期刊
EXPERT OPINION ON DRUG DELIVERY
卷 12, 期 9, 页码 1565-1577出版社
TAYLOR & FRANCIS LTD
DOI: 10.1517/17425247.2015.1060959
关键词
AVP-825; intranasal; migraine; sumatriptan
资金
- Avanir Pharmaceuticals, Inc., Aliso Viejo, CA
- Alder
- Amgen
- Allergan Inc.
- Avanir Pharmaceuticals, Inc.
- Electrocore
- Labrys
- Tian Medical
- Fortis Spectrum
- GlaxoSmithKline plc.
- Questcor Pharmaceuticals
- Primary Care Education
- Avanir Pharmaceuticals
Introduction: AVP-825, formerly 'OptiNose Sumatriptan,' is an investigational BreathPowered (TM) BiDirectional (TM) intranasal delivery system containing low-dose sumatriptan (22 mg intranasal powder) that avoids limitations of other types of intranasal administration by taking advantage of unique features of nasal anatomy and physiology. Areas covered: This review summarizes intranasal drug delivery for migraine, how the breath-powered technology works, and AVP-825 pharmacokinetic, efficacy and safety/tolerability findings. To identify AVP-825 clinical studies, a PubMed/MEDLINE database search was conducted with the terms AVP-825, OptiNose, OptiNose Sumatriptan, Breath-Powered Nasal Delivery or sumatriptan powder. Of 20 articles, 5 clinical studies were identified, including the head-to-head comparative COMPASS trial (AVP-825 vs oral sumatriptan) and two placebo-controlled studies. Expert opinion: AVP-825 has faster sumatriptan absorption versus oral tablets or traditional liquid nasal spray. In Phase II/III randomized, double-blind, placebo-controlled trials, AVP-825 produced early and sustained efficacy with minimal triptan-related adverse effects. In COMPASS, AVP-825 produced earlier reduction of migraine pain intensity and migraine-associated symptoms than 100 mg oral sumatriptan, and higher early rates of pain relief and pain freedom, similar sustained efficacy, and fewer atypical sensations. AVP-825 has the potential to provide migraine patients with improved intranasal administration of sumatriptan that may enhance efficacy and tolerability.
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