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NEW TREATMENTS FOR EPILEPSY
Sat, 08/30/2008 - 15:34Did you know how long it takes for a new treatment for epilepsy to be tested and approved? The average for neurological drugs is almost 13 years from the first testing in humans to FDA approval and availability at your local pharmacy. Why does it take so long? We understand that testing requires very careful evaluation of safety as well as determination that the treatment is effective. This requires several stages of clinical trials, each lasting several years.
Did you know that you can improve this timeline? The biggest roadblock in testing new treatments is finding patients willing to participate in clinical trials. It’s not easy to find patients who are eligible for these studies so the recruitment phase often lasts more than two years for each clinical trial. Testing new treatments usually is done by asking patients who have many seizures and have already tried many drugs to enroll with the opportunity to receive either the new treatment added onto current therapy or a placebo added onto current therapy. Most studies are brief, lasting only three to four months, after which all patients are offered the new treatment. Therefore, people who received the placebo initially can have a new therapy after this brief introductory phase.
Why does it take so long to find people who are having many seizures when there are millions of people with epilepsy? Clinical trials must be limited to people with specific types of seizures, minimum frequency of seizures (usually at least four partial-onset seizures per month), and be in excellent health. In addition, patients must be willing to visit the study center frequently during the follow-up period for free care. Not every doctor can and enroll patients into every clinical trial, so people willing to participate in studies must be referred to the doctor in their area who is conducting the clinical trial. Although patients are followed by the study doctor for the duration of the clinical trial, they return to their own doctor at the conclusion of the study.
What can you do to help speed the development of new treatments for epilepsy? Enrolling in a clinical trial for which you are eligible might provide you with improved seizure control and certainly will help others when we understand the usefulness of a new treatment. The first place to look for a clinical trial is on our website at http://my.epilepsy.com/clinical_trials where you can find studies being conducted in your area. A video in which I interview Dr. Morrell provides a description of a clinical trial of the RNS Neurostimulator may be seen at http://my.epilepsy.com/node/976507 . This brain stimulating device is being tested with adults who have frequent partial-onset seizures at 29 centers across the
Success! Retigabine is an example of a new antiepileptic drug that has been tested in clinical trials since 1997 over the years: Enough testing has been completed with retigabine to be ready to request approval by the FDA. Almost 1600 patients participated in these studies over the years. It will take another year before we take a being is in your pharmacy, if approved as expected.
I am excited to see another antiepileptic drug move toward approval so the epilepsy community will have another treatment for seizures. I also am pleased to see that two companies (Valeant and Glaxo Smith Kline) will share in developing this compound to make it available around the world. I look forward to additional epilepsy treatments (drugs and brain stimulating devices) being approved in the near future. We need even more therapies to help those who have not yet achieved seizure control.
Wishing everyone “freedom from seizures” as soon as possible,
President, Epilepsy Therapy Project
Comments
Re: NEW TREATMENTS FOR EPILEPSY
Submitted by President on Sun, 2009-04-12 - 16:56
Our seed funding is an example of
President, Epilepsy Therapy Project
President, Epilepsy Therapy Project
Re: NEW TREATMENTS FOR EPILEPSY
Submitted by President on Sat, 2009-01-10 - 14:47
However, after several years, doctors discovered that some patients had decreases in peripheral (side) vision. When this happens, people lose the ability to see around the edges of their eye; their range of vision becomes more central. However, people often do not notice the changes because they accommodate by turning their heads slightly to see what is on the side. That news greatly decreased the number of patients starting VGB, largely restricting its use to people who had not be controlled on several other drugs (considered treatment-resistant).
Over the years, VGB has been reviewed and disapproved three times by FDA for use in theThe discussion for treatment of partial-onset epilepsy centered on the risk of visual field deficits that occur in more than a quarter of patients who take the drug long-term. Despite years of experience with VGB, we do not know who will be affected or how rapidly it occurs. Testing requires a lot of cooperation by the patient making it impossible for those have limited capacity to understand the instructions and stay still throughout testing. Although visual field deficits also are a concern for babies with infantile spasms, the urgency for rapid treatment may outweigh the risk for limited vision in later life. Babies also are treated for shorter periods than adults with partial-onset seizures. I noted suggested that adults should be given the opportunity to try vigabatrin for 3 months and babies for 2-3 weeks to determine whether their seizures improve. If not, the drug would be stopped with little risk of visual problems after brief treatment. Give people freedom to choose!
After extensive discussion of the risks and benefits of treatment, the Advisory Committee voted unanimously to recommend approval of vigabatrin (Sabril) for the treatment of refractory partial-onset seizures and infantile spasms, with a special safety monitoring program. I am delighted that Americans will have access to this useful medication.
This is one of the ways in which Epilepsy Therapy Project supports new treatments for people with epilepsy. We start with grant support to scientists, seed investments to start-up companies, advising investors, matchmaking between entrepreneurs and venture capital groups, and presentations of therapies in development (the “pipeline”) to showcase the future. When you make a donation toETP , these are the activities you support. Thank you!
Wishing you a seizure-free year in 2009,FDA Review of vigabatrin (Sabril®) I am starting the year by participating in the FDA Advisory Board review of vigabatrin (VGB)(Sabril®). The FDA expert panel considered whether the drug is effective and safe for treatment of (a) partial onset seizures and (b) infantile spasms, on sequential days. It is important to note that VGB has been in use in countries for more than a decade around the world except USA . When first tested for partial onset seizures, it was considered highly valuable at a time when few other drugs were available in the early 1980s. Doctors soon noticed that it also was highly effective in treating babies with infantile spasms, a severe form of epilepsy that often leads to slow development and lifelong seizures.
However, after several years, doctors discovered that some patients had decreases in peripheral (side) vision. When this happens, people lose the ability to see around the edges of their eye; their range of vision becomes more central. However, people often do not notice the changes because they accommodate by turning their heads slightly to see what is on the side. That news greatly decreased the number of patients starting VGB, largely restricting its use to people who had not be controlled on several other drugs (considered treatment-resistant).
Over the years, VGB has been reviewed and disapproved three times by FDA for use in theThe discussion for treatment of partial-onset epilepsy centered on the risk of visual field deficits that occur in more than a quarter of patients who take the drug long-term. Despite years of experience with VGB, we do not know who will be affected or how rapidly it occurs. Testing requires a lot of cooperation by the patient making it impossible for those have limited capacity to understand the instructions and stay still throughout testing. Although visual field deficits also are a concern for babies with infantile spasms, the urgency for rapid treatment may outweigh the risk for limited vision in later life. Babies also are treated for shorter periods than adults with partial-onset seizures. I noted suggested that adults should be given the opportunity to try vigabatrin for 3 months and babies for 2-3 weeks to determine whether their seizures improve. If not, the drug would be stopped with little risk of visual problems after brief treatment. Give people freedom to choose!
After extensive discussion of the risks and benefits of treatment, the Advisory Committee voted unanimously to recommend approval of vigabatrin (Sabril) for the treatment of refractory partial-onset seizures and infantile spasms, with a special safety monitoring program. I am delighted that Americans will have access to this useful medication.
This is one of the ways in which Epilepsy Therapy Project supports new treatments for people with epilepsy. We start with grant support to scientists, seed investments to start-up companies, advising investors, matchmaking between entrepreneurs and venture capital groups, and presentations of therapies in development (the “pipeline”) to showcase the future. When you make a donation toETP , these are the activities you support. Thank you!
Wishing you a seizure-free year in 2009,