We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Axsome's (AXSM) Migraine Drug Meets Goals in Late-Stage Study
Read MoreHide Full Article
Axsome Therapeutics, Inc. (AXSM - Free Report) announced that its novel, oral, multi-mechanistic investigational candidate, AXS-07, met the two regulatory co-primary endpoints in a late-stage study.
The phase III MOMENTUM study was a randomized, double-blind, placebo- and active-controlled trial, which enrolled only patients with a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4). The study was conducted pursuant to an FDA Special Protocol Assessment (SPA).
A total of 1,594 patients were randomized in a 2:2:2:1 ratio to AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan), Maxalt, MoSEIC meloxicam (20 mg), or placebo, to treat a single migraine attack of moderate or severe intensity. Additionally, the enrolled patients exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes, including cutaneous allodynia (75.4%), severe migraine pain intensity (41.2%), obesity (43.7%) and morning migraine (36.6%).
Maxalt (rizatriptan), an active comparator in the trial, is considered to be the fastest acting oral triptan and one of the most effective medications currently available for the acute treatment of migraine.
Results showed that AXS-07 met the two regulatory, co-primary endpoints and significantly improved migraine pain and most trouble symptoms as compared to placebo. The candidate also met the key secondary endpoint, demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom from migraine pain. A greater percentage of patients achieved pain freedom and absence of most bothersome symptom with AXS-07 after two hours of dosing as compared to placebo. The candidate was safe and well tolerated in the trial.
Hence, the positive results on both co-primary endpoints along with the demonstration of component contribution support the filing of an NDA for AXS-07 in the acute treatment of migraine. Per its discussions with the FDA, Axsome believes that MOMENTUM will be the only efficacy study required to support an NDA filing for the same. The company plans to file the NDA in the second half of 2020.
The successful development and commercialization of the candidate will be a significant boost for this clinical-stage biopharmaceutical company. AXS-07 is currently in two phase III studies for the same indication.
The company’s shares have skyrocketed 3581.9% in the past year compared with the industry’s growth of 7.7%.
Axsome is developing novel therapies for the management of central nervous system (CNS) disorders, for which there are limited treatment options. Apart from ASX-07, the company’s core CNS product portfolio includes three clinical-stage candidates — AXS-05, AXS-09 and AXS-12. AXS-05 is currently in a phase III study for treatment resistant depression (TRD), a phase II/III study in agitation associated with Alzheimer’s disease (AD). AXS-05 is also being developed for smoking cessation treatment and for major depressive disorder (MDD). AXS-12 is being developed for the treatment of narcolepsy.
The FDA recently approved Allergan’s Ubrelvy (ubrogepant) for the acute treatment of migraine with or without aura in adults. Other approved drugs include Eli Lilly’s (LLY - Free Report) Emgality and Teva Pharma’s (TEVA - Free Report) Ajovy.
Would you like to see the updated picks from our best market-beating strategies? From 2017 through Q3 2019, while the S&P 500 gained +39.6%, five of our strategies returned +51.8%, +57.5%, +96.9%, +119.0%, and even +158.9%.
This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
Image: Bigstock
Axsome's (AXSM) Migraine Drug Meets Goals in Late-Stage Study
Axsome Therapeutics, Inc. (AXSM - Free Report) announced that its novel, oral, multi-mechanistic investigational candidate, AXS-07, met the two regulatory co-primary endpoints in a late-stage study.
The phase III MOMENTUM study was a randomized, double-blind, placebo- and active-controlled trial, which enrolled only patients with a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4). The study was conducted pursuant to an FDA Special Protocol Assessment (SPA).
A total of 1,594 patients were randomized in a 2:2:2:1 ratio to AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan), Maxalt, MoSEIC meloxicam (20 mg), or placebo, to treat a single migraine attack of moderate or severe intensity. Additionally, the enrolled patients exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes, including cutaneous allodynia (75.4%), severe migraine pain intensity (41.2%), obesity (43.7%) and morning migraine (36.6%).
Maxalt (rizatriptan), an active comparator in the trial, is considered to be the fastest acting oral triptan and one of the most effective medications currently available for the acute treatment of migraine.
Results showed that AXS-07 met the two regulatory, co-primary endpoints and significantly improved migraine pain and most trouble symptoms as compared to placebo. The candidate also met the key secondary endpoint, demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom from migraine pain. A greater percentage of patients achieved pain freedom and absence of most bothersome symptom with AXS-07 after two hours of dosing as compared to placebo. The candidate was safe and well tolerated in the trial.
Hence, the positive results on both co-primary endpoints along with the demonstration of component contribution support the filing of an NDA for AXS-07 in the acute treatment of migraine. Per its discussions with the FDA, Axsome believes that MOMENTUM will be the only efficacy study required to support an NDA filing for the same. The company plans to file the NDA in the second half of 2020.
The successful development and commercialization of the candidate will be a significant boost for this clinical-stage biopharmaceutical company. AXS-07 is currently in two phase III studies for the same indication.
The company’s shares have skyrocketed 3581.9% in the past year compared with the industry’s growth of 7.7%.
Axsome is developing novel therapies for the management of central nervous system (CNS) disorders, for which there are limited treatment options. Apart from ASX-07, the company’s core CNS product portfolio includes three clinical-stage candidates — AXS-05, AXS-09 and AXS-12. AXS-05 is currently in a phase III study for treatment resistant depression (TRD), a phase II/III study in agitation associated with Alzheimer’s disease (AD). AXS-05 is also being developed for smoking cessation treatment and for major depressive disorder (MDD). AXS-12 is being developed for the treatment of narcolepsy.
The FDA recently approved Allergan’s Ubrelvy (ubrogepant) for the acute treatment of migraine with or without aura in adults. Other approved drugs include Eli Lilly’s (LLY - Free Report) Emgality and Teva Pharma’s (TEVA - Free Report) Ajovy.
Axsome currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through Q3 2019, while the S&P 500 gained +39.6%, five of our strategies returned +51.8%, +57.5%, +96.9%, +119.0%, and even +158.9%.
This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
See their latest picks free >>