REDWOOD CITY, Calif., Aug. 30, 2016 (GLOBE NEWSWIRE) -- Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that the Phase 4 TOURMALINE study, which compared the efficacy and safety of Veltassa® (patiromer) for oral suspension given with or without food for the treatment of hyperkalemia, met its primary endpoint. Results showed no statistically significant difference in the percent of patients achieving either week 3 or week 4 serum potassium in the target range (3.8 - 5.0 mEq/L) between the group taking Veltassa with food and that taking it without. Adverse events with Veltassa in this study were consistent with previous clinical trials. Data from the TOURMALINE study will be submitted for presentation at a future medical meeting and shared with the U.S. Food and Drug Administration (FDA).
“In clinical studies supporting its approval, Veltassa was administered with food and its prescribing information requires Veltassa be taken with food,” said Lance Berman, M.D., chief medical officer of Relypsa. “We’re pleased that this study showed a similar efficacy and safety profile whether Veltassa was taken with or without food and will discuss these results with the FDA.”
Previous clinical studies of Veltassa evaluated its safety and efficacy when taken with food. The TOURMALINE study was designed to compare the safety and efficacy of Veltassa when taken with or without food.
The TOURMALINE study evaluated 114 patients in the United States with blood potassium levels ≥5.1 to <6.5 mEq/L. Patients in the study were randomly assigned to receive Veltassa once-a-day at a starting dose of 8.4 g/day, either with or without food. Patients were treated for four weeks and followed for two weeks after completing Veltassa treatment. The primary endpoint was a comparison of the proportion of patients with either week 3 or week 4 serum potassium in the target range (3.8 - 5.0 mEq/L).
Approximately 3 million people in the United States with stage 3 or 4 chronic kidney disease (CKD) and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include renin angiotensin aldosterone system (RAAS) inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors.
Veltassa is a potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water (one-third of a cup) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.
IMPORTANT SAFETY INFORMATION
The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. Other oral medications should be administered at least 6 hours before or 6 hours after Veltassa. Doctors should choose Veltassa or the other oral medication if adequate dosing separation is not possible.
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.
Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.
The most common adverse reactions (incidence ≥2 percent) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.
For additional Important Safety Information and Veltassa’s full Prescribing Information, please visit www.relypsa.com/veltassa/prescribing-information.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Relypsa, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans to submit the results from the Tourmaline study for presentation at a future medical meeting, our plans to discuss the results of the Tourmaline study with the FDA. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development and commercialization process, including regulatory requirements, the timing of Relypsa’s regulatory filings, Relypsa’s substantial dependence on Veltassa, Relypsa’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of Veltassa. Relypsa undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Relypsa in general, see Relypsa’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016.
Last updated on: 31/08/2016
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