FDA approves reintroduction of Sloan Pharma's Zelnorm
The Food and Drug Administration has cleared US WorldMeds' Sloan Pharma subsidiary's reintroduction of branded drug Zelnorm (tegaserod), a twice-daily oral treatment for irritable bowel syndrome with constipation, or IBS-C, in women under 65 years old.
Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women. Despite usage that made Zelnorm the prescription market leader in IBS-C, it was voluntarily withdrawn from the U.S. market in 2007 due to a potential safety signal. Zelnorm has remained consistently available in the U.S. through an expanded access program authorized by the FDA and is used by IBS-C patients in several other countries.
Zelnorm is the only selective serotonin-4 receptor agonist approved to treat IBS-C. It provides a unique treatment by targeting the 5-HT4 receptor at multiple neurons and smooth muscle cells in the gastrointestinal tract to induce contraction and relaxation, and decrease pain signaling.
"We are excited about what the reintroduction of Zelnorm means for patients suffering from IBS-C. We have continually heard from patients and clinicians alike that the IBS-C community is eager to have Zelnorm return to the United States as an available treatment option," US WorldMeds CEO P. Breckinridge Jones said.
Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women. Despite usage that made Zelnorm the prescription market leader in IBS-C, it was voluntarily withdrawn from the U.S. market in 2007 due to a potential safety signal. Zelnorm has remained consistently available in the U.S. through an expanded access program authorized by the FDA and is used by IBS-C patients in several other countries.
Zelnorm is the only selective serotonin-4 receptor agonist approved to treat IBS-C. It provides a unique treatment by targeting the 5-HT4 receptor at multiple neurons and smooth muscle cells in the gastrointestinal tract to induce contraction and relaxation, and decrease pain signaling.
"We are excited about what the reintroduction of Zelnorm means for patients suffering from IBS-C. We have continually heard from patients and clinicians alike that the IBS-C community is eager to have Zelnorm return to the United States as an available treatment option," US WorldMeds CEO P. Breckinridge Jones said.