Aliso Viejo-based drug maker Avanir Pharmaceuticals Inc. is looking at new uses for its main drug.
Avanir recently filed an investigational new drug application with the Food and Drug Administration to start a large second-phase clinical trial for its drug to treat central neuropathic pain in multiple sclerosis patients.
Avanir said the application for its AVP-923 has been received by the FDA and is subject to a standard 30-day review.
The drug maker called treating central neuropathic pain in multiple sclerosis patients an “area of high unmet medical need” because there currently are no FDA-approved treatments for the condition.
More than half of patients with the neuromuscular disease “suffer from chronic and debilitating pain, with a substantial negative impact on their quality of life,” said Randall Kaye, the drug maker’s chief medical officer.
Avanir’s trial would involve 400 patients at 65 centers in the U.S. and other countries. It anticipates starting before the end of 2011.
Chief Executive Keith Katkin said the company intends to file another regulatory application within the next year to start looking at the potential use of AVP-923 to treat anger, irritability and other behavioral symptoms of dementia.
AVP-923 is approved under the name Nuedexta for treating pseudobulbar affect, a nervous system disorder that’s characterized by uncontrollable fits of crying or laughing.
Pseudobulbar affect often is seen in people with underlying neurological disorders such as multiple sclerosis, stroke, traumatic brain injuries or amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.
The FDA cleared Nuedexta, which was previously known as Zenvia, for pseudobulbar affect in November.
Prior to regulatory approval, Avanir, which moved to Aliso Viejo from San Diego in 2006, had seen several costly regulatory setbacks with Zenvia, including safety concerns about an ingredient in the compound.
Device Deals Expected
A pending multibillion-dollar acquisition by medical conglomerate Johnson & Johnson may be a sign of more medical device deals to come.
The New Brunswick, N.J.-based company recently said it planned to pay $20 billion for Synthes Inc., a West Chester, Pa.-based maker of devices to treat bone fractures and traumatic injuries, its largest deal ever.
A Reuters article cited the J&J-Synthes deal as an example of medical device makers looking at acquisitions as a way to get into growing markets amid the ongoing and relatively tepid economic recovery.
“As we move into an area where significant M&A is important, this ups the ante for the rest of the industry,” analyst Mike Mitchell of London investment bank Seymour Pierce told Reuters.
The J&J-Synthes deal did cause a mild breeze in Orange County—shares of Irvine heart valve maker Edwards Lifesciences Corp. fell slightly on April 18, when Synthes confirmed it was in talks with J&J.
Edwards has been seen as a potential J&J acquisition target, particularly in view of the progress of its Sapien less-invasive heart valve, which could be launched in the U.S. as early as October.
UCI Professor Makes Deal
University of California, Irvine, Professor Frank LaFerla is working with Palo Alto-based StemCells Inc. on the use of human neural stem cells in Alzheimer’s disease.
LaFerla directs UCI’s Institute for Memory Impairments and Neurological Disorders.
Alzheimer’s disease, which causes memory loss, is one of the more common forms of dementia.
StemCells, a publicly held company, has clinical trials under way in chronic spinal cord injury and Pelizaeus-Merzbacher disease, a rare childhood affliction. It also plans to file an application with the Food and Drug Administration this year for a clinical trial in age-related macular degeneration, a common cause of blindness.
LaFerla will keep his post at UCI.
Bits and Pieces
Irvine drug maker Spectrum Pharmaceuticals Inc. said the FDA approved a supplemental new drug application for an injectable, ready-to-use formulation of its Fusilev cancer drug … Watson Pharmaceuticals Inc., a drug maker founded by Anaheim Hills resident Allen Chao, has moved its corporate headquarters from Corona to Parsippany, N.J. … NVision Laser Eye Centers, a Newport Beach laser vision correction practice, said it added a 10th location in San Luis Obispo. NVision was created last year when eye surgeon Thomas Tooma bought the interest in eight Southern California eye centers from TLC Laser Eye Centers … Southern California College of Optometry in Fullerton said it received $690,444 from the UniHealth Foundation to help provide eye and vision care services at the JWCH Institute’s Center for Community Health on Skid Row in downtown Los Angeles … UCI Medical Center’s Breast Health Center received a full three-year accreditation from the American College of Surgeons.
