- April 28, 2018
- Posted by: PharmaScroll
- Category:
Allergan plc, a leading global pharmaceutical company announced positive results from ACHIEVE II (UBR-MD-02), the second of two pivotal Phase 3 clinical trials evaluating the efficacy, safety and tolerability of orally administered ubrogepant 25 mg and ubrogepant 50 mg compared to placebo in a single migraine attack in adults. Allergan anticipates filing of a New Drug Application (NDA) to the FDA in 2019.
The ACHIEVE II study included 1,686 U.S. adult patients randomized (1:1:1) to placebo, ubrogepant 25 mg and 50 mg respectively, to treat a single migraine attack of moderate-to-severe headache intensity.
In the modified ITT (mITT) population of 1355 patients, both doses showed a statistically significant greater percentage of ubrogepant patients achieving pain freedom at 2 hours after the initial dose as compared to placebo patients (25 mg vs placebo, p=0.0285, 50 mg vs placebo, p=0.0129) and the 50 mg dose demonstrated a statistically significant greater percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose as compared to placebo patients (50 mg vs placebo, p=0.0129). The 25 mg dose demonstrated improvement in the percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose as compared to placebo patients, however failed to demonstrate statistical significance (25 mg vs placebo, p=0.0711). (See Table)
The 50 mg dose of ubrogepant also showed a statistically significant greater percentage of patients achieving pain relief at 2 hours, sustained pain relief from 2-24 hours, and sustained pain freedom from 2-24 hours after the initial dose as compared to placebo (50 mg vs placebo, p=0.0129 for each of these endpoints). In addition, ubrogepant 50 mg also showed a statistically significant greater percentage of patients achieving absence of photophobia (p= 0.0167) and phonophobia (p= 0.0440) at 2 hours after the initial dose as compared to placebo. Ubrogepant 25 mg compared to placebo failed to demonstrate statistical significance in these endpoints.
“We are pleased to share these positive results from ACHIEVE II, our second Phase 3 study supporting the efficacy, safety, and tolerability of 50 mg ubrogepant. The consistency in response between both ACHIEVE I and ACHIEVE II provides further evidence that ubrogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, offers a promising opportunity for the acute treatment of migraine”, said David Nicholson, Chief Research and Development Officer, Allergan. “Allergan is committed to addressing unmet patient needs through product innovation and has identified a clear need in the migraine marketplace.”
In ACHIEVE II, ubrogepant was well tolerated and demonstrated a safety profile similar to placebo. There was no signal of hepatotoxicity for ubrogepant. The most common adverse events were nausea and dizziness, neither of which was reported with a frequency >2.5%. In terms of hepatic safety within 30 days of dosing, there were 4 cases (1 in placebo and 3 in ubrogepant arms) with aminotransferase (ALT or AST) elevations greater than 3 times (but not higher than 5 times) the upper limit of normal (ULN). Each of these 4 cases were adjudicated by a blinded panel of liver experts and none were noted by the liver safety adjudication board to have a probable relationship to ubrogepant. Of these 4 cases, one case was noted within 7 days of drug administration (attributed to exercise-induced rhabdomyolysis, on 50 mg ubrogepant and again, noted by the liver safety adjudication board to not have a probable relationship to ubrogepant). There were no cases of Hy’s Law.
“Given the prevalence of migraine and significant disability that many patients face, ubrogepant may provide a new option for those having tolerability issues with current migraine-specific treatments.” said Dr. Stephen Silberstein, Director, Headache Center, Thomas Jefferson University. “In addition, a need exists for treatments when there is a contraindication to migraine-specific medications. Results from ACHIEVE II will lead to a new treatment that will improve the lives of patients.”
Additional results from this study are anticipated to be released at upcoming scientific meetings throughout 2018.
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News Source: Allergan Website
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