Development of Lodotra

Taken from NRAS magazine, Winter 2009

Lodotra is the brand name of a circadian cytokine modulator and is based on a night-time release formulation of prednisone. A rise in pro-inflammatory cytokine levels at night is responsible for the morning stiffness associated with RA; so by synchronizing prednisone delivery time with the person’s elevated cytokine rhythm, Lodotra™ takes effect at a physiologically optimal point to inhibit cytokine production and thus significantly reduce symptoms.

Lodotra takes the form of a specially formulated tablet using a delayed release technology which, once ingested, does not release the prednisone until approximately four hours later. This way, someone can swallow the tablet at 10pm before going to sleep and the dose of prednisone will not be released until 2am and will reach maximum levels at 4am; the optimal timing to relieve the stiffness and pain on waking.

This product completed a European trial in the treatment of RA and associated morning stiffness in 2006 and in April 2009 the first national European launch took place in Germany.