The Centers for Disease Control and Prevention estimates there are 37 million migraine sufferers in the U.S., and that roughly 13 million prescriptions are written annually for triptan medicines to treat those people. But there's a big problem: too many patients think their migraine therapy falls short.
Why migraine treatment fails isn't adequately understood. Migraines can be unpredictable, and their triggers can range from scents to changes in the weather. However, bioiotechnology company Avanir (UNKNOWN:AVNR.DL) thinks it might have developed an improved formulation of a widely used migraine drug. If so, patients could soon have a new weapon to use against their migraine.
A square wheel might get you where you're going, but it won't work well
Triptans have been prescribed to migraine patients for decades, and sumatriptan accounts for about half of the prescriptions written for migraines every year. Widespread use, though, does not mean sumatriptan is a perfect drug. Sumatriptan comes with potentially onerous side effects and risks, including heart disease, that make it far from ideal.
That got Avanir to thinking: If it could develop a better version of sumatriptan, wouldn't doctors and patients use it instead? Probably, but what would a better drug look like?
Since a migraine can be unpredictable and quickly debilitating, a new drug would need to work more quickly. And since triptans pose safety risks that can eventually turn life-threatening, a new formulation should also offer a better safety profile.
Creating such a drug, even when reimagining an existing therapy, is no easy feat. The cost to develop a new medicine can run into the hundreds of millions of dollars, and the vast majority of researchers' efforts never get beyond the laboratory.
Avanir will find out soon whether AVP-825, a unique formulation of sumatriptan that worked better than sumatriptan in clinical trials, overcame those obstacles.
AVP-825 is a new 22-milligram, low-dose formulation of sumatriptan that is taken intranasally, rather than swallowed. Since the dose is delivered via breath inhalation, AVP-825 patients reported that they experience greater pain relief within a half hour than patients taking original 100-mg sumatriptan tablets. AVP-825 patients also reported greater pain relief than sumatriptan tablet patients at 15-minute intervals up to 90 minutes.
Importantly, since AVP-825 is a much lower dose than sumatriptan tablets,few adverse events were reported during clinical studies; most were mild, which could suggest a more favorable safety profile.
If the Food and Drug Administration gives Avanir the green light on its new product, the company thinks AVP-825 could generate between $150 million and $200 million a year in sales. According to Avanir, the market for triptans is worth more than $5.8 billion annually, which means that even at a 1% market share, AVP-825 could still produce meaningful sales of nearly $60 million per year. Those numbers might not be unreasonable given that sumatriptan earned GlaxoSmithKline (NYSE:GSK) $1 billion per year prior to its loss of patent protection; another GlaxoSmithKline formulation of sumatriptan, sold as Treximet, had sales of nearly $80 million in 2013.
Building a bigger company
Avanir today sells one commercial drug, Nuedexta, which is enjoying rapid sales growth. Nuedexta won FDA approval in 2010 as a treatment for pseudobulbar affect, and sales eclipsed the $100 million annualized run rate in the fiscal third quarter of 2014.
If Avanir wins FDA approval for AVP-825, it could have two drugs with nine-figure sales potential; if so, revenue from Nuedexta and AVP-825 could go a long way toward supporting Avanir's ongoing midstage studies on drugs for the treatment of agitation and dyskinesia in Alzheimer's patients, as well as major depressive disorder. Regardless, since 79% of migraine patients say they would try a new treatment, doctors and patients will likely applaud if the FDA approves AVP-825 on Nov. 26.