Label Change Sought for Veltassa in Hyperkalemia Treatment

Relypsa is hoping to change its label for patiromer (Veltassa) for oral suspension based on the results of 12 phase 1 drug-drug interaction studies.

The manufacturer submitted a supplemental new drug application to the FDA for its hyperkalemia treatment, which was approved in October 2015.

Relypsa’s original new drug application included in vitro drug-drug interaction tests involving 28 drugs. Half of the drugs showed binding with Veltassa, and the other half did not.

Twelve of the 14 drugs that did show binding were then tested in healthy patients to determine whether the results in vitro actually had an effect in patients.

The phase 1 studies demonstrated that there was no clinically meaningful reduction in absorption for 9 of the 12 drugs when Veltassa and the other drugs were taken at the same time.

Three of the drugs did show reduced absorption, but when the dosing of Veltassa and the other 3 drugs were separated by 3 hours, the absorption problem was no longer an issue.

"We were encouraged by the results of our phase 1 drug-drug interaction studies, which showed no impact to absorption with any of the drugs tested when dosing with Veltassa was separated by 3 hours,” Lance Berman, MD, chief medical officer of Relypsa, said in a press release. “In addition, there was no clinically meaningful reduction in absorption for the majority of drugs tested when they were co-administered with Veltassa. We look forward to working with the FDA with the goal of updating Veltassa's label to reflect these data."

Veltassa’s current label has a boxed warning that the treatment may bind to other oral drugs, which could decrease their absorption and reduce their effectiveness.

The most common adverse effects associated with Veltassa include constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.

Approximately 3 million people in the United States who have stage 3 or 4 chronic kidney disease and/or heart failure also have hyperkalemia or elevated blood potassium levels.