No More Tears: Avanir Investors Await Trial Results on Emotional Outburst Drug

Xconomy San Diego — 

Avanir Pharmaceuticals (NASDAQ: AVNR) has been working for so long on a drug for an odd neurological syndrome that triggers involuntary laughter and tears, it’s almost enough to make some investors cry. Soon they will learn if the wait has been worth it.

In the next few weeks, the onetime San Diego biotech now just over the Orange County border in Aliso Viejo, CA, will announce results of a late-stage trial of a reformulated version of its experimental drug dextromethorphan/quinidine, or DMQ, to be marketed as Zenvia.

The drug’s original formulation reduced unwanted laughter and tears in neurological patients, but carried worrisome cardiac side effects and caused nausea and dizziness—a potential hazard in people with conditions that also affect balance, such as amyotrophic lateral sclerosis (Lou Gehrig’s disease). When the FDA raised concerns, Avanir agreed to develop and test a new version of the oral drug. That was three years ago.

“It has been a long road by our team,” CEO Keith Katkin tells me.

It could get longer still as Avanir begins to create a market for DMQ. Doctors may not recognize emotional outbursts in patients with neurological diseases or injuries as a behavioral syndrome with a potential treatment. Avanir calls the odd behaviors pseudobulbar affect, or PBA, but that name may not be familiar even to those who suffer from it. It isn’t described in the copies of the Merck Manual or Diagnostic and Statistical Manual of Mental Disorders I consulted to try to learn more about PBA. When I googled PBA, I didn’t immediately find pseudobulbar affect but pulled up numerous references to some better known PBAs, such as the Professional Bowlers Association.

Daniel Wynn, a Chicago neurologist who was involved in clinical trials for DMQ, tells me the symptoms of PBA go by different names—but the disorder is real, regardless of what it is called. He says there are parallels between PBA and overactive bladder or erectile dysfunction. There is little doubt that those conditions are real, he says, yet no one really used those terms until drugs came along to treat the disorders. Involuntary crying or laughing is distressing to patients, he says, who may withdraw from social situations or quit work because they can’t keep their reactions under wraps.

“Imagine if you shared an office with someone and you couldn’t stop crying,” Wynn says.

Still, there’s no question Avanir will need to do some serious marketing … Next Page »

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2 responses to “No More Tears: Avanir Investors Await Trial Results on Emotional Outburst Drug”

  1. Dr. Anwar says:

    Ms. Gellene should be commended for a terrific review of this company and the history of Zenvia’s development. Despite being long the stock and having followed the company for several years, I learned new information from this article.
    While the market for PBA is modest to large, the market for diabetic neuropathic pain is much larger. In my opinion as a cardiologist, the cardiac risk of QT prolongation has been essentially eliminated with the lower dose of quinidine. The questions are: A. “will the drug be effective for PBA and in the future for diabetic neuropathy?”, B. “how is the side effect profile, or how is the drug tolerated by patients?”. If the answer is yes, then the drug will generate multi-hundred million to billion (plus) dollars in sales.