AVP-825: a novel intranasal delivery system for low-dose sumatriptan powder in the treatment of acute migraine

ABSTRACT

Introduction: Migraine is a common, disabling disorder, and many patients remain dissatisfied with existing treatments. AVP-825 (ONZETRA® Xsail®) is a Breath Powered® exhalation delivery system for low-dose sumatriptan nasal powder (22 mg) that has been recently approved for use in the treatment of acute migraine with or without aura in adults. AVP-825 takes advantage of unique features of nasal anatomy and physiology to avoid limitations typically seen with other types of intranasal medication delivery.

Areas covered: This review provides a summary of the pharmacology, clinical efficacy and tolerability of AVP-825 in clinical studies to date and also provides an overview of the unique aspects of the delivery system.

Expert commentary: AVP-825 represents an improvement in nasal delivery of sumatriptan for migraine. PK studies indicate a distinct advantage of AVP-825 over traditional liquid nasal sprays in terms of absorption time, which may underlie the early efficacy observed with AVP-825. It offers the benefits of non-oral medications at a comparatively low sumatriptan dose, without the limitations associated with more invasive approaches. AVP-825 is suitable for use across multiple phases of a migraine attack from use as an early intervention to use in a more advanced migraine with nausea, given the non-oral application.

KEYWORDS:

• Migraine
• AVP-825
• sumatriptan
• intranasal
• ONZETRA® Xsail®
• OptiNose

Declaration of interest

S Silberstein has received honoraria as a consultant and/or advisory panel member from Alder Biopharmaceuticals; Allergan, Inc.; Amgen; Avanir Pharmaceuticals, Inc.; Curelator, Inc.; Depomed; Dr. Reddy’s Laboratories; eNeura Inc.; electroCore Medical, LLC; Lilly USA, LLC; Supernus Pharmaceuticals, Inc.; Teva Pharmaceuticals, and Trigemina, Inc. Prescott Medical Communication Group provided writing and editing assistance funded by Avanir Pharmaceuticals, Inc. in the production of this manuscript.

Additional information

Funding

This manuscript was sponsored by Avanir Pharmaceuticals Inc.