This Is MS - Excessive Emotions Drug Neurodex Successful in Phase III Trial | Unbiased Multiple Sclerosis Research, News, and Community

Yesterday Avanir announced that their drug Neurodex showed positive results in its final clinical trials. Neurodex will be used for controlling the Pseudo-Bulbar Effect, which is characterized by excessive emotions (emotional lability) such as laughing or crying uncontrollably. This condition affects a segment of the MS population, and if approved, will be the first treatment specifically targeted for this condition (currently doctors prescribe general antidepressants to patients exhibiting symptoms of emotional lability).

While it would of course be better to treat the cause of this rather than control the symptoms, it is a step in the right direction. The company will file for final approval with the FDA by the end of the year.

"...In the latest Phase 3 clinical trial, patients with multiple sclerosis who received Neurodex had a statistically significant reduction in the frequency and severity of emotional outbursts compared with those who received a placebo. Those who received the drug also experienced a better quality of life and pain reduction, the company said. Side effects included dizziness..."

Click "read more" for the full story...

Full Article Text

Drug trial results are favorable, Avanir says
By Pennie Crabtree
Union-Tribune Staff Writer

August 25, 2004

Avanir Pharmaceuticals yesterday reported positive results in a pivotal human test of an experimental drug to treat an embarrassing symptom of some neurologic disorders: uncontrolled laughter or crying.

The San Diego biotechnology company said it will file with federal regulators by the end of the year to seek approval for the drug, called Neurodex, to treat an obscure condition known as pseudobulbar affect, or PBA.

If approved, Neurodex would be the second product to make it to market for Avanir and potentially the first to generate significant revenue for the company. Most of the profits from Avanir's first product, an over-the-counter cold sore medicine, go to the company's marketing partner, GlaxoSmithKline.

Shares of Avanir rose nearly 18 percent, or 34 cents, to close at $2.24.

In the latest Phase 3 clinical trial, patients with multiple sclerosis who received Neurodex had a statistically significant reduction in the frequency and severity of emotional outbursts compared with those who received a placebo. Those who received the drug also experienced a better quality of life and pain reduction, the company said. Side effects included dizziness.

The favorable results largely mirror those of an earlier Neurodex study in patients with Lou Gehrig's disease, according to the company.

Gerald Yakatan, chief executive of Avanir, delivered a jubilant assessment of the drug's performance during a conference call with Wall Street analysts.

"I've been in this business for more than 30 years and involved in a lot of clinical trials, and the replication we've seen in these two studies – the simularity of the data and the quality of the data – are exceptional," Yakatan said. "We couldn't have made the data up any better than what we've been able to achieve in this trial."

Avanir's treatment for PBA is a patented combination of two already approved drugs: dextromethorphan, a common ingredient used in cough remedies, and quinidine, a drug that slows down the metabolism of dextromethorphan by the liver so the drug stays in the body longer.

The company believes Neurodex could have broad treatment potential. An estimated 10 percent to 50 percent of patients with multiple sclerosis, Lou Gehrig's disease, Alzheimer's disease, stroke and traumatic brain injury suffer from the emotional condition, the company said.

Swayampakula Ramakanth, an analyst with Rodman & Renshaw, was bullish yesterday about Neurodex and pegged its chances of regulatory approval at 90 percent.

Risks that the drug won't be approved include the measures by which Neurodex's benefits were measured, according to Rodman & Renshaw. Avanir scored a checklist of self-reported measurements designed by Dr. Richard Alan Smith, who invented the drug. The measurements, though published in a scientific journal, have not been used in any other clinical trial to determine a drug's benefit.

Currently, patients with PBA are treated with antidepressants. If approved, Neurodex would be the first drug specifically designed to treat the condition.

"We believe it (Neurodex) has a better safety profile than antidepressants that are currently being used," Ramakanth said yesterday in a research note. "Assuming a 20 percent market penetration and pricing comparable to antidepressants, the peak U.S. market for Neurodex in PBA is approximately $300 million to $1.2 billion."

Smith, the San Diego neurologist who developed and patented the formula for Neurodex, said PBA can have a devastating effect on patients and their families.

"It's hard to function as an adult when you can't control basic emotions," said Smith, director of the nonprofit Center for Neurological Study in La Jolla. "My personal belief is this drug has benefits that will ultimately make it the drug of choice in a number of instances."

Smith said the Center for Neurological Study licensed Neurodex in 1997 to San Diego's IriSys Research and Development, a private company whose founder and majority shareholder is Yakatan, the Avanir CEO.

IriSys sublicensed the rights to Neurodex to Avanir in 2000, two years after Yakatan became Avanir's CEO. Avanir has not disclosed how much it will have to pay in royalties on Neurodex to IriSys or the center if the drug is approved.

Rodman & Renshaw estimates that Avanir will pay IriSys royalties at a percentage of sales in the high single digits to low double digits.

Original article can be found here