Aliso Viejo-based drug maker Avanir Pharmaceuticals Inc.’s recent year-end conference call brought word that the company is enrolling subjects for four concurrent clinical trials for its AVP-923 and AVP-786 drug candidates.
AVP-923 is being looked at for treating agitation in Alzheimer’s disease patients in one of the studies, said Joao Siffert, the company’s senior vice president of research and development.
Siffert said that one of the trials was “off to a good start” with 23 sites across the U.S. currently recruiting patients.
“With no approved therapies for agitation associated with Alzheimer’s, managing the symptoms remains quite challenging for clinicians. Dementia-related behavioral symptoms, including agitation, can be extremely distressing to the individual, their families and the caregivers,” he said.
Avanir’s “prime study” is a second-phase clinical trial of AVP-923 for central neuropathic pain in multiple sclerosis. It expects to have data in the first half of 2014 for that clinical trial, Siffert said.
Another AVP-923 program involves looking at the drug candidate’s safety and efficacy in treating dyskinesia, or involuntary movements, brought on by the use of levodopa as treatment for Parkinson’s disease.
Avanir received a grant in October from the Michael J. Fox Foundation to fund that study. Siffert said it would enroll about 20 patients and would have top-line clinical data available in the first half of 2014.
Avanir’s fourth study will “explore the utility” of its AVP-786 drug candidate in several neurological and psychiatric disorders, Siffert said. AVP-786 is deuterium-modified dextromethorphan.
Dextromethorphan is a key ingredient in its Nuedexta drug.
“It’s been a very exciting time for Avanir in terms of new clinical data in the horizon,” Siffert said.
Avanir Chief Executive Keith Katkin later said that the combination of having Nuedexta approved for the pseudobulbar affect disorder with “a significant number of development opportunities for AVP-923” would help the drug maker become “the next mid-cap specialty biopharmaceutical company.”
New Commercial CEO for UnitedHealth
UnitedHealthcare has named Brandon Cuevas as chief executive of its commercial business for California. Cuevas is based at the insurer’s Cypress operations.
Minneapolis-based UnitedHealthcare serves more than 2.3 million plan participants in California, and employs about 8,600 people statewide, including 3,900 in Cypress.
Cuevas most recently served as the West region chief financial officer of UnitedHealthcare’s employer and individual business, which serves California and 12 other states. He’s had nearly two decades of healthcare experience, including serving as vice president of finance at PacifiCare Health Systems Inc., a Cypress-based health plan that UnitedHealth bought in 2005.
He is a graduate of Barclay College in Haviland, Kan., and Friends University in Wichita, Kan., and holds a bachelor of arts in business administration and theology, and a bachelor of business administration in accounting.
Masimo Aims for Apple Customers
Irvine-based Masimo Corp. has introduced iSpO2, a pulse oximeter designed for use with Apple Inc.’s iPhone, iPad or iPod touch. Pulse oximeters attach to a patient’s finger or toe and measure levels of oxygen in the blood.
Masimo said that iSpO2 is designed for consumer rather than medical use. The company said that customers can check their own blood oxygenation, pulse rate and perfusion index for sports and aviation uses.
The company’s iSpO2 Medical, which is a professional version of the device for medical use, is pending European Union and Food and Drug Administration 510 (k) clearance.
Billing Group in Demo Project
The Healthcare Billing and Management Association, a Laguna Beach-based trade group that represents third-party medical billing companies, said it will participate in a testing program offered by a Medicare contractor.
The association will be working with National Government Services Inc., a subsidiary of Indianapolis-based health insurer WellPoint Inc., on the project. Goals include developing process and methodology to pilot compliance testing of transaction standards, operating rules, code sets and other requirements based on medical billing industry feedback and participation, along with developing industry-wide best practices.
Other participants include Walgreen Co., the Chicago-based drug retailer, and the Englewood, Colo.-based Medical Group Management Association.
More than 30,000 workers at over 700 third-party medical billing firms are represented by the Healthcare Billing and Management Association. The association was established in 1993.
Bits and Pieces
Irvine-based medical device maker Brolex LLC said that its C Safe device for use in caesarian sections received top scores from Reviews in Obstetrics & Gynecology, a medical journal. C Safe is designed to perform safer caesarian sections by preventing lacerations to newborns. … Disc Sports and Spine Center said that its ambulatory surgery center in Newport Beach achieved reaccreditation by the Skokie, Ill.-based Accreditation Association for Ambulatory Health Care. The reaccreditation is for a three-year period. Apnea Sciences Corp., a Laguna Hills-based medical device maker, signed distribution deals with Termo-Kont MK Ltd. in Russia, International Healthcare Inc. in Europe, AS Asia Company Ltd. in Asia and Gaspar Holdings Co. in United Arab Emirates. Apnea makes SnoreRx, a device designed to cut down on snoring.