The Food and Drug Administration (FDA) has approved a longer shelf life for Nityr (nitisinone; Cycle), extending it from 24 to 36 months at room temperature.
Nityr, a hydroxyphenyl-pyruvate dioxygenase inhibitor, is indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is currently the only nitisinone tablet that does not require refrigeration. The extended shelf life comes after the Company obtained required stability data for the formulation.
“One of our improvement targets was to produce a stable formulation with minimum formation of impurities, that could be kept outside of the fridge and not just for a few weeks,” said Brian Sergenian, North American Director of Cycle.
HT-1 is a rare genetic disease that can cause hepatic, renal and peripheral nerve damage. There are an estimated 200 people in the US who have the disease.
The product is supplied in 2mg, 5mg, and 10mg tablets. For patients who have difficulty swallowing, the tablets may be disintegrated in water and administered via oral syringe.
For information visit cyclepharma.com.