Biotech Values

[smallbio]

DD,

What about AXS-05 for MDD?

"Breakthrough Therapy Meeting Outcomes:

Completed ASCEND trial in MDD, now considered as pivotal, is sufficient with the ongoing STRIDE-1 trial in TRD, if positive, to support an NDA filing for AXS-05 for the treatment of MDD.

A placebo-controlled Phase 3 trial in MDD, if positive, in conjunction with the completed ASCEND trial may also support an NDA filing for AXS-05 in the treatment of MDD.

A safety database of MDD and TRD patients totaling at least 300 patients treated with AXS-05 for at least six months and at least 100 patients treated for one year is required for the NDA filing. Patients completing the ongoing STRIDE-1 and the planned placebo-controlled Phase 3 MDD trials will enter an open-label safety extension trial to build the required safety database.

A TRD indication may be supported by a placebo-controlled Phase 3 trial in TRD, if positive, in conjunction with the ongoing STRIDE-1 trial, if positive, and the completed ASCEND trial."


https://www.globenewswire.com/news-release/2019/05/06/1817271/0/en/Axsome-Therapeutics-Announces-Expedited-Development-and-Pivotal-Status-for-AXS-05-in-the-Treatment-of-Major-Depressive-Disorder-based-on-FDA-Breakthrough-Therapy-Meeting.html