Hurdles for Axsome's migraine treatment AXS-07 beyond FDA approval, says analyst

Central nervous system (CNS) specialist Axsome Therapeutics (Nasdaq: AXSM) expects to receive a complete response letter (CRL) from the FDA due to the recently revealed chemistry, manufacturing, and control (CMS) issues identified during the FDA’s review of its new drug application for AXS-07 (rizatriptan and meloxicam), for the acute treatment of migraines.

According to sector analytics firm GlobalData’s report,  ‘Migraine Drug Market Size, Share & Trends Analysis and Forecast by Strategic Competitor Assessment, Market Characterization, Unmet Needs, Clinical Trial Mapping and Implications 2020 – 2030’, prior to this news, it was assumed that AXS-07 would launch in the second half of 2022 in the USA and generate $272.7 million in sales by 2030. Depending on whether this delays the launch by three months or a full year, this could mean diminished 2030 forecast sales by $3 to $10 million. However, GlobalData believes that more hurdles lie ahead for the product regardless of when and whether these concerns can be adequately addressed.

Pharma analyst Christie Wong comments: “For the past two decades, oral triptans have been considered the industry gold standard to abort migraine headaches. Axsome Therapeutics is attempting to enter a highly crowded market space with a single pill that combines a triptan and a non-steroidal anti-inflammatory drug.”