Significantly reduce symptoms, migraine new drug phase 3 clinical results are positive
May 04, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Allergan recently announced positive results from the ACHIEVE II (UBR-MD-02) study, the second of two key phase 3 clinical trials evaluating oral monotherapy for 25 mg and 50 mg ubrogepant for adults. The effectiveness, safety, and tolerability of migraine attacks. Allergan expects to submit a new drug application (NDA) to the FDA in 2019.
Migraine is a very common chronic disease with neurological symptoms such as headache, sensitivity to light, sound, and nausea that are usually incurable. Migraine affects about one-seventh of the world's people, causing enormous social and economic burdens. At present, there are limitations on the standard of care for acute treatment of migraine, such as limited efficacy, poor tolerance or contraindications. Patients may experience uncontrolled migraine repeatedly, leading to increased drug overuse and increased risk of disease progression. Therefore, new methods of migraine treatment are urgently needed.
Ubrogepant is a novel and potent oral calcitonin gene-related Peptide (CGRP) receptor antagonist for acute migraine treatment. CGRP and its receptor are expressed in the nervous system region associated with the pathophysiology of migraine. CGRP receptor antagonism is a new mechanism of acute treatment of migraine, which is significantly different from the existing mechanisms of triptan (serotonin 1B/1D agonist) and opioids.
The ACHIEVE II study included 1686 adult American patients who were randomized to receive a 25-mg, 50-mg ubrogepant and placebo at 1:1:1 for moderate to severe migraine attacks. In a group of 1355 modified intention-to-treat (mITT) patients, patients taking 25 mg and 50 mg of the drug had a statistically significant higher rate of pain-free after 2 hours compared with patients taking placebo (25 mg: p = 0.0285, 50 mg: p = 0.0129). In addition, after taking the 50 mg dose for 2 hours, a higher proportion of patients achieved pain relief and no migraine-related symptoms (p=0.0129). Of the 50 mg patients, more patients sustained pain relief and remained painless for 2 to 24 hours (p=0.0129). In addition, there were more 50 mg patients with no symptoms of photophobia (p=0.0167) and phobia (p=0.0440). In ACHIEVE II, ubrogepant was well tolerated and showed similar safety to placebo.
â–² Dr. David Nicholson, Chief Development Officer of Allergan (Source: Allergan Official Website)
“We are pleased to share the positive results of ACHIEVE II. Our Phase 2 Phase 3 study supports the efficacy, safety and tolerability of 50 mg ubrogepant. The consistency of ACHIEVE I and ACHIEVE II provides further evidence to support oral CGRP. The receptor antagonist ubrogepant brings hope to the acute treatment of migraine," said Dr. David Nicholson, chief development officer at Allergan. "Allergan is committed to addressing the needs of unmet migraine patients through product innovation."
“Many patients face migraine and severe disability, and ubrogepant offers new treatment options for patients who are currently tolerant of migraine-specific treatment,†said Dr. Stephen Silberstein, director of the Thomas Jefferson University Headache Center. In addition, when there are contraindications to migraine-specific drugs, medical needs still exist, and the results of ACHIEVE II will lead new treatments to improve the lives of patients."
We hope that this new migraine drug can be applied for market soon, reducing pain and improving the quality of life for the majority of migraine patients.
Reference materials:
[1] Allergan Announces Second Positive Phase 3 ClinicalTrial for Ubrogepant -- an Oral CGRP Receptor Antagonist for the AcuteTreatment of Migraine
[2] WuXi PharmaTech - treatment of migraine, the key to the new drug key phase 3 success
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