Axsome Therapeutics Announces Results of MINDSET Physician Survey Affirming Unmet Need and Favorable Profile of AXS-07 in the Acute Treatment of Migraine
Majority of physicians indicate improved efficacy is most significant unmet need in the acute treatment of migraine
Majority of physicians would be more likely to prescribe AXS-07 over current and other emerging treatments if AXS-07 efficacy is confirmed in ongoing MOMENTUM Phase 3 trial
MINDSET results confirm rationale for the ongoing MOMENTUM and INTERCEPT Phase 3 trials of AXS-07
Survey physicians treat in aggregate more than 50,000 migraine patients annually
According to the vast majority of physicians (85%), the most significant unmet need in the acute treatment of migraine is efficacy, and the majority of their patients who switch acute migraine treatments (62%) do so because of suboptimal efficacy. Physicians would prescribe AXS-07 to 37% of their patients who experience difficult-to-treat migraine if it demonstrates efficacy over placebo in the ongoing MOMENTUM trial in patients with a history of inadequate response. If AXS-07 demonstrates superior efficacy to rizatriptan as assessed in the MOMENTUM trial, approximately 90% of physicians report they are more likely to prescribe AXS-07 over currently available treatments, and over other emerging therapies, including oral CGRPs, that have not demonstrated superiority to current therapies. More than half (56%) of physicians report that they are significantly or moderately more likely to prescribe AXS-07 over these other treatments. Results of the survey also indicate that treating physicians are significantly concerned that suboptimal response to acute migraine treatments may lead to progression to chronic migraine. Furthermore, the majority of physicians believe it is very important to administer acute treatments at the earliest sign of migraine pain.
“Migraine causes people to lose their jobs, lose their relationships and lose their self-identify,” said
Key Topline Findings from the
Participants and Time of Conduct
- The survey respondents consisted of a total of 106 physicians, of whom 76% are neurologists and 24% are primary care physicians. Collectively, the survey respondents personally see and treat 51,504 migraine patients at least once per year.
- The survey was fielded in
October 2019 .
Treatment Needs in Migraine
- Improved efficacy is the most significant unmet need in the acute treatment of migraine, according to 85% of physicians, far outpacing other areas (e.g. tolerability, safety, mode of administration). The majority of their patients who switch acute migraine treatments (62%) do so because of suboptimal efficacy.
- A significant number of migraine patients experience suboptimal response to current treatments or experience difficult-to-treat migraines (39% and 31%, respectively), according to treating physicians.
- Increased risk of progression from episodic to chronic migraine associated with suboptimal acute treatment is a key concern for treating physicians, with 76% reporting that they are significantly or moderately concerned.
- Early treatment of migraine (at the earliest sign of pain) is believed to be very important by 90% of treating physicians.
Willingness to Prescribe AXS-07
- If AXS-07 demonstrates superior efficacy over placebo in patients with a history of inadequate response to prior acute treatments, as assessed in the ongoing MOMENTUM trial, physicians indicate they would prescribe AXS-07 to 37% of their patients with difficult-to-treat migraines.
- If AXS-07 demonstrates superior efficacy over rizatriptan, as assessed in the ongoing MOMENTUM trial, 91% of physicians report that they are more likely to prescribe AXS-07 over currently available treatments, with 56% reporting that they are significantly or moderately more likely to prescribe AXS-07.
- If AXS-07 demonstrates superior efficacy over rizatriptan as assessed in the ongoing MOMENTUM trial, 87% of physicians report that they are more likely to prescribe AXS-07 over other drugs in development, including oral CGRPs, that have not demonstrated superior efficacy to current treatments, with 56% reporting that they are significantly or moderately more likely to prescribe AXS-07.
About the MOMENTUM Trial in Patients with History of Inadequate Response
MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) is a Phase 3, randomized, double-blind, multicenter, controlled trial to assess the efficacy and safety of AXS-07 in the acute treatment of moderate and severe migraine in patients with a history of inadequate response to prior acute treatments. Approximately 875 eligible patients will be randomized in a 2:2:2:1 ratio to treatment with AXS-07, rizatriptan, MoSEIC™ meloxicam, or placebo. The two co-primary endpoints of the trial are the proportion of patients who are free from headache pain two hours after dosing, and the proportion of patients who no longer suffer from their most bothersome migraine-associated symptom (nausea, photophobia, or phonophobia) two hours after dosing, for AXS-07 as compared to placebo. Superiority of AXS-07 to the rizatriptan and meloxicam arms (component contribution) will be established based on sustained freedom from headache pain from two to 24 hours after dosing. The MOMENTUM study is being conducted pursuant to an FDA Special Protocol Assessment (SPA).
About the INTERCEPT Trial Evaluating Early Treatment
INTERCEPT (Initiating Early Control of Migraine Pain and Associated Symptoms) is a Phase 3, randomized, double-blind, multicenter, placebo-controlled trial evaluating the early treatment of migraine with AXS-07. Approximately 300 patients will be randomized in a 1:1 ratio to treatment with AXS-07 or placebo. Patients are to administer AXS-07 at the earliest sign of migraine pain. The two co-primary endpoints of the trial are the proportion of patients who are free from headache pain two hours after dosing, and the proportion of patients who no longer suffer from their most bothersome migraine-associated symptom (nausea, photophobia, or phonophobia) two hours after dosing.
About Migraine
Over 37 million Americans suffer from migraine according to the
About AXS-07
AXS-07 is a novel, oral, investigational medicine with distinct dual mechanisms of action under development for the acute treatment of migraine. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (
About
References
1. Gooch CL, Pracht E, Borenstein AR. The burden of neurological disease in
2. Smelt AF, Louter MA, Kies DA, Blom JW, Terwindt GM, van der Heijden GJ, De Gucht V, Ferrari MD, Assendelft WJ. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One. 2014 Jun 16;9(6):e98933.
3. Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39(suppl 2):S20-S26.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain
Axsome Contact:
Senior Vice President, Operations
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
Source: Axsome Therapeutics, Inc.