康涅狄格州新罕布什尔, 2018年12月3日，美通社——Biohaven药业控股有限公司（纽约证券交易所证券代码：BHVN）今天宣布了一项随机化、具可控性的III期临床试验（研究代号：BHV3000-303或Study 303）的积极统计结果，验证了口服降钙素基因相关肽（CGRP）受体 rimegepant Zydis®的口腔溶解片（ODT）制剂用于偏头痛急性治疗的有效性和安全性。与之前的两期临床试验结果一致，Study 303研究结果表明，该制剂在单次给药的2小时内有效缓解疼痛及最困扰症状（MBS）。重要的是，服用该制剂治疗的患者在给药后15分钟疼痛就开始得到缓解，在数据上与安慰剂给药组差异较大。
– Single dose, proprietary, rimegepant Zydis ODT formulation provided rapid onset of pain relief with numerical separation from placebo as early as 15 minutes and statistically significant by 60 minutes
– Achieved statistical significance on regulatory co-primary endpoints of pain freedom (p < 0.0001) and freedom from most bothersome symptom (p = 0.0009) at 2 hours
– Novel Zydis ODT formulation demonstrated superiority over placebo in 21 consecutive, prespecified, hierarchically-tested efficacy outcome measures
– Differentiated efficacy and safety profile with rimegepant in all three pivotal Phase 3 trials provides robust support for planned new drug application submission in the first half of 2019
NEW HAVEN, Conn., Dec. 3, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced positive topline results from a randomized, controlled Phase 3 clinical trial (BHV3000-303 or Study 303) evaluating the efficacy and safety of its Zydis® orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine. In Study 303, rimegepant Zydis ODT statistically differentiated from placebo on the two co-primary endpoints as well as the first 21 consecutive primary and secondary outcome measures that were prespecified in hierarchical testing. Consistent with the two previous Phase 3 clinical trials, Study 303 met its co-primary registrational endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2 hours using a single dose (Table 1). Importantly, patients treated with the rimegepant Zydis ODT formulation began to numerically separate from placebo on pain relief as early as 15 minutes, and this difference was statistically significant at 60 minutes (p < 0.0001) (Figure 1). Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60 minutes as compared to placebo (p = 0.0025). Lasting clinical benefit was observed through 48 hours after a single dose of rimegepant on freedom from pain (p < 0.0001), pain relief (p < 0.0001), freedom from the most bothersome symptom (p = 0.0018), and freedom from functional disability (p < 0.0001). Superiority over placebo was also demonstrated in multiple other secondary endpoints. The vast majority of patients treated with rimegepant Zydis ODT (85%) did not use any rescue medications.
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