AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.
"The FDA approval of NUEDEXTA marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition," said Keith Katkin, president and chief executive officer of Avanir. "The approval of NUEDEXTA also marks AVANIR's transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA. We expect that NUEDEXTA will be available by prescription during the first quarter of 2011."
"PBA is a disabling neurologic condition commonly found in patients with underlying neurologic diseases or injuries. These patients frequently experience embarrassment due to their unpredictable emotional outbursts, leading to disruption of their interpersonal relationships and social isolation," said Erik P. Pioro, MD, PhD, FRCPC, Director of the Section for ALS and Related Disorders at the Cleveland Clinic in Cleveland, Ohio and an investigator in clinical studies evaluating NUEDEXTA. "As a physician who has cared for many patients with PBA, I am pleased that there is now a safe and effective treatment option for PBA that may help these patients regain more control over their daily lives and live with dignity."
NUEDEXTA is a first-in-class medication that acts on sigma-1 and NMDA receptors in the brain, although the exact mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (NYSE:MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.
AVANIR Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about AVANIR, please visit www.avanir.com.
Crown Equity Holdings, Inc. (OTCBB:CRWE) is expanding its business by opening another office in Pakistan. This office will be located in the city of Attock, Pakistan. This office will add an additional workforce of 25 associates to its CRWENewswire team, which will increase the company's up to date news and world affairs from the Mid-East, Far East and Europe online news wires.
"As always, I am thrilled to increase our team of correspondents to offer our readerships a global perspective on top stories." said Kenneth Bosket, President of Crown Equity Holdings Inc.
Crown Equity Holdings Inc. announced in June of this year its 1- 10 forward stock split, as well as in August announcing that the company had surpassed One Million dollars (1,000,000) in sales. The company is utilizing today's technology to advertise, promote and market public companies globally. CRWE's proprietary network technology allows their publishing department to get their content to millions of readers daily across the world. CRWE publishes financial content to all the major countries and covers all the accredited stock exchanges. The goal for 2010 is to have all CRWE's clients' press releases, articles and news content published in every major financial country's native language.
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