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AAN 2024: new pooled data highlights efficacy of Axsome Therapeutics’s AXS-07

On 15 April, at the American Academy of Neurology (AAN) 2024, Axsome Therapeutics presented new pooled data from two Phase III trials, MOMENTUM (NCT0389600) and INTRCEPT (NCT04163185), evaluating AXS-07 (Molecular Solubility Enhanced Inclusion Complex [MoSEIC] meloxicam and rizatriptan) as an acute treatment for migraine in a poster session.

In the pooled results, 23.0% of patients receiving AXS-07 achieved headache pain freedom at two hours post-administration and 60.5% experienced pain relief at the same time point. This was significantly more than the 11.0% of patients who achieved headache pain freedom and 39.5% of patients who experienced pain relief in the placebo group during the same period. AXS-07 treatment also resulted in significantly better sustained pain relief, with 18% and 16% of patients experiencing pain freedom at 24 hours and 48 hours, respectively. This is compared with 8% and 7% of the placebo group experiencing pain freedom at the same time points. Furthermore, from one hour after administration onwards (measured up to 24 hours after administration), 66% of patients in the ASX-07 group returned to normal functioning at 24 hours compared with 47% of patients in the placebo group.

Key opinion leaders (KOLs) previously interviewed by GlobalData had mixed opinions on AXS-07. While some KOLs were keen to see the combination product as an alternative acute treatment option to triptan monotherapies, pointing out that the combination was more effective than rizatriptan monotherapy in clinical trials, other KOLs had reservations about the combination product, preferring monotherapy in their migraine treatment strategy. Some KOLs also raised concerns about the potential cost of AXS-07 in a market where multiple generic triptan monotherapy options are widely available at low costs, including rizatriptan. Furthermore, some KOLs likened AXS-07 to Currax Pharmaceuticals’s Treximet (sumatriptan/naproxen sodium). Despite being the first and only approved combination prescription medicine for migraine treatment, Treximet has seen its uptake hindered by its cost since its launch in 2008, as it is priced at five times the cost of taking a tablet of generic sumatriptan and a tablet of naproxen in the US.

In May 2022, Axsome received a complete response letter (CRL) from the FDA related to chemistry, manufacturing, and controls (CMC) considerations, which delayed the launch of the drug. The company has announced that it will resubmit a new drug application (NDA) for AXS-07 in H2 2024. If Axsome has addressed the CMC concerns, and following the positive Phase III clinical trial results, GlobalData expects that AXS-07 will be approved in the US in 2025. However, due to the significant competition in the acute migraine market from cheap generic triptans and the new class of gepants, with AbbVie’s Ubrelvy (ubrogepant), and Pzifer’s Nurtec (Rimegepant) and Zavzpret (zavegepant) all indicated in the US for acute migraine treatment with favorable efficacy profiles, it is unlikely that AXS-07 will have a significant impact on the migraine market.

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