Old Drugs Find New Paths to the Brain
Old Drugs Find New Paths to the Brain
Dr. Sperling, Baldwin Keyes Professor of Neurology, Thomas Jefferson University, Philadelphia, Pennsylvania, was kind enough to respond by email to questions about this unique method of diazepam administration.
Medscape: How did you get involved in this research?
Dr. Sperling: I became involved through working on the clinical trial conducted on inpatients in the epilepsy monitoring unit by members of the Epilepsy Consortium, a group of epilepsy centers that operate jointly to design, facilitate, and conduct epilepsy therapeutic trials and perform quality assurance. Jackie French, MD, is president of the consortium.
Medscape: Is this an "orphan drug" program?
Dr. Sperling: The US Food and Drug Administration (FDA) granted intranasal diazepam orphan drug status in 2012.
Medscape: Which patients would benefit from intranasal diazepam?
Dr. Sperling: Intranasal diazepam is designed for people who need acute rescue therapy. This would include people with repeated seizures (also called "seizure clusters") and people with prolonged seizures.
Right now, the only available nonoral rescue therapy is rectal diazepam, which requires an awkward and socially embarrassing treatment method. I suspect that most people would opt for an intranasal treatment in place of rectal medication, and that more patients would be candidates for acute therapy.
Medscape: In your experience, what are the important side effects with intranasal diazepam?
Dr. Sperling: Some patients experienced rhinorrhea or some stinging in the nasal passages, but these side effects are relatively mild. Because the drug was administered in the acute setting of seizures, other side effects, such as tiredness or lethargy, are difficult to separate from the expected postictal state.
Medscape: Did you have any problem with respiratory depression?
Dr. Sperling: Although that is in theory a concern, it has not been an issue with the rectal diazepam formulation. Because the absorption curve of intranasal diazepam is quite similar to the rectal absorption curve, I would not anticipate problems in this regard.
Medscape: A recent study published in the New England Journal of Medicine demonstrated that intramuscular midazolam was at least as safe as intravenous lorazepam. How would intranasal diazepam (or midazolam) compare with the intramuscular route?
Dr. Sperling: The rate of absorption is similar for both products. Because rescue therapy is designed to be used by patients or their caregivers, a nasal route of administration is far preferable to an injection.
Medscape: What is the time frame for future FDA approval of intranasal epilepsy therapy?
Dr. Sperling: I suspect that we will have intranasal therapy available within 1-2 years.
Medscape: Do you need any help recruiting for any ongoing trials?
Dr. Sperling: The intranasal diazepam trial that we conducted is not presently recruiting, but we are still recruiting patients for an outpatient intranasal midazolam trial. More information can be obtained by contacting me or my research coordinator, Aaron Fedor (aaron.fedor@jefferson.edu).
Discussion With the Lead Investigator
Dr. Sperling, Baldwin Keyes Professor of Neurology, Thomas Jefferson University, Philadelphia, Pennsylvania, was kind enough to respond by email to questions about this unique method of diazepam administration.
Medscape: How did you get involved in this research?
Dr. Sperling: I became involved through working on the clinical trial conducted on inpatients in the epilepsy monitoring unit by members of the Epilepsy Consortium, a group of epilepsy centers that operate jointly to design, facilitate, and conduct epilepsy therapeutic trials and perform quality assurance. Jackie French, MD, is president of the consortium.
Medscape: Is this an "orphan drug" program?
Dr. Sperling: The US Food and Drug Administration (FDA) granted intranasal diazepam orphan drug status in 2012.
Medscape: Which patients would benefit from intranasal diazepam?
Dr. Sperling: Intranasal diazepam is designed for people who need acute rescue therapy. This would include people with repeated seizures (also called "seizure clusters") and people with prolonged seizures.
Right now, the only available nonoral rescue therapy is rectal diazepam, which requires an awkward and socially embarrassing treatment method. I suspect that most people would opt for an intranasal treatment in place of rectal medication, and that more patients would be candidates for acute therapy.
Medscape: In your experience, what are the important side effects with intranasal diazepam?
Dr. Sperling: Some patients experienced rhinorrhea or some stinging in the nasal passages, but these side effects are relatively mild. Because the drug was administered in the acute setting of seizures, other side effects, such as tiredness or lethargy, are difficult to separate from the expected postictal state.
Medscape: Did you have any problem with respiratory depression?
Dr. Sperling: Although that is in theory a concern, it has not been an issue with the rectal diazepam formulation. Because the absorption curve of intranasal diazepam is quite similar to the rectal absorption curve, I would not anticipate problems in this regard.
Medscape: A recent study published in the New England Journal of Medicine demonstrated that intramuscular midazolam was at least as safe as intravenous lorazepam. How would intranasal diazepam (or midazolam) compare with the intramuscular route?
Dr. Sperling: The rate of absorption is similar for both products. Because rescue therapy is designed to be used by patients or their caregivers, a nasal route of administration is far preferable to an injection.
Medscape: What is the time frame for future FDA approval of intranasal epilepsy therapy?
Dr. Sperling: I suspect that we will have intranasal therapy available within 1-2 years.
Medscape: Do you need any help recruiting for any ongoing trials?
Dr. Sperling: The intranasal diazepam trial that we conducted is not presently recruiting, but we are still recruiting patients for an outpatient intranasal midazolam trial. More information can be obtained by contacting me or my research coordinator, Aaron Fedor (aaron.fedor@jefferson.edu).
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