Lodotra provides all the benefits of standard immediate release (IR) prednisone but has the additional advantage of reduced morning stiffness combined with a convenient dosing regimen.
Patients with rheumatoid arthritis often experience extreme stiffness and pain in the hours immediately after awaking. It has been established that these morning symptoms can be addressed with prednisone administered at 2am. However, until now this has been impossible without disturbing sleep. Lodotra is an oral medication that has a unique delivery system that ensures rapid release about 4 hours after ingestion.
In the study the duration of morning stiffness was significantly reduced when patients took Lodotra and in half the patients a reduction of more than one hour or one third was observed. Lodotra was also shown to be well tolerated and just as safe as the standard regimen. Importantly, IL6 levels were shown to be reduced.
Nitec Pharma said that it intended to apply the product to other indications such as Polymyalgia Rheumatica (PMR) and asthma
Nitec has already submitted Lodotra for marketing authorization in Europe in August and plan to seek marketing authorization for North America and the Far East.