Zuranolone meets late-stage and secondary goals on study for participants with MDD.
On Wednesday, Sage Therapeutics announced that their antidepressant drug zuranolone, improved depressive symptoms after three days. The success of the drug in the late-stage study has resulted in the biopharmaceutical company submitting their data for FDA approval. Sage and partner Biogen noted that the drug has statistically fulfilled the study’s secondary goal of improving symptoms over a two-week timespan. Despite the drugs success, the company’s shares dropped by 10% to $39 prior to the bell due to investor concerns over how long the treatment’s effect would last. Joon Lee, Truist Securities analyst stated, "The clinical benefit is modest and the effects are not durable." Lee added that the regulatory approval process will likely be "wrought with noise, controversy" over the next 12-18 months.
Four hundred and forty participants with major depressive disorder (MDD) were involved in the study, zuranolone administered along with antidepressants resulted in a reduction in anxiety and sadness, as compared to the placebo and antidepressants combination. Jeff Jonas, chief innovation officer at Sage Therapeutics stated, "What this study has done, we believe, is just substantiated that zuranolone could be a unique treatment option for patients." MDD is a medical illness where people experience depressive symptoms and affects over 16 million adults in America every year. MDD is treated with antidepressants which take up to six weeks to show effect. The biopharmaceutical company aims to start the submission of data FDA approval of zuranolone for MDD early this year and planning on completing the application by the second half of 2022.