AstraZeneca gets FDA nod for alternative administration of oral heart med

AstraZeneca's ($AZN) Brilinta can now be crushed and mixed with water or delivered through the nose via a tube, the FDA said, in a move designed to help patients who are unable to swallow the 90-mg tablets whole.

The blood-thinning oral antiplatelet therapy to prevent repeat heart attacks and strokes is the first P2Y12 inhibitor to receive approval for administration in that crushed manner.

AstraZeneca points out that the elderly and patients who experience a heart attack may have difficulty swallowing medications, especially in an emergency setting. A survey (PDF) about the difficulty patients experience in following common administration techniques found that a surprising 25% of doctors think patients need to be shown how to swallow medication at least once, while 7% said two to four repetitions are needed.

The new delivery option comes on the heels of the Pegasus-Timi study to expand the drug's indication, which found that when taken in combination with aspirin, Brilinta can help prevent events like cardiovascular death, stroke and heart attack for more than a year after an initial heart attack (though only by a small amount). Currently, it is only advised for use in the first year after a heart attack.

"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 AstraZeneca Vice President Steven Zelenkofske in a statement. "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."

P2Y12 is a receptor that plays an important role in encouraging the formation of blood clots, according to Medscape. Other drugs in that class include Bristol-Myers Squibb ($BMY) and Sanofi's ($SNY) Plavix as well as Eli Lilly ($LLY) and Daiichi Sankyo's Effient.

Others have taken a similar tack as AstraZeneca in a bid to differentiate their medicines. Impax Laboratories ($IPXL) says that for patients with difficulty swallowing, the capsule of its Parkinson's med, Rytary, can be opened so that the beads within can be sprinkled on applesauce.

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