The State of Antiepileptic Drug Development
The State of Antiepileptic Drug Development
Editor's Note:
At this year's Eilat Conference on New Antiepileptic Drugs, held in Eilat, Israel, May 6-10, Andrew N. Wilner, MD, interviewed Roger Porter, MD, Chief Scientific Officer of The Epilepsy Therapy Project and Adjunct Professor of Neurology at the University of Pennsylvania, on the state of antiepileptic drug development.
Dr. Wilner: Dr. Porter, you have attended many of the Eilat Conferences over the past 20 years and thus have a long perspective on the development of epilepsy drugs. What has impressed you the most about this meeting compared with others over the years?
Dr. Porter: This meeting, in Eilat, Israel, is 1 of 2 meetings that I feel I must attend to keep up with what is happening with new antiseizure drugs. As you know, at the present time we are not looking at drugs that affect the fundamental properties of epileptogenesis. We are instead looking at drugs that work on seizures. Nonetheless, this is very important because symptomatic treatment is what prevents seizures in the majority of people.
The other important meeting for me is the Antiepileptic Drug Trials Conference, which is held in Florida in alternate years with the Eilat Conference. The most important features of these 2 meetings are to assess the progress of the various new drugs for epilepsy. Some of the meetings also include discussions about devices, but the Eilat meeting is exclusively devoted to drugs, and it is pharmacology-dominated and very sophisticated in many ways. It is a quick but very thorough update on what is happening with new drugs for seizure disorders.
Dr. Wilner: Several new drugs have been approved in the past 15 years. Yet, we often hear that epilepsy remains uncontrolled in 30% of people with the disease, and that number has not changed much despite the new drugs. Can you provide some perspective on these developments?
Dr. Porter: Yes. This is a bit of an enigma. We know that it is much more difficult, for example, to recruit patients for clinical trials now than it was in 1980, when I was conducting clinical trials on complex partial seizures. This is the most common type of seizure type in adults for which we conduct clinical trials. Today, it is much more difficult to find patients with poorly controlled complex partial seizures. One usually has to go to several other countries and even continents to find the number of sites necessary to recruit the participants that are required for these trials.
Dr. Wilner: That suggests that patients may have better outcomes now, but we do not have good statistics on this.
Dr. Porter: Correct. We do not have good statistics on this.
Trial design bears some responsibility too. For example, if we require patients to have 3 seizures a month to participate in a given clinical trial, and a new drug comes along that reduces seizure activity to 1 per month, the patients still consider their disease to be uncontrolled. Indeed, it is uncontrolled; the patients cannot drive, for example. But they are also now unable to participate in the clinical trial because they no longer meet the stringent criteria that we require.
Dr. Wilner: On the basis of your experience and what you have heard at this meeting, what is the best way to move forward to find drugs that will eliminate seizures in people with epilepsy?
Dr. Porter: We must pursue 2 fundamental processes and 2 parallel tracks. The number-1 basic science issue is the need to expand our knowledge about epileptogenesis. That is not what this meeting is about. This meeting is about symptomatic therapies, which is track number 2. It is equally important to keep up the momentum to find new drugs to stop seizures so that patients can live normal lives, whenever possible. Ninety percent of the new drugs discussed at this meeting came through the NINDS (National Institute of Neurological Disorders and Stroke) Screening Program. That screening program is absolutely critical for us to continue this second track of discovering symptomatic therapies.
Dr. Wilner: That is a government-funded program?
Dr. Porter: That is exactly right. This comes from the National Institutes of Health. It costs only about $3 million per year, but in the past 30 or 40 years, they have found about 9 drugs, and these drugs have revolutionized the way that patients are treated today for their epileptic conditions.
Dr. Wilner: You are Chief Scientific Officer of The Epilepsy Therapy Project. What is the Epilepsy Therapy Project?
Dr. Porter: The Epilepsy Therapy Project is a nonprofit organization devoted to finding new therapies, and our job is to find funding for potential new therapies that might not be funded by the usual mechanisms at the National Institutes of Health. We fund development of devices and early drug studies; we try to find therapies that are close to marketing. We have a limited budget, but we are growing and hoping to be more effective in the future.
Editor's Note:
At this year's Eilat Conference on New Antiepileptic Drugs, held in Eilat, Israel, May 6-10, Andrew N. Wilner, MD, interviewed Roger Porter, MD, Chief Scientific Officer of The Epilepsy Therapy Project and Adjunct Professor of Neurology at the University of Pennsylvania, on the state of antiepileptic drug development.
Dr. Wilner: Dr. Porter, you have attended many of the Eilat Conferences over the past 20 years and thus have a long perspective on the development of epilepsy drugs. What has impressed you the most about this meeting compared with others over the years?
Dr. Porter: This meeting, in Eilat, Israel, is 1 of 2 meetings that I feel I must attend to keep up with what is happening with new antiseizure drugs. As you know, at the present time we are not looking at drugs that affect the fundamental properties of epileptogenesis. We are instead looking at drugs that work on seizures. Nonetheless, this is very important because symptomatic treatment is what prevents seizures in the majority of people.
The other important meeting for me is the Antiepileptic Drug Trials Conference, which is held in Florida in alternate years with the Eilat Conference. The most important features of these 2 meetings are to assess the progress of the various new drugs for epilepsy. Some of the meetings also include discussions about devices, but the Eilat meeting is exclusively devoted to drugs, and it is pharmacology-dominated and very sophisticated in many ways. It is a quick but very thorough update on what is happening with new drugs for seizure disorders.
Dr. Wilner: Several new drugs have been approved in the past 15 years. Yet, we often hear that epilepsy remains uncontrolled in 30% of people with the disease, and that number has not changed much despite the new drugs. Can you provide some perspective on these developments?
Dr. Porter: Yes. This is a bit of an enigma. We know that it is much more difficult, for example, to recruit patients for clinical trials now than it was in 1980, when I was conducting clinical trials on complex partial seizures. This is the most common type of seizure type in adults for which we conduct clinical trials. Today, it is much more difficult to find patients with poorly controlled complex partial seizures. One usually has to go to several other countries and even continents to find the number of sites necessary to recruit the participants that are required for these trials.
Dr. Wilner: That suggests that patients may have better outcomes now, but we do not have good statistics on this.
Dr. Porter: Correct. We do not have good statistics on this.
Trial design bears some responsibility too. For example, if we require patients to have 3 seizures a month to participate in a given clinical trial, and a new drug comes along that reduces seizure activity to 1 per month, the patients still consider their disease to be uncontrolled. Indeed, it is uncontrolled; the patients cannot drive, for example. But they are also now unable to participate in the clinical trial because they no longer meet the stringent criteria that we require.
Dr. Wilner: On the basis of your experience and what you have heard at this meeting, what is the best way to move forward to find drugs that will eliminate seizures in people with epilepsy?
Dr. Porter: We must pursue 2 fundamental processes and 2 parallel tracks. The number-1 basic science issue is the need to expand our knowledge about epileptogenesis. That is not what this meeting is about. This meeting is about symptomatic therapies, which is track number 2. It is equally important to keep up the momentum to find new drugs to stop seizures so that patients can live normal lives, whenever possible. Ninety percent of the new drugs discussed at this meeting came through the NINDS (National Institute of Neurological Disorders and Stroke) Screening Program. That screening program is absolutely critical for us to continue this second track of discovering symptomatic therapies.
Dr. Wilner: That is a government-funded program?
Dr. Porter: That is exactly right. This comes from the National Institutes of Health. It costs only about $3 million per year, but in the past 30 or 40 years, they have found about 9 drugs, and these drugs have revolutionized the way that patients are treated today for their epileptic conditions.
Dr. Wilner: You are Chief Scientific Officer of The Epilepsy Therapy Project. What is the Epilepsy Therapy Project?
Dr. Porter: The Epilepsy Therapy Project is a nonprofit organization devoted to finding new therapies, and our job is to find funding for potential new therapies that might not be funded by the usual mechanisms at the National Institutes of Health. We fund development of devices and early drug studies; we try to find therapies that are close to marketing. We have a limited budget, but we are growing and hoping to be more effective in the future.
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