Accera Pharma - Axona - medical food
Axona provides an alternative energy source to brain cells
Glucose is the primary source of energy for the brain. Alzheimer's disease (AD) patients exhibit a decline in the ability to metabolize glucose in the brain. Inadequate glucose leads to damage resulting in impaired memory and cognition and brain shrinkage. These metabolic defects in the brain often appear 10 to 20 years earlier than other Alzheimer's symptoms.
Axona is converted by the liver into ketone bodies, which provide an efficient alternative fuel for brain cells. Ketone bodies are naturally occurring compounds that are produced mainly by the liver from fatty acids during periods of extended fasting. Ketone bodies have been demonstrated to protect neurons.
•Axona is a specially formulated medical food* intended for the clinical dietary management of the metabolic processes associated with mild-to-moderate AD
•Axona is a proprietary formulation of caprylic triglyceride
◦Caprylic triglyceride safely increases plasma concentrations of ketone bodies (predominantly BHB), which can provide an alternative energy source for the brains of AD patients
◦Caprylic triglycerides are metabolized differently than long-chain triglycerides and are not generally associated with increased blood cholesterol levels
•Clinical trials have shown that Axona improves cognitive function in some AD patients
•Axona is administered orally once a day, supplied as a powder to be mixed with water or other foods/liquids
•Administer after a meal, preferably breakfast or lunch
•Axona can be taken with commonly prescribed AD medications
•Axona's adverse events are primarily limited to the gastrointestinal tract
•Axona is administered under physician supervision and dispensed by prescription
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* A Medical Food is an FDA-regulated product, in a relatively new category of medical protocols defined by Congress as part of the Orphan Drug Act. A Medical Food is formulated to be consumed or administered enterally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Medical Foods can be prescription products, but are different than drugs or dietary supplements (also called nutraceuticals) in several aspects, such as their claims. Claims for both Medical Foods and drugs must be supported by solid laboratory and clinical data. Medical Food ingredients have Generally Recognized As Safe (GRAS) designation, the highest FDA standard of safety given to foods. Medical Foods, sometimes prescribed in addition to drugs, nonetheless represent an entirely different scientific and medical approach to managing diseases.