IBS med Zelnorm relaunches more than a decade after disastrous recall—does it have a shot?

hope for the best
Alfasigma is hoping Zelnorm's return to the U.S. irritable bowel syndrome market will be a profitable one after a disastrous recall in 2007. (Pixabay)

Zelnorm was a steady seller for Novartis before cardiovascular red flags led to the irritable bowel syndrome (IBS) med’s collapse. Now—more than a decade after its recall and with new owners—Zelnorm's trying for a comeback.

The task won't be an easy one, though. When drugmaker Alfasigma relaunched Zelnorm in late July, it bore a label that's spookier than its competitors, and those rivals include some of the most-advertised drugs in the business.

Alfasigma, best known for its partnership with Salix to produce IBS-D med Xifaxan, acquired Zelnorm in early July from Sloan Pharma for an undisclosed sum. After what Alfasigma calls a "thorough safety review," the FDA had cleared the med to treat IBS with constipation (IBS-C) in women under 65. It had been available for limited use by special application to the FDA.

But even now, the drug comes with a daunting warning label that includes a risk of major cardiovascular events as well as ischemic colitis and suicidal thoughts, among others. The label does not bode well—particularly because its IBS competitors, including Allergan’s Linzess, don’t share those risks.

But has that stopped Alfasigma from seeing a niche for the drug? Not yet.

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Alfasigma CEO Bryan Downey said despite Zelnorm’s small indication, the drug could fill the need for a novel treatment among the 60% of IBS patients he said were dissatisfied on their current treatment.

“We've been met with excitement not only by us but with patients and providers in the space,” he said in an interview early this month. “Our focus will to be very clear what patient population we're talking about, and in that specific population we believe there’s a very specific unmet need.”

Zelnorm peaked at $560 million in sales before its 2009 recall, but the population it now targets is much smaller. And how exactly will Alfasigma sell a drug to physicians with so many red flags? The drugmaker said it would take a two-pronged approach: Stay on target, and tout the drug’s novel serotonin-4 receptor agonist mechanism.

“We are very careful about making sure that we are educating physicians about the appropriate use of the drug,” said John Kincaid, Alfasigma’s head of medical affairs. “Once we explain this is a safe drug to use in a certain population, we go back to what the drug is.”

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

Even if it has some success in courting physicians, though, Zelnorm will have to scrap to get ahead in an IBS market dominated by over-the-counter meds—a struggle Linzess knows all too well.

An early ad campaign for the brand focused on that very problem, depicting patients overwhelmed by a mountain of OTC drug packages. Allergan rolled out a new branded campaign last year, and an IBS-C awareness push kicked off in April.

Then, in June, a new batch of clinical data for Linzess freed the drug to use the terms “pain,” discomfort” and “bloating” in its IBS-C advertising, a win that gave Allergan hope the med could start to see a boost in scripts. The drug hit $191.8 million in second quarter sales, a 14% jump from the same period in 2018. 

RELATED: Oh My Gut! Allergan and Ironwood's IBS-C push links patients to telemedicine

Plus, Linzess and Zelnorm aren’t the only two contenders in the IBS-C field. Ardelyx’s long-gestating challenger tenapanor received an FDA approval of its own Thursday under the brand name Ibsrela.

Back in 2018, Ibsrela posted phase 3 trial data showing the drug increased the percentage of patients who had at least a 30% reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements in the same week for at least six of the 12 weeks of the treatment period by 13% over placebo.

Downey said Zelnorm has already listed at a price “significantly below” other competitors and would continue to stay competitive on price to entice payers.

“We're well aware of where this product will be positioned, and our plan is to fit that unmet need,” he said.

Editor's Note: This story has been updated to correct an error. Xifaxan is an IBS-D treatment.