Greene.
Sage (SAGE) and Biogen (BIIB) are developing zuranolone â which is a two-week, once-daily oral drug â to treat major depressive disorder (MDD) and PPD.
The companies have already begun a rolling submission of an application seeking U.S. Food and Drug Administration approval of zuranolone to treat MDD.