title: A novel intranasal breath-powered delivery system for sumatriptan: a review of technology and clinical application of the investigational product AVP-825 in the treatment of migraine.
abstract: BACKGROUND
  AVP-825, formerly 'OptiNose Sumatriptan,' is an investigational Breath-Powered(TM) Bi-Directional(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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Headache Care Center , 3805 S. Kansas Expressway, Ste. B, Springfield, MO 65807 , USA +1 417 841 3615 ; +1 417 886 4498 ; rcady@headachecare.com.
authors.forename: Roger
authors.initials: R
authors.lastname: Cady
mesh_terms: D000281:Administration, Intranasal; D016503:Drug Delivery Systems; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy*; D009666:Nose; D011208:Powders / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D018170:Sumatriptan / Q000008:administration & dosage*
chemical_list: D011208:Powders; D018170:Sumatriptan
keywords: AVP-825; intranasal; migraine; sumatriptan