Athena's Diastat Backed In USA

The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously recommended approval of Athena Neurosciences' Diastat (diazepam rectal gel) for home use in the treatment of a severe form of epilepsy called acute repetitive seizures.

Diastat is a proprietary gel formulation of the product, which makes use of the fact that rectal absorption of active drugs is extremely rapid. Diastat achieves therapeutic blood levels of diazepam in about two minutes, according to Athena. Proposed labeling for the product will stress that this form should only be used in appropriate cases, and gives guidelines on when medical attention should be sought for this serious condition.

Currently, acute repetitive seizures, which occur mostly in children and young adults, are treated primarily in hospitals. However, some carers now use an injectable form of diazepam off-label for at-home use.