Axsome Therapeutics 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 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 Q2 2022 in the US 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.

Christie Wong, Pharma Analyst at GlobalData 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.”

While key opinion leaders (KOLs) previously interviewed by GlobalData were impressed by the efficacy data for AXS-07, they were concerned regarding the anticipated annual cost of therapy associated with the product. GlobalData estimates that AXS-07’s annual cost of therapy will be approximately $2,170, at a 90% premium to Merck’s Maxalt (rizatriptan).  As both rizatriptan and meloxicam are available separately as generic drugs, KOLs worried that insurance companies would not reimburse the AXS-07 combination product. Thus, limiting patients’ access to AXS-07.

Some KOLs likened AXS-07 to Currax Pharmaceuticals’ Treximet, a combination tablet containing sumatriptan and naproxen; despite being the first and only approved combination prescription medicine for migraine treatment, the uptake of Treximet has been hindered by its cost since its launch in 2008. Treximet is five times the cost of taking a tablet of generic sumatriptan and a tablet of naproxen in the US and at a 90% premium of GlaxoSmithKline’s Imitrex (sumatriptan). As such, if approved, AXS-07 could face a similar issue with uptake.

Wong concludes: “The acute migraine market is dominated by triptans but in the last couple of years, new drug classes including ditans and gepants have entered the market. Thus, should AXS-07 eventually receive FDA approval, Axsome Therapeutics needs to provide strong efficacy data and solid marketing to set it apart from competitors in a crowded market and convince payers to reimburse it.”