AXS-07 Meets Primary End Points, Halts Migraine Pain Progression

April 8, 2020

Phase 3 INTERCEPT data suggest the agent is successful in migraine treatment, and an NDA submission of AXS-07 in the acute treatment of migraine is on track for Q4 2020.

Herriot Tabuteau, MD

Axsome Therapeutics announced its novel, oral, investigational medicine, AXS-07, met co-primary end points, as well as showed substantial and significant elimination of migraine pain and prevented progression of migraine pain intensity in the INTERCEPT phase 3 trial (NCT04163185).1

In INTERCEPT , the co-primary end points were pain freedom and freedom from the most bothersome symptom. There were a statistically significantly greater percentage of patients achieving pain freedom compared to placebo (32.6% versus 16.3%, respectively; P = .002), as well as freedom from the most bothersome symptom (43.9% versus 26.7%, respectively; P = .003), 2 hours after dosing.

In addition to meeting the primary end points, the agent showed efficacy in preventing progression of migraine pain beyond mild intensity while significantly reducing the use of rescue medication. Between 2 and 24 hours after dosing, freedom of pain progression occurred in 73.5% of AXS-07 patients compared with 47.4% of placebo patients (P <.001).

“We are very pleased with the strong results of the phase 3 INTERCEPT trial, which confirm the superior and durable efficacy of AXS-07. The prevention of migraine pain progression, and the substantial increase in the rate of pain freedom demonstrated with early treatment with AXS-07, expand and enhance its differentiated profile for the acute treatment of migraine,” Herriot Tabuteau, MD, chief executive officer, Axsome, said in a statement.

In January of this year, Axsome released data stemming from its phase 3 MOMENTUM trial, in which AXS-07 also achieved both primary end points of pain freedom (P <.001) and freedom from most bothersome symptom (P = .002), as well as an additional key secondary endpoint of superiority in pain-freedom over an active comparator, rizatriptan (P = .038).2

AXS-07’s formulation consists of both MoSEIC meloxicam and rizatriptan and it is administered in tablet form to provide an enhanced rate of absorption of meloxicam.

INTERCEPT was a double-blind, placebo-controlled trial that included 302 patients randomized 1:1 to treat a single migraine attack with a single dose of AXS-07 (20 mg meloxicam/10 mg rizatriptan), or placebo, at the earliest sign of migraine pain, while the pain intensity was mild. Primary outcome measures observed included percentage of patients reporting headache pain freedom at 2 hours and percentage of patients with absence of most bothersome symptoms.

As previously mentioned, the drug showed significant results on both co-primary end points but was also numerically superior to placebo in a multitude of other end points. Pain freedom and most bothersome symptom freedom was achieved as early as 30 minutes in patients who received AXS-07. Additionally, the drug achieved statistical significance for migraine pain freedom at 90 minutes (P = .003) and at every time point after.

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Sustained pain freedom from 2 to 24 hours after dosing was experienced by 22.7% and 12.6% of patients treated with AXS-07 and placebo, respectively (P = .030). Similar sustained pain freedom from 2 to 48 hours after dosing was seen in both AXS-07 and placebo patients as well (20.5% vs 9.6%; P = .013).

While the drug prevented progression of migraine pain intensity, rescue medication was used by 15.3% of AXS-07 patients compared to 42.2% of placebo patients over 24 hours (P <.001).

Researchers observed functional and global improvement as well, noting that 52.4% of AXS-07 patients were very much or much improved compared to 27.7% of placebo patients (P <.001) on the Patient Global Impression of Change (PGI-C) scale.

The drug was generally safe and well tolerated with no reports of serious adverse events (AEs) throughout the trial. Somnolence, dizziness and paresthesia, all of which occurred in less than 5%, were among the most commonly reported AEs.

“These results, coupled with previous clinical data showing superiority of AXS-07 over an active comparator, provide clinical evidence that this synergistic, multi-mechanistic approach and the rapid absorption of AXS-07 may translate to important benefits for a wide range of patients,” Stewart Tepper, MD, professor of neurology, Geisel School of Medicine, Dartmouth University, said in a statement. “As clinicians continue to seek options for their patients with improved efficacy over currently available therapies, AXS-07 may offer an important new treatment for this disabling condition.”

Axsome also announced that a new drug application (NDA) for AXS-07 in the acute treatment of migraine is on track for Q4 2020.

REFERENCES

1. Axsome Therapeutics announces AXS-07 achieves both co-primary endpoints and prevents migraine pain progression in the INTERCEPT phase 3 trial in the early treatment of migraine [news release]. New York, NY: Axsome Therapeutics. April 6, 2020. Accessed April 7, 2020. finance.yahoo.com/news/axsome-therapeutics-announces-axs-07-100010869.html

2. Axsome Therapeutics Announces AXS-07 Achieves Co-Primary and Key Secondary Endpoints in MOMENTUM Phase 3 Migraine Trial in Patients with History of Inadequate Response [press release]. New York, NY: Axsome Therapeutics; Published December 30, 2019. Accessed April 8, 2020. biospace.com/article/releases/axsome-therapeutics-announces-axs-07-achieves-co-primary-and-key-secondary-endpoints-in-momentum-phase-3-migraine-trial-in-patients-with-history-of-inadequate-response