Lodotra is a new, modified-release tablet that has been developed in partnership with Nitec Pharma to optimize the efficacy of orally administered low-dose prednisone in rheumatoid arthritis.
Lodotra provides all the benefits of standard immediate release (IR) prednisone but has the additional advantage of significantly reducing morning symptoms combined with a convenient dosing regimen.
The diurnal rhythm in rheumatoid arthritis is characterized by elevated night time levels of inflammatory cytokines such as IL6, which leads to extreme stiffness and pain in the hours immediately after waking. Lodotra is an oral medication that has a unique delivery system ensuring rapid release of the prednisone from the tablet core about four hours after ingestion without disturbing sleep. This medication can be taken in the evening instead of in the morning like the current treatment.
The study compared the efficacy and safety of Lodotra given to patients before sleep the evening before with standard immediate-release (IR) prednisone. The duration of morning stiffness was significantly reduced in the Lodotra group while under standard IR prednisone no change in morning stiffness was shown.
In half the patients a reduction of more than one hour or one third was observed and those patients also showed a reduction in pain of one third. Lodotra was also shown to be well tolerated and just as safe as the standard regimen.