FDA Approves Synjardy XR for Adult Patients with Type 2 Diabetes

The FDA has approved Synjardy XR (empagliflozin and metformin hydrochloride, extended-release) tablets for the treatment of type 2 diabetes in adults. In combination with diet and exercise, Synjardy XR can improve blood sugar in patients.

Synjardy XR contains both empagliflozin and metformin. Empagliflozin is a sodium-glucose co-transporter 2 inhibitor that removes excess glucose through the urine. Metformin reduces glucose production by the liver.

The most common adverse events associated with Synjardy XR include stuffy or runny nose, sore throat, urinary tract infections, female genital infections, diarrhea, headache, nausea, and vomiting. The drug may also cause dehydration, as well as ketoacidosis. Ketoacidosis may require hospitalization, and it can present itself as nausea, vomiting, tiredness, and trouble breathing. In some instances, the condition can result in death. Lactic acidosis has also been reported.

"Adults with type 2 diabetes often take multiple medications, sometimes more than once a day, to manage their condition," Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals, said in a press release. Synjardy XR is marketed by Boehringer Ingelheim and Eli Lilly and Company. "With Synjardy XR, the eighth FDA-approved treatment to emerge from our partnership with Lilly, adults with type 2 diabetes now have another convenient daily option to help them reach their glycemic goals, whether they are already being treated or are just at the beginning of their treatment."