Sun Pharma launches RIOMET ER diabetes drug in the US
Riomet ER™, dosed once daily, is the first and only FDA-approved liquid formulation of extended-release metformin.
Mumbai: Sun Pharmaceutical Industries Ltd. recently announced that one of its wholly-owned subsidiaries has launched Riomet ER™ in the U.S. as an adjunct to diet and exercise to improve glycemic control in patients 10 years of age and older with type 2 diabetes mellitus.
Riomet ER™ was approved by the U.S. Food and Drug Administration (FDA) on August 29, 2019.
Riomet ER™, dosed once daily, is the first and only FDA-approved liquid formulation of extended-release metformin. It can be prepped and poured, thereby eliminating the need to crush the medication. The availability of a liquid formulation addresses the needs of patients with type 2 diabetes mellitus, including residents in long-term care facilities, who often have issues swallowing solid medications. Riomet ER™ offers dosing flexibility and an acceptable taste.
"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," said Abhay Gandhi, CEO, North America, Sun Pharma. "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."
The label for Riomet ER™ carries a boxed warning about the risk of lactic acidosis with excessive alcohol intake, as alcohol increases the effect of Riomet ER™ on lactate metabolism. The label also includes a warning about the risk of vitamin B12 deficiency, as well as a warning about the risk of hypoglycemia with concomitant use with insulin and insulin secretagogues. In placebo-controlled clinical trials of Riomet ER™, the most common adverse reactions (occurring in greater than 5% of participants) were diarrhoea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.
More than 30 million Americans, or about 1 person in 10 in the U.S., have diabetes. The vast majority of those individuals (90% to 95%) have type 2 diabetes, which is also known as noninsulin-dependent diabetes. Although type 2 diabetes can affect people of any age, the disease occurs most often in middle-aged and older people. The risk of developing type 2 diabetes is increased in people who are age 45 or older, have a family history of diabetes, or are overweight or obese.