The only FDA-approved liquid formulation of extended-release metformin is now available in the United States, according to a press release from Sun Pharma.
Liquid metformin (Riomet ER) was approved by the FDA in August as an adjunct to diet and exercise to improve glycemic response for patients with type 2 diabetes aged at least 10 years.
“As the fourth Sun Pharma product designed to address the needs of the 40% of U.S. adults who cannot or will not swallow solid medications, Riomet ER reflects our continued commitment to providing alternative formulations to underserved patient populations,” Abhay Gandhi, CEO of Sun Pharma in North America, said in the release. “Our sprinkle and liquid formulation products treat common, chronic diseases — type 2 diabetes, hypertension, elevated cholesterol, pain and depression — where adherence issues are common and can be life-threatening.”
Liquid metformin, dosed once daily, can be prepped and poured, eliminating the need to crush medication, according to the release. The availability of a liquid formulation with dosing flexibility addresses the needs of patients with type 2 diabetes who often have issues swallowing solid medications.
The only FDA-approved liquid formulation of extended-release metformin is now available in the United States.
The label for liquid metformin carries a boxed warning about the risk for lactic acidosis with excessive alcohol intake, as alcohol increases the effect of liquid metformin on lactate metabolism. The label also includes a warning about the risk for vitamin B12 deficiency, as well as a warning about risk for hypoglycemia with concomitant use with insulin and insulin secretagogues.
In placebo-controlled clinical trials of liquid metformin, the most common adverse reactions were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort and headache.
Disclosure: Gandhi is CEO of Sun Pharma in North America.