Toxicity Studies of Nebulized Propofol Hemisuccinate

National Center For Advancing Translational Sciences

Investigators

Abstract

Epilepsy is a brain disorder that causes repeated seizures over time. The seizures can be disabling and, due to loss of muscle control, pose the risk of injuries from falling. An estimated 2 million Americans have epilepsy. A migraine is a common type of severe headache that causes nausea, vomiting and sensitivity to light. Migraines can run in families, and they affect women more often than men. Some migraines and epilepsy are not responsive to treatments. The drug propofol, used during surgery and medical procedures to sedate patients or put them to sleep, could be effective in treating or preventing migraines and seizures. The University of California, Davis is developing an inhaler device for patients whose conditions have not responded to routine therapy. Patients can use the inhaler to breathe in propofol just before or during a migraine or seizure. The lab has made progress towards the completion of the following studies: - Synthesis of Good Manufacturing Practice (GMP) material - Formulation development - Pharmacokinetic/absorption, distribution, metabolism, and excretion (PK/ADME) studies - Investigational New Drug (IND)-directed toxicology