Following a poster presentation at the American Academy of Neurology (AAN) 2024 annual meeting of new pooled data from two Phase III trials, MOMENTUM (NCT0389600) and INTRCEPT (NCT04163185), evaluating Axsome Therapeutics’s AXS-07 (MoSEIC™ meloxicam and rizatriptan) as a novel acute combination treatment for migraine;

Philippa Salter, Senior Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“Although the migraine market is saturated with acute treatments, the key opinion leaders (KOLs) interviewed by GlobalData welcomed the combination product as an alternative acute treatment option, pointing out that the combination was more effective that rizatriptan monotherapy in clinical trials.

“However, other KOLs had reservations about the combination product preferring monotherapy in their migraine treatment strategy. Some KOLs also raised concerns around the potential high cost of AXS-07 in a market where there are multiple triptan therapies with wide cheap, generic availability, including rizatriptan.

“Further, some KOLs likened AXS-07 to Currax Pharmaceuticals’s Treximet, a combination tablet containing sumatriptan and naproxen which, despite being the first and only approved combination prescription medicine for migraine treatment, has seen its uptake hindered by its cost (five times the cost of taking a tablet of generic sumatriptan and a tablet of naproxen in the US) since its launch in 2008.

“Axsome Therapeutics is expecting to resubmit a new drug application (NDA) for ASX-07 in H2 2024 following a complete response letter received from the FDA in May 2022. However, due to the significant competition in the acute migraine market, not only from generic triptans but also from the new class of gepants, with AbbVie’s Ubrelvy (ubrogepant), and Pzifer’s Nurtec (Rimegepant) and Zavzpret (zavegepant) all approved in the US for acute migraine treatment, it is unlikely that AXS-07 will have a large impact in the migraine market.”