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Sage and Biogen Report One-Year Results of Zuranolone in the P-III (SHORELINE) Study for the MDD

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Sage and Biogen Report One-Year Results of Zuranolone in the P-III (SHORELINE) Study for the MDD

Shots:

  • The ongoing P-III (SHORELINE) study evaluates zuranolone (50mg, qhs for 14 days) in 199 patients with MDD for ~1yrs.
  • The results showed rapid & sustained improvements in depressive symptoms, 40.7% of patients were on pre-existing ADT while 59.3% were not on ADT, 68.8% of patients has one AEs similar to the previously reported 30mg cohort (68.0%), The therapy was well-tolerated & no new safety finding or trend was observed, treatment discontinuation and withdrawal due to TEAEs (6.5% & 8.0%)
  • Additionally, 74.9% of patients achieved response during an initial 2wks. treatment with 50% reduction from baseline and 40.2% achieved remission (HAMD ≤7), 80% received 1 or 2 treatment courses

/ article | Ref: Businesswire | Image: Biogen

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