Corticotrophin (Acthar) to cure infantile spasms under FDA review in US: Questcor

Repository corticotrophin injection (Acthar) to treat infantile spasms could be considered for approval by US FDA.

Questcor Pharmaceuticals, Inc has filed a supplemental New Drug Application (sNDA) to market H.P. Acthar Gel (repository corticotrophin injection) for the treatment of infantile spasms to US FDA.

Following request from US FDA Questcor has also provided a complete response to all prior action letters for its this H.P. Acthar Gel (repository corticotrophin injection) sNDA.

“The medical community and Questcor continue to believe that Acthar has an important role in the treatment of infantile spasms and we look forward to working with the FDA to answer any questions as they consider our application,” said Don M. Bailey, president and CEO of Questcor.

Acthar (repository corticotropin injection) is natural source ACTH (adrenocorticotropic hormone) in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection.

Acthar is currently approved in the U.S. for the treatment of MS exacerbations, nephrotic syndrome and many other conditions.

H.P. Acthar Gel is an injectable drug that is approved for the treatment of certain disorders with an inflammatory component, including the treatment of exacerbations associated with multiple sclerosis and to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythamatosus.

In the treatment of acute exacerbations of multiple sclerosis daily intramuscular doses of 80-120 units for 2-3 weeks may be administered.

Acthar is not approved in the U.S. for the treatment of infantile spasms.However, US FDA granted Orphan Designation to Acthar for the treatment of infantile spasm previously.

Infantile spasm is a potentially life-threatening disorder that typically begins in the first year of life. Infantile spasms (IS), a rare form of refractory childhood epilepsy, and opsoclonus myoclonus syndrome, a rare autoimmune-related childhood neurological disorder.

However, pursuant to guidelines published by the American Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted with this condition.

Questcor Pharmaceuticals, Inc. is a biopharmaceutical company focused on providing prescription drugs for the treatment of rare central nervous system and inflammatory diseases and disorders.Questcor Pharmaceuticals markets H.P. ActharGel (repository corticotropin injection).

Questcor Pharmaceuticals also markets Doral (quazepam), which is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.