On April 25, Axsome Therapeutics revealed that chemistry, manufacturing and controls (CMS) issues were identified during the US Food and Drug Administration’s (FDA’s) review of the company’s new drug application for AXS-07 (rizatriptan and meloxicam), the company’s pipeline candidate for the acute treatment of migraine. Axsome has reported that on April 30, the Prescription Drug User Fee Act date set for AXS-07, the company expects to receive a complete response letter (CRL) from the FDA. Prior to this news, GlobalData assumed that AXS-07 would launch in Q2 2022 in the US and generate $272.7m in sales by 2030. Although Axsome has not revealed the specific problems identified by the FDA or the time required to resolve the issues, the company is scheduled to provide its first-quarter update on May 2 and may provide more information at that time.

Regardless of when and whether Axsome can adequately address the concerns raised by the FDA and AXS-07 is approved, more hurdles lie ahead for the product. 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. As both rizatriptan and meloxicam are available separately as generic drugs, KOLs worried that insurance companies would not reimburse the AXS-07 combination product, despite the Molecular Solubility Enhanced Inclusion Complex (MoSEIC) technology incorporated into the oral tablet to improve the absorption of meloxicam. Furthermore, 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 (five times the cost of taking a tablet of generic sumatriptan and a tablet of naproxen in the US) since its launch in 2008.

The acute migraine market is dominated by triptans but in the last couple of years, new drug classes, including the 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.