Medical Food Definition
The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated
to be consumed or administered enterally under the supervision of a physician and which 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."
Our patent-protected Generally Recognized As Safe (GRAS) and cost-effective Prebiotic product is given to patients on
sulfonylurea anti-diabetes drugs as an adjunctive ingredient for the treatment. Clinical case studies on diabetes patients have
revealed that adjunctive intake of our Prebiotic together with sulfonylurea ameliorates clinically significant side effects of
sulfonylurea and extends its effectiveness.....Read More>>>
Problem with currently available anti-diabetes treatments
T2DM is an unmet medical need because the currently marketed anti-diabetes drugs generally have major side effects and limited
efficacy, necessitating multiple drugs to control most patient’s glycemia. Due to the intake of multiple drugs, each of which having
their own side effects, and the progressive nature of the disease, treatment for diabetes is often inadequate and poses major
challenges. T2DM patients often end up on insulin, which is expensive and can lead to serious side effects.
Sulfonylureas are still widely used and their long-term side effects are well characterized; with nearly half of patients with
T2DM in China, India, Brazil, Japan and Indonesia still being treated with sulfonylurea and about quarter of USA diabetes patients
receive sulfonylurea. This is because sulfonylurea is cheap and deemed sufficiently effective. Thus, in countries where majority of
T2DM patients reside, diagnosed patients are often initially prescribed with a sulfonylurea that have been in wide use for over 50
years. However, many patients taking sulfonylurea experience side effects such as increased risk of hypoglycemia and weight
gain and loss of efficacy within 6-12 months. We’ve hypothesized that sulfonylurea side effects and loss of efficacy is due to its
previously unrecognized antibiotic properties because sulfonylurea are derivatives of sulfonamide antibiotics (Sulfa drugs).
sulfonylurea side effects occur due to their chronic intake and inadvertent reduction in patient’s Essential Gut Good Bacteria.
Adjunctive intake of our patented prebiotic OZ101 in combination with all sulfonylurea class of anti-diabetes drugs may restore
patient’s Essential Gut Good Bacteria, which in turn may significantly ameliorate sulfonylurea’s major side effects and may
prolong its efficacy. This is because prebiotic OZ101 is composed of soluble dietary fiber and is a Good Food for the
Endogenous Gut Good Bacteria. The resultant combination treatment sustains near-normal blood glucose levels for several
years without the need for a dose change or intake of other anti-diabetes drugs.
About prebiotic OZ101
OZ101 tablet composed of plant-derived water extracted natural carbohydrate that has been given Generally Recognized As Safe
(GRAS) status by the USFDA, TGA, EMEA and other major regulatory authorities. OZ101 will be marketed as a "Medical Food"
and must be used under a physician supervision.
To receive free samples of OZ101 prebiotic, please do not hesitate to contact us at "firstname.lastname@example.org".
Type 2 Diabetes Mellitus
Diabetes is the fourth leading cause of global mortality by disease. Every year ~5 million diabetic patients die from diabetes
associated complications. T2DM is caused by a combination of insulin resistance and insufficient insulin production. Insulin is a
hormone secreted from pancreatic beta cells and is responsible for removing glucose from the blood to maintain normal blood
glucose levels. When food is digested, glucose is released into the blood stream causing an increase in blood glucose levels.
The increase in glucose triggers insulin secretion to assist with glucose transfer out of the blood. In T2DM, the presence of
insulin resistance requires an increase in insulin to be produced. However, when the pancreatic beta cells fail to produce
sufficient insulin, T2DM patients are unable to lower blood glucose levels back to the recommended level (5.5-7mmol/L).
According to International Diabetes Federation long term implications of elevated blood glucose include the risk of cardiovascular
disease, kidney damage, loss in vision, lower limb amputation. Risk factors include family history, unhealthy eating, lack of
exercise and overweight. Diabetes is an old disese and the earliest mention of diabetes was around 1552 BCE.
The number of patients diagnosed with type 2 diabetes increasing in an alarming rate and type 2 diabetes announced as a
pandemic disease by the United Nations. In 2017, the world had at least 425 million diagnosed type 2 diabetes patient,
accounting for over 5.7% of the world population, and is drastically rising.
Currently marketed anti-diabetes drugs
T2DM can be prevented through life style changes but there is no cure. Current treatments for diabetes include anti-diabetes
drugs, the most commonly prescribed forms are metformin and sulfonylureas. Anti-diabetes drugs assist control of blood
glucose levels through a number of different ways. However, their intake may have associated side effects, including:
- Weight gain
- Hypoglycaemia (critically low blood glucose levels)
- Significant congestive heart failure
- Bone fractures
- Increased cardiovascular risks
- Lactic acidosis
- Hypersensitivity reactions
- Low blood pressure
- Kidney failure
Currently marketed newer oral anti-diabetes drug classes provide moderate glycemic control but may have serious side
effects and high costs, which restrict their use. The long-term use of currently available drugs may cause cancer or failure of
the heart and the kidney. Thus, there is an immediate need for better, safer and ideally cheaper treatments for T2DM.
Advantage of OZ101
Based on a number of clinical case studies, competitive advantage of OZ101 is highlighted in table 3.
Our innovation is based on the discovery that when patients with T2DM
use sulfonylurea therapy in combination with the new OZ101 therapy the
major side effects of sulfonylurea, such as hypoglycaemia and weight
gain, are significantly reduced or eliminated and management of this
chronic disease is greatly improved such that sulfonylurea efficacy is
extended in terms of both strength and duration (from 6-12 months to over
5 years). This increased duration of efficacy is unusual for sulfonylurea
class of anti-diabetes drugs as demonstrated thorough conduct of 10
different clinical trials worldwide that illustrated in Figure 5 of a
peer-reviewed article published by (DeFronzo et al. Diabetes Care, 36,
Supp 2, S127-S138 (2013). Figure 1 depicts an illustration of the synergy
between sulfonylurea and OZ101.