- Sage Therapeutics and partner Biogen plan to next year ask the Food and Drug Administration for approval of their experimental antidepressant zuranolone in postpartum depression after reporting positive results from a late-stage clinical trial of the drug on Wednesday.
- Women who were treated with the drug, which is given as a pill, experienced significantly improved depressive symptoms after 15 days, compared to those in the study who received a placebo. The effect of treatment was sustained through four and six weeks, the companies said.
- Sage and Biogen, which teamed up on zuranolone in 2020, have already begun a submission to the FDA for approval of the drug in major depressive disorder based on data from previous studies. Sage's shares rose as much as 11% on the news Wednesday morning.
Zuranolone was the chief draw for Biogen to promise more than $3 billion to Sage in signing their partnership nearly two years ago. The oral drug is designed to work differently and more quickly than other antidepressants, a profile that the companies expect could be a compelling option for doctors and patients if the medicine is approved.
Still, clinical trial results have been mixed and negative study data in 2019 forced Sage to redraw its plans and test a higher dose of the drug. Subsequent readouts in major depressive disorder have been more positive, although signs of a waning effect and questions around the drug's side effects have tempered analysts' expectations.
In the postpartum depression study that read out results on Wednesday, zuranolone reduced scores on a depression rating scale called HAMD-17 more than placebo at days 3, 15, 28 and 45 of the study, meeting its primary and secondary goals.
The results also showed a statistically significant improvement on another measure that assesses depression severity.
But treatment was also associated with a number of side effects, including somnolence, dizziness and sedation. About one in four women given zuranolone experienced somnolence, according to data presented by Sage, versus 5% who received a placebo. The rate among those in the treatment group was higher than in an earlier postpartum depression study that tested a lower dose of zuranolone.
There was no evidence of withdrawal symptoms or of suicidal ideation or behavior, the companies said.
Sage already sells another drug for postpartum depression, having won the first FDA approval for the condition with its treatment Zulresso in 2019. But that drug is given as a continuous intravenous infusion over 60 hours, a barrier to access for some patients. It also carries an FDA warning for excessive sleepiness and sudden loss of consciousness.
Sales totaled $1.6 million over the first three months of the year.
While zuranolone could supplant Zulresso if approved, the companies view major depressive disorder as a bigger opportunity. They expect to complete their application to the FDA for that indication in the second half of the year.
For Biogen, the drug has become more important as the biotech has struggled to sell its new Alzheimer's disease drug Aduhelm, which was controversially approved by the FDA last year. Recently, Medicare said it would limit coverage of the drug to only patients enrolled in clinical trials, spurring Biogen to pull back marketing support for the treatment.
Biogen shares rose early on Wednesday before giving up the gains in later trading.