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Posted 2 May 2016 by Drugs.com
WOODCLIFF LAKE, N.J., May 2, 2016 /PRNewswire/ – Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Fycompa (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the Fycompa tablet formulation, and is expected to be available to patients in June 2016. "We are excited about the approval of Fycompa Oral Suspension, as it gives another option to patients with epilepsy who may have difficulty swallowing tablets or prefer liquids," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "The development of this new ... Read more
Posted 30 Jun 2015 by Drugs.com
Tokyo, June 22, 2015 – Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. The FDA's decision to approve the indication expansion was based on a placebo-controlled clinical phase III study (Study 332) of Fycompa in 164 patients aged 12 years and older with PGTC seizures. In the study, a statistically significant reduction in PGTC seizure frequency was observed in the Fycompa group compared with placebo (Fycompa: -76.5%, placebo: -38.4%, p Read more
Posted 25 Sep 2013 by Drugs.com
WEDNESDAY, Sept. 25 – Young children exposed to epilepsy drugs in the womb are at increased risk of having impaired fine motor skills, according to a new study. Exposure to the drugs in breast milk, however, does not appear to pose a threat. Researchers looked at data collected from Norwegian mothers about their children's language, behavior, and motor and social skills at the ages of 6 months, 18 months and 36 months. The women also provided information on breast-feeding during the first year for the study, which was published online Sept. 23 in the journal JAMA Neurology. Of the children in the study, 223 were exposed to one or more epilepsy drugs in the womb. At age 6 months, 11.5 percent of infants whose mothers took epilepsy drugs during pregnancy had impaired fine motor skills (which involve small muscle movements) compared with less than 5 percent of those who were not exposed ... Read more
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