Ironwood, AbbVie add ‘bloating’ and ‘discomfort’ to Linzess label to reach more IBS-C patients


Ironwood and AbbVie can now add “bloating” and “discomfort” to marketing for irritable bowel syndrome with constipation (IBS-C) drug Linzess, thanks to a supplemental NDA approval from the FDA Thursday.

While a few words may not seem like a big deal, the addition of those patient-reported descriptions could help expand Linzess’ physician and patient base. The ability to market using specific words will broaden physicians’ view on who may be a potential Linzess candidate, while also helping patients see themselves within the more detailed array of symptoms, Ironwood Chief Commercial Officer Mark Plinio said.

“When a patient goes in to talk about their IBS symptoms, the conversation generally tends to focus on constipation as a kind of catch-all. But when they say constipation they also mean all these other symptoms—bloating, pain, discomfort et cetera,” Plinio said.

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Sometimes patients don’t make the connection between their discomfort and bloating to their constipation. The new terms may speed that realization. 

AbbVie and Ironwood’s sNDA scored FDA approval after the drugmakers submitted clinical data last November showing that Linzess reduced bloating, pain and discomfort in patients.

A new DTC campaign is in the works for spring and will reflect the newly approved symptom descriptions. However, two newer TV ads, begun in April and September, already alert potential patients to “belly pain and bloating” as symptoms. Previous TV ads for Linzess only mentioned “belly pain and recurring constipation.”

AbbVie and Ironwood’s marketing for Linzess has long focused on encouraging patients to switch from over-the-counter remedies to treat constipation. The new symptom descriptors could help that cause.

When the Linzess clinical data came out last May, analysts were quick to jump to the marketing conclusion, noting that the added words could convince more consumers to ask for the drug. At the time, they concluded AbbVie and Linzess could likely begin marketing the data right away without a label update.

RELATED: Ironwood, Allergan’s new Linzess pain data could cue much-needed prescription jump

Allergan and Ironwood have co-marketed Linzess since 2015. With the AbbVie buyout of Allergan, the partnership continues, and Plinio noted the possibility of additional benefits as a result of the acquisition.

For one, AbbVie’s media presence and buying power will likely afford better deals. The Illinois drugmaker’s patient services platform is another place Linzess could reap benefits, with better support potentially helping keep patients on the brand, Plinio said.

In the past year, the drugmakers spent more than $35 million on national TV ad buys to promote Linzess.



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