Parth Patel's questions to Axsome Therapeutics Inc (AXSM) leadership • Q1 2025
Question
Parth Patel, on behalf of Vikram Purohit from Morgan Stanley, asked about the intended design of the upcoming Phase III trial for solriamfetol in MDD with EDS, including study size and key endpoints, and whether this would be the sole additional trial required for a potential filing.
Answer
Herriot Tabuteau, CEO, responded that specific study designs are disclosed upon trial launch. He noted that the design will incorporate learnings from the recently completed proof-of-concept study. He highlighted that the target population of MDD with excessive sleepiness represents about 50% of all MDD patients but did not specify if this would be the only trial needed for approval.