An upside mover in early trading on Monday is AVANIR Pharmaceuticals (AVNR). Shares have seen a high of +36%, and volume has been 108.91% above its 20-day average
The Company reached a definitive agreement with the FDA, under the Special Protocol Assessment (SPA) process, on the design of a single confirmatory Phase III clinical trial of Zenvia(TM) (dextromethorphan/quinidine) for the treatment of patients with pseudobulbar affect in patients with amyotrophic lateral sclerosis and multiple sclerosis.The study will assess the safety, efficacy pharmacokinetics of two doses. The primary efficacy analysis will be based on the changes in crying/laughing episode rates recorded in the patient diary. The trial is expected to begin by the end of 2007.
Pseudobulbar affect, also known as involuntary emotional expression disorder (IEED) and emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. Pseudobulbar affect is estimated to impact more than 1 million people in the United States with underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, dementias including Alzheimer's disease, stroke, and traumatic brain injury. Episodes may occur when disease or injury damages the area of the brain that controls normal expression of emotion. This damage can disrupt brain signaling causing a "short circuit" and triggering involuntary episodes. There are currently no FDA approved treatments for pseudobulbar affect.
Zenvia is a combination of two well-characterized compounds, the active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This dual action glutamate inhibitor is believed to help regulate excitatory neurotransmission to diminish the unpredictable emotional episodes of pseudobulbar affect.
Earlier this year, AVANIR announced positive top-line results from its Phase III clinical trial evaluating Zenvia in diabetic peripheral neuropathic pain. Both Zenvia treatment groups had lower pain ratings than placebo patients. The most commonly reported adverse events were dizziness, nausea, diarrhea, fatigue and somnolence and were generally mild to moderate in nature.
"Current treatment options are either partially effective or don't work at all for more than one-half of people suffering from diabetic neuropathic pain. The results of this study provide additional evidence that Zenvia, if approved, may be a safe and effective treatment option for the millions of Americans suffering from diabetic neuropathic pain," said Keith A. Katkin, President and CEO of Avanir Pharmaceuticals.
AVANIR'S Abreva(R), docosanol 10% topical cream treatment for recurrent herpes simplex labialis episodes (episodes of cold sores or fever blisters) that is marketed by GlaxoSmithKline PLC (GSK), is the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms. According to Pharmacy Times Magazine, Abreva is the most recommended treatment by pharmacists for cold sores.
The Company recently completed the sale of currently marketed antipsychotic drug FazaClo(R) (clozapine) to Azur Pharma in Ireland for an upfront payment of $42 million, plus an additional $1.9 million in working capital adjustments. AVANIR could also receive up to an additional $10 million in payments in 2009 contingent upon certain regulatory conditions, and up to $2 million in royalties, based on 3% of annualized net product revenues in excess of $17 million.
For the third fiscal quarter ended June 30, 2007, the Company cut its losses to $0.23 per share, compared with a net loss of $0.56 per share, for the comparable quarter in 2006. The Company has cumulative net losses of approximately $248 million and cash and cash equivalents of $7.5 million.
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