The FDA grants orphan drug designation to products that are intended to treat rare or ‘orphaned’ diseases or conditions such as Lennox-Gastaut syndrome (LGS).
Tim Cunniff, vice president, global regulatory affairs, pharmacovigilance and clinical quality assurance from Ovation, said: “LGS is a devastating and difficult to treat form of childhood epilepsy that often leads to some form of mental retardation and other behavioral problems over time. Clobazam is being developed to provide physicians with an additional treatment option for patients with LGS, for whom there are very few safe and effective treatments.”