New FDA Medical Food Helps Early Memory Impairment
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Greeneville, S.C. - VAYA Pharma (a division of Enzymotec LTD) announced the availability of Vayacog® in pharmacies throughout North Carolina, South Carolina and Texas for the management of early memory impairment in the elderly.
Vayacog®, a once-daily formulation of phosphatidylserine - omega 3 compound, DHA enriched, is a prescription medical food which represents a new approach to helping manage early memory impairment in the elderly. Vayacog® has been clinically shown to safely improve short and long term memory abilities as well as learning skills. Vayacog® is a Medical Food regulated by the FDA under the Orphan Drug Act; must be used under a physician’s supervision; and is intended for the clinical dietary management of certain lipid imbalance associated with early memory impairment. Vayacog®’s recommended dose is one capsule daily or as directed by a physician.
"About 50% of the population or 20 million people in the United States aged 65 years or older suffer from cognitive impairment without dementia that disturbs their daily life as they usually forget the 'right' word, faces and places. Vayacog® is specially formulated to help elderly suffering from early memory impairment," says Yoel Asseraf, CEO of VAYA Pharma division.
Vayacog® Clinical Data
Vayacog® was evaluated during a 30-week, two-phase, clinical trial. The first 15-weeks double-blind, randomized, placebo-controlled phase involved 157 participants and demonstrated significant differences between Vayacog® and placebo groups in immediate and delayed memory recall and in total learning, specifically among participants with a relatively good cognitive performance prior treatment. The double-blind phase was followed by an open-label extension of additional 15-weeks during which all participants received Vayacog®. Safety data, obtained during both the double-blind study and the open-label extension, showed that Vayacog® was well tolerated with no significant side effects.
“The positive findings in this study, conducted by Prof. Korczyn, support this novel effective and safe management of early memory impairment,” says Dr. Yael Richter, R&D director of Vaya Pharma division. “The study results were recently published in the June 2010 edition of the peer-reviewed medical journal Dementia and Geriatric Cognitive Disorders.”
Early Memory Impairment
Memory is critical for all of our daily activities and allows us to retrieve events from the distant and recent past. Unfortunately, many people experience early memory impairment as they age as part of a progressive decline in overall cognitive function. This impairment is a characteristic of several intermediate stages between normal cognitive aging and dementia; such intermediate stages include subjective memory impairment (SMI) and mild cognitive impairment (MCI). SMI, the earliest sign of cognitive impairment, is a common condition in older persons with prevalence of 25% to 56%, among community-residing persons (≥65 years). It was recently reported that healthy older adults reporting SMI are about 4.5 times more likely to progress to more advanced stages of memory loss, such as MCI or dementia than those free of SCI. MCI is a condition in which subtle objective cognitive impairment is present without a dramatic impact on overall function and activities of daily living. It is believed that people with MCI have an approximately 10-fold increased risk of developing Alzheimer’s disease (AD) than people with normal memory.
“VAYA Pharma is proud to provide physicians and patients with a novel approach to optimize the management of early memory impairment, allowing physicians to treat patients earlier,” said Rick Morris, President and CEO of VAYA Pharma US operations.
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VAYA Pharma division is a research-based, specialty pharmaceutical division of Enzymotec LTD, dedicated to the discovery, development, manufacture and marketing of innovative, clinically tested effective and safe lipid-based products. VAYA Pharma Inc. USA is headquartered in Greenville, South Carolina.
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