AVP-825 was approved last January by the US Food and Drug Administration for the treatment of migraine, both with and without aura. The drug, otherwise known as ONZETRA™ Xsail™, when delivered intra-nasally, has shown increased effectiveness in treating migraine over currently available treatments.1, 2
Patients experiencing migraine frequently report dissatisfaction with their treatment, and express the wish for faster-acting medications. “Rapid and effective treatment at an early stage in an attack is vital in migraine to prevent central sensitization leading to attacks that are difficult to treat,” wrote Deborah I Friedman, MD, Professor of Neurology & Neurotherapeutics and Ophthalmology at the University of Texas Southwestern Medical Center in Dallas, Texas. “A potential weakness of oral delivery of migraine medications is the delayed or inconsistent onset of relief due to slow or erratic GI absorption.” Fast and effective pain relief from migraine may not be achieved by oral drug intake, often preferred by patients.
AVP-825 takes advantage of the body’s nasal anatomy and physiology in order to provide an efficient mode of delivery. Sumatriptan in a powder form is propelled into the upper posterior nasal cavity with the aid of the patient’s breath. From there, the drug can be rapidly absorbed with little delivery to off-target sites.
“The unique shape of the nosepiece in conjunction with the air pressure from exhalation helps to widen the nasal valve, allowing for targeted delivery to the posterior nasal cavity, and closure of the soft palate may help prevent lung deposition and limits diversion of drug into the GI tract,” wrote Dr Friedman.
Randomized, placebo-controlled studies have shown effectiveness of AVP-825 in providing fast and repeated relief from migraine, and with few adverse events usually associated with compounds of the triptan family of drugs (to which sumatriptan belongs).1, 2 Greater reduction in migraine-related pain intensity was achieved with intranasal AVP-825 than with oral sumatriptan at all time points between 15 and 90 min post-delivery.2
Other migraine-related symptoms, including photophobia and nausea were also alleviated by AVP-825, as assessed in both phase III trials.1, 2
These trials have shown efficacy of AVP-825 in relieving pain and other symptoms associated with migraine in the presence or absence of aura; additional studies seeking to determine whether it is also effective in treating cluster headaches would prove valuable.
However, the clinical trial data show that the rapid and prolonged effect of AVP-825 posit this drug as a unique treatment for migraineurs.
- Cady RK, Mcallister PJ, Spierings EL, et al. A randomized, double-blind, placebo-controlled study of breath powered nasal delivery of sumatriptan powder (AVP-825) in the treatment of acute migraine (The TARGET Study). Headache. 2015;55(1):88-100.
- Tepper SJ, Cady RK, Silberstein S, et al. AVP-825 breath-powered intranasal delivery system containing 22 mg sumatriptan powder vs 100 mg oral sumatriptan in the acute treatment of migraines (The COMPASS study): a comparative randomized clinical trial across multiple attacks. Headache. 2015;55(5):621-635.