Alfasigma USA Reintroduces IBS-C Drug Zelnorm to U.S. Market

Approximately 75% of the people in the United States who suffer from irritable bowel syndrome with constipation are women. While there are a number of treatment options available, many patients are dissatisfied with them due to lack of efficacy or side effects.

But now, an older and trusted drug for IBS-C has returned to the market in the U.S. In August, Alfasigma USA, the American branch of Italy-based Alfasigma based in New Jersey, secured the rights to Zelnorm, which was recently re-approved by the U.S. Food and Drug Administration for the treatment of IBS-C. Bryan Downey, chief executive officer of Alfasigma USA, told BioSpace in an exclusive interview that Zelnorm is the company’s “first toe in the water” as a U.S. pharmaceutical company.

Originally a Novartis medication, Zelnorm, a serotonin-4 (5-HT4) receptor agonist, was first approved in 2002 as the first prescription medication for IBS-C. But, in 2007, the drug was removed from the market due to cardiovascular concerns. After multiple safety studies were conducted, the FDA reapproved Zelnorm for the market in March for women under 65 years of age with IBS-C, which is characterized by frequent abdominal pain and altered bowel habits with predominant constipation. In June, Alfasigma USA acquired Zelnorm and relaunched the medication.

Downey, who came over to Alfasigma two years ago from Sanofi, said his team has been “carrying the information” about Zelnorm’s availability to doctors and are re-confirming with them the updated safety profiles. Dr. John Kincaid, head of medical affairs at Alfasigma USA, said the safety trials showed that less than .01% of patients who received the drug in clinical trials had a major cardiovascular problem. There was also no major Major Adverse Cardiovascular Events (MACE) in the data from patients without the preexisting cardiovascular events or risk factors, he added.

It was that new safety data, as well as the name recognition for Zelnorm that, in part, drew Alfasigma to the medication. Downey said when he heard Zelnorm was now available, he became excited.

“Everyone knew the drug. It was the first of its kind in this space,” he said. “We conducted our own marketing research and the recognition for it was still high. It has a unique mechanism of action in the IBSC patients and there’s not another product like it. It fit their ambitions nicely,” he said.

Downey added that with IBS-C patients, there’s still an unmet need as many patients are not happy with their treatment options and Zelnorm could provide the relief they need. He expressed confidence that the re-introduced Zelnorm will do well in the space despite new drugs that have been developed, such as Ardelyx’s Tenapanor, which could be approved by the FDA this week.

“There’s a lot of noise from other products, which is a great thing for patients,” Downey said. “The newer drugs have a different mechanism of action and focus and we will point to that.”

As Alfasigma USA moves forward with Zelnorm, Downey said the company is expanding its pipeline in order to grow its presence in the pharmaceutical space. In July, the company licensed Brilacidin from Innovation Pharmaceuticals for more than $24 million. Alfasigma will develop Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis. The company is also working with Theravance Biopharma to develop velusetrag for gastroparesis. Downey said he anticipates 2023 or 2024 for the first significant news out of those assets. The company is also working with Salix Pharmaceuticals to develop a reformulation of Xifaxin as a treatment for Crohn’s disease.

As Alfasigma USA firms up its position in the U.S. pharma landscape, Downey said the company will maintain a concentration on gastroenterology and is focused on how their long-term strategy will benefit that focus.

“We have a very long view of the future. Our vision is set out at least 10 years in the future,” Downey said. “We are moving at a right pace with a passion for pharmaceuticals and doing the right thing for patients.”

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