XR version of Synjardy gets FDA’s nod

The extended-release version of the product that combines empagliflozin and metformin hydrochloride has received Food and Drug Administration approval for use in the management of blood sugar in adults with type 2 diabetes. The drug, to be marketed as Synjardy XR by Boehringer Ingelheim and Eli Lilly, is intended for use with a diet and exercise program.

Its standard release formulation was approved in August 2015.

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FDA approved the extended-release version on Dec. 12. The updated label includes a boxed warning regarding the risk of metformin-associated lactic acidosis

Empagliflozin recently received an FDA indication as a medication for use in reducing the risk of cardiovascular death in patients with type 2 diabetes and concomitant cardiovascular disease, the first drug for type 2 diabetes to do so.

The label includes information of the drug’s four doses, all of which contain 1,000 mg of metformin plus empagliflozin in strengths of 5 mg, 10 mg, 12.5 mg, and 25 mg.

Among patients who are already taking metformin and plan to begin a regimen of Synjardy XR, their best choice is to switch to the formulation containing a similar daily dose of metformin and a total daily dose of 10 mg empagliflozin. Those already on empagliflozin should switch to Synjardy XR containing the same daily dose of empagliflozin and a total daily dose of 1,000 mg metformin. Dosing may be adjusted upward on the basis of effectiveness and tolerability up to a maximum of 25 mg empagliflozin/2,000 mg metformin, taken once daily with a meal in the morning.

Synjardy XR is contraindicated in patients with an estimated glomerular filtration rate of less than 45 mL/min per 1.73 m². Renal function should be assessed in patients with impaired renal function before taking Synjardy XR.

Several clinical trials tested coadministration of metformin and empagliflozin. In the largest, 637 patients with type 2 diabetes who were inadequately controlled (hemoglobin A_1c of 7%-10%) with 1,500 mg metformin were randomized to receive placebo, 10 mg empagliflozin, or 25 mg empagliflozin for 24 weeks. Both the 10-mg and 25-mg dosages of empagliflozin resulted in significant reductions compared with placebo in HbA_1c (–0.7% and –0.8%, respectively) fasting glucose (–26 mg/dL and –29 mg/dL), and body weight (–2 kg and –2.5 kg).

The single-pill formulation of Synjardy XR was not tested in clinical trials for efficacy; however, several trials performed in healthy subjects showed bioequivalence of the fixed dose combination, compared with separate pills.
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