AXS-05 Path to Approval for MDD

• Axsome Therapeutics met with the FDA and was given an expedited pathway of AXS-05 for Major Depressive Disorder or MDD. Under this new agreement, the company's phase 2 clinical trial known as Ascend for MDD was given pivotal status, and will only need one other pivotal phase 3 with efficacy, to file a New Drug Application (NDA).
• The company plans to enroll for a new phase 3 placebo clinical trial in the 2nd quarter of 2019, with an expected completion date by the end of 2019. The company plans on initiating this phase 3 with an increased number of clinical sites recruiting participants, which will allow for completion faster over the successfully completed phase 2 Ascend clinical trial for MDD.
• The timeline for filing an NDA would then be in the first half of 2020. If this timeline holds up, AXS-05 could potentially get to commercialization around the same time as Sage Therapeutics drug SAGE-217, which is also pursuing the same MDD indication.

AXS-05 was given Breakthrough Therapy Designation (BTD) from the FDA for Major Depressive Disorder, and the patent extends out to 2034. Thank you for reading.