Tascenso ODT®, an orally disintegrating formulation of fingolimod, has been made available by Cycle Pharmaceuticals. The product is bioequivalent to, but not a generic of, Gilenya® (fingolimod) capsules.
Tascenso ODT is indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. The approval was supported by studies that established the bioequivalence between Tascenso ODT and Gilenya.
The new formulation may be taken with or without food or water. Patients who are currently being treated with Gilenya or another fingolimod product and have undergone first-dose monitoring at initiation may be switched to Tascenso ODT at the same daily dose without the need to repeat first-dose monitoring.
“For patients who are stable on fingolimod therapy, Tascenso ODT provides the opportunity for their ongoing therapy to remain consistent, whilst also accessing important patient support services not available with generic fingolimod and soon not available with Gilenya either,” said Clyde E. Markowitz, MD, Director Emeritus, Multiple Sclerosis Center, Associate Professor of Neurology, Perelman School of Medicine, University of Pennsylvania. “Reducing therapeutic uncertainty for these patients with the same fingolimod in a different formulation is a favorable option.”
Tascenso ODT is supplied as 0.25mg and 0.5mg orally disintegrating tablets in 30-count cartons containing 3 blister cards of 10 tablets per card. Support services will be offered to eligible patients through a program called Cycle Vita™.
- New drug, Tascenso ODT® (fingolimod), launched to meet the needs of multiple sclerosis patients in the US left without essential patient support. News release. Cycle Pharmaceuticals Ltd. Accessed February 13, 2023. https://www.businesswire.com/news/home/20230213005286/en/New-Drug-TASCENSO-ODT%C2%AE-fingolimod-Launched-to-Meet-the-Needs-of-Multiple-Sclerosis-Patients-in-the-US-Left-Without-Essential-Patient-Support.
- Tascenso ODT. Package insert. Cycle Pharmaceuticals Ltd; 2023. Accessed February 13, 2023. https://tascenso.com/Tascenso-ODT-PI-15-Dec-2022.pdf.