Questcor Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental new drug application (sNDA) seeking approval for H.P. Acthar gel (repository corticotropin injection) for the treatment of infantile spasms.

Questcor anticipates that the FDA will take action on the sNDA during the second quarter of 2007. No drug is currently approved in the United States for the treatment of infantile spasms.

H.P. Acthar gel is a natural adrenocorticotropic hormone (ACTH) designed to provide a prolonged release after intramuscular or subcutaneous injection. Acthar gel is currently indicated for the treatment of acute exacerbations of multiple sclerosis, and for several other diseases and disorders.

"Today's announcement demonstrates our continued commitment to the treatment of central nervous system diseases and disorders," said James Fares, Questcor's president and chief executive officer. "Acthar gel is an important drug today in the treatment of infantile spasms. However, we believe this filing supports an even greater role for Acthar gel in managing this life-threatening form of childhood epilepsy. We look forward to working closely with the FDA throughout this review process."

The sNDA provides clinical data to support the addition of the infantile spasms indication to the current Acthar gel label. Supportive information includes historical data on the use of Acthar gel in the treatment of infantile spasms, including the results from randomized clinical trials involving greater than 250 patients, which were published in peer-reviewed medical literature.

Infantile spasms (IS) is a seizure disorder of early childhood also known as West Syndrome. The onset is predominantly in the first year of life, typically between 3 to 6 months. The typical pattern of IS is a sudden bending forward and stiffening of the body, arms, and legs; although there can also be arching of the torso. Spasms tend to begin soon after arousal from sleep. Individual spasms typically last for 1 to 5 seconds and occur in clusters, ranging from 2 to 100 spasms at a time. Infants may have dozens of clusters and several hundred spasms per day. Infantile spasms usually stop by age 5, but are often replaced by other seizure types. IS is characterized by seizures, hypsarrhythmia (abnormal, chaotic brain wave patterns), and mental retardation. Other neurological disorders, such as cerebral palsy, may be seen in 30-50% of those with IS. The incidence of IS is estimated to be about 1 per 2,000 to 4,000 live births. It is the most frequent type of epileptic encephalopathy, the group of conditions in which epilepsy determines cognitive deterioration. No drug is currently approved in the United States for the treatment of IS. Patients diagnosed with this disorder are typically treated with a variety of agents, including Acthar gel.