Lundbeck pointed out at a press conference that LGS is a rare and severe form of epilepsy. Patients are usually diagnosed during childhood and often continue into adulthood. EEG showed characteristic changes, accompanied by varying degrees of intelligent decline. The disease is accompanied by multiple types of seizures, and episodes of seizures occur frequently in certain periods, many of which occur daily.
The FDA approved Onfi is based on the results of two multicenter controlled studies. These two studies are very similar in terms of subject characteristics and previous treatment. One of the key Phase 3 studies included 238 patients who were currently or have been diagnosed with LGS. The primary endpoint was a fall-over episode (lost tension, ankylosing, or myoclonic) compared with a 4-week baseline period and a 12-week maintenance period. ) Percentage of weekly frequency of decline. Another study, Phase 2 dose change study, enrolled 68 patients. The results of the two trials are similar.
The most common adverse reactions in the phase 3 trial included lethargy or fatigue, fever, runny nose, aggressiveness, irritability, ataxia, and constipation.
It is expected that Onfi will enter the US pharmacy in early January 2012 and will have a choice of five, 10 and 20 mg tablets in three sizes.
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