FDA approves new administration option for Brilinta

March 31, 2015

FDA has approved a new administration option for ticagrelor (Brilinta, AstraZeneca) in acute coronary syndrome patients.

FDA has approved a new administration option for ticagrelor (Brilinta, AstraZeneca) in acute coronary syndrome patients. Brilinta has now become the first and only P2Y12 inhibitor with an FDA approval to be crushed and administered in water by swallowing or via nasogastric tube.

Survey data has shown that 40% of adults in the general population have trouble swallowing pills and furthermore, some patients who experience a heart attack have difficulty swallowing medications in an emergency situation.

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Brilinta is an oral antiplatelet treatment for acute coronary syndrome (ACS). ACS refers to a collection of conditions that result from insufficient blood flow to the heart. These include unstable angina (UA), non-ST-elevation myocardial infarction (NSTEMI), and ST-elevation myocardial infarction (STEMI). Brilinta is a direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation and has been shown to reduce the risk of thrombotic cardiovascular events, such as heart attack or cardiovascular death in ACS patients.

“We know that some patients who experience a heart attack are unable to swallow medications whole, yet it is important for these patients to receive and continue their oral antiplatelet therapy,” said Steven Zelenkofske, DO, vice president, US medical affairs, cardiovascular, AstraZeneca. “This label update, like the recent announcement of the PEGASUS TIMI-54 results, is an example of our ongoing commitment to addressing important unmet patient needs through advancing our understanding of Brilinta.”

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Brilinta is available in 90-mg tablets to be administered with a single 180-mg loading dose followed by a twice daily, 90-mg maintenance dose. Maintenance doses of aspirin greater than 100 mg may reduce the effectiveness of Brilinta and should be avoided in these patients. Dyspnea and an increased risk of bleeding are the most common adverse reactions associated with the use of Brilinta.