Lundbeck says it expects to file clobazam, a compound for the treatment of one of the most severe forms of epilepsy, in the USA after presenting postive late-stage data.
The Danish drugmaker, which got hold of the rights to clobazam last year with the acquisition of the USA’s Ovation Pharmaceuticals has announced “highly statistically significant positive findings” from a Phase III study. Data from the 238-patient trial demonstrated that the two highest doses of clobazam tested (0.5 and 1.0 mg/kg) versus placebo, showed a significant reduction in the number of drop seizures in patients suffering from Lennox-Gastaut syndrome from the four-week baseline time to the 12-week maintenance period.
Clobazam was generally well tolerated and “the overall safety profile in this study was consistent with that described in literature”, Lundbeck says. The company is now “initiating interactions with the FDA as well as scientific advisors” to discuss the study outcome and the plans for submitting a New Drug Application.
LGS is characterised by multiple seizure types and represents up to 10% of all childhood epilepsies. Sudden drop attacks are a central feature of LGS and frequently result in injury, Lundbeck noted, and up to 90% of children with the syndrome are affected by “developmental delay or regression and commonly experience behavioural and sleep disturbances as well”.
Currently, clobazam is available in more than 100 countries for various uses including the treatment of epilepsy and anxiety, although it is not currently approved for any use in the USA. As for LGS, the Copenhagen-headquartered company said no one antiepileptic drug provides satisfactory relief for all or most patients; ombination treatments are often required and many LGS sufferers are refractory to standard anti-epilepsy medicines.
“There is a clear need for new treatment options [and] we are delighted to see these encouraging data,” said Anders Gersel Pedersen, head of drug development at Lundbeck, He added that “clobazam has the potential to contribute, in a significant manner” to the firm’s growth in the years to come.”
