Investigational Oral Migraine Treatment Closer to Full FDA Approval

The FDA has set a Prescription Drug User Fee Act target action date of April 30, 2022.

The FDA has accepted Axsome Therapeutics’ new drug application (NDA) for meloxicam-rizatriptan (AXS-07) for the treatment of acute migraine, bringing the novel investigational medication one step closer to full FDA approval.

Meloxicam-rizatriptan is a novel, oral, rapidly absorbed therapy for migraine, Axsome said in a press release. It is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence, according to the company.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2022, for the NDA.

“The FDA’s acceptance of the NDA for AXS-07 is an important milestone for Axsome as it brings us closer to potentially making this multi-mechanistic treatment available to migraine patients in need,” Herriot Tabuteau, M.D., CEO of Axsome, said in a statement.

The NDA is supported by results from two phase 3 randomized, double-blind, controlled trials that demonstrated elimination of migraine pain compared with placebo and active controls, the pharma maker said.

Migraines are common condition, with 15.3% of Americans aged 18 years or older reporting a migraine or severe headache in the previous three months, according to the CDC.

Meloxicam is a new molecular entity enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption while maintaining a long half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5-HT1B/1D agonist.

Meanwhile, OptumRx listed another investigational migraine medication, AbbVie’s ategoepant, as one of the most promising drugs in the pipeline for the third quarter of 2021. Ategoepant, expected to garner FDA approval in the third quarter, offers an additional oral treatment option for preventing migraine attacks.