News

Long-acting Synjardy gets FDA approval for type 2 diabetes treatment in the US

The US Food and Drug Administration (FDA) has approved the slow release form of Synjardy.
Synjardy is a drug used by people with type 2 diabetes in the UK as a twice daily single pill combination therapy to lower blood sugar levels.
The new Synjardy XR is a combination of the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) with a different and steadier formulation of metformin in a once-a-day treatment.
Empagliflozin removes excess sugar through the urine by blocking its re-absorption in the kidney while metformin lowers glucose production by the liver.
Metformin in combination with empagliflozin has been shown to decrease blood sugar levels and body weight, as well as lower blood pressure.
The substitution of metformin for metformin XR reduces some of the uncomfortable intestinal side effects, such as gas and bloating, which some people may have trouble tolerating when on a standard metformin.
The use of Synjardy XR is recommended, in the US, when the maximum dose of metformin alone, or metformin alongside other glucose-lowering products, does not suffice to adequately control blood sugar levels.
The clinical trials that led to the FDA approval yielded positive results when Synjardy XR is used alone or in combination with a sulphonylurea for the treatment of type 2 diabetes. It is however not intended for that of type 1 diabetes or diabetic ketoacidosis.
The most serious side effect from metformin in Synjardy XR is the build-up of lactic acid in the blood (Lactic acidosis), which is predominantly seen in people with kidney problems and can be life-threatening if left untreated.
Other adverse effects include dehydration, low blood pressure and complications from high levels of ketones in the blood.
Regular Synjardy, which is to be taken twice-daily, is already available in the UK in a range of different doses.
If the extended release version of the drug, Synjardy XR, is approved on the NHS, it could provide a more convenient daily option for people with type 2 diabetes to control their blood sugar levels.

To Top