First I feel that I need to apologize for not posting for a short time. I am not young and have several health issues.
I noticed that the link I had posted for Pagoclone no longer worked. I changed it to these about the study (Indevus is the manufacturer):
http://www.stutteringhelp.org/default.aspx?tabindex=515&tabid=525
https://online2.americanmediconnect.com/Stuttering_Study/default.aspx
http://www.indevus.com/site/index.php?option=com_content&task=view&id=31&Itemid=45
Showing posts with label Drugs. Show all posts
Showing posts with label Drugs. Show all posts
Pagoclone
I found this on http://www.marketwatch.com/ today:
Indevus Announces Agreement With Teva to Develop Pagoclone for the Treatment of Stuttering
10:30 a.m. EDT Sept. 26, 2008
Indevus announced that it has signed a development, license and commercialization agreement with Teva Pharmaceutical Industries Ltd. for the exclusive, worldwide rights to pagoclone. Indevus previously announced promising data from its 8-week, placebo controlled, double-blind, multi-center Phase II trial in patients with persistent stuttering which showed that pagoclone produced a statistically significant benefit in multiple primary and secondary stuttering endpoints compared to placebo. Pagoclone is a novel member of the cyclopyrrolone class of compounds and acts as a gamma amino butyric acid (GABA) selective receptor modulator.
Under the terms of the Agreement, which is subject to applicable regulatory clearances and customary conditions, Indevus will conduct and Teva will reimburse Indevus for its expenses for a Phase IIb study. The placebo- controlled study will involve approximately 300 patients with stuttering in the U.S. treated for a period of six months and is expected to commence enrollment by the first quarter of 2009.
If the arrangement continues, Teva will be responsible for the conduct of the Phase III program.
"There are currently no approved drugs anywhere in the world for patients with stuttering. Pagoclone has tremendous potential to become a highly significant commercial product, as well as to provide a ground-breaking therapy to the nearly three million Americans and millions of patients around the world who are afflicted with this condition. The deal we have negotiated with Teva allows us to conduct a definitive Phase IIb trial, funded by our partner. If the trial is positive, we believe that both companies will have a unique opportunity to commercialize the first pharmaceutical product for the millions of patients who stutter."
About Pagoclone
Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor agonist. In clinical studies in anxiety disorders, it has been shown to reduce the symptoms of panic disorder and generalized anxiety disorder without causing the sedation or withdrawal effects seen with benzodiazepine agents. Pagoclone trials have enrolled over 1,500 patients to date. In early 2005, Indevus was granted a new U.S. patent covering the use of pagoclone for the treatment of stuttering.
Read the full story here: http://www.marketwatch.com/news/story/indevus-announces-agreement-teva-develop/story.aspx?guid=%7BD1C01E20-BB6C-479C-94F7-909C41AA72EF%7D&dist=hppr
Indevus Announces Agreement With Teva to Develop Pagoclone for the Treatment of Stuttering
10:30 a.m. EDT Sept. 26, 2008
Indevus announced that it has signed a development, license and commercialization agreement with Teva Pharmaceutical Industries Ltd. for the exclusive, worldwide rights to pagoclone. Indevus previously announced promising data from its 8-week, placebo controlled, double-blind, multi-center Phase II trial in patients with persistent stuttering which showed that pagoclone produced a statistically significant benefit in multiple primary and secondary stuttering endpoints compared to placebo. Pagoclone is a novel member of the cyclopyrrolone class of compounds and acts as a gamma amino butyric acid (GABA) selective receptor modulator.
Under the terms of the Agreement, which is subject to applicable regulatory clearances and customary conditions, Indevus will conduct and Teva will reimburse Indevus for its expenses for a Phase IIb study. The placebo- controlled study will involve approximately 300 patients with stuttering in the U.S. treated for a period of six months and is expected to commence enrollment by the first quarter of 2009.
If the arrangement continues, Teva will be responsible for the conduct of the Phase III program.
"There are currently no approved drugs anywhere in the world for patients with stuttering. Pagoclone has tremendous potential to become a highly significant commercial product, as well as to provide a ground-breaking therapy to the nearly three million Americans and millions of patients around the world who are afflicted with this condition. The deal we have negotiated with Teva allows us to conduct a definitive Phase IIb trial, funded by our partner. If the trial is positive, we believe that both companies will have a unique opportunity to commercialize the first pharmaceutical product for the millions of patients who stutter."
About Pagoclone
Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor agonist. In clinical studies in anxiety disorders, it has been shown to reduce the symptoms of panic disorder and generalized anxiety disorder without causing the sedation or withdrawal effects seen with benzodiazepine agents. Pagoclone trials have enrolled over 1,500 patients to date. In early 2005, Indevus was granted a new U.S. patent covering the use of pagoclone for the treatment of stuttering.
Read the full story here: http://www.marketwatch.com/news/story/indevus-announces-agreement-teva-develop/story.aspx?guid=%7BD1C01E20-BB6C-479C-94F7-909C41AA72EF%7D&dist=hppr
Drugs for Stuttering
"A number of drugs have been reported to reduce stuttering. (1,2) One of these drugs is alprazolam (Xanax), an antianxiety agent. Included also are citalopram (Celexa), a selective serotonin reuptake inhibitor, and clomipramine (Anafranil), another strongly serotonergic drug. All three of three of these agents reduce stuttering in selective patients. However, only a minority of patients who stutter respond with increased fluency to any of these drugs. Those who do respond usually show only a very modest reduction in stuttering. We believe that adults with severe stuttering may require two medications, one directed at each component of the disorder.
To test this hypothesis, we undertook the treatment of Dr. A., a 57-year-old physician with a severe stutter since age 4 years. He scored 6 (severe stutter) on the 7-point scale for rating the severity of stuttering. (3) He had tried numerous medications and therapy programs over the years, but had obtained only minimal improvement in his speech. His response to the combination of alprazolam (1.0 mg twice daily) and citalopram (10 mg at bedtime) was prompt and dramatic. We could detect only traces of his former impediment. Family, friends, and colleagues have all spontaneously noted and remarked on his greatly increased fluency. Dr. A. reports that he now speaks out in many situations where previously he said little out of fear of stuttering. His score on the Stuttering Rating Scale decreased from 6 to 2 (mild stutter). In his 20th week of treatment, Dr. A. continued to improve. With this great reduction in stuttering, his anticipatory anxiety has greatly reduced, making it possible to gradually discontinue his alprozolam use. However, the citalopram (reducing the core symptoms of stuttering) remains necessary (20 mg at bedtime).
We have treated three additional men with severe stuttering in this manner. Two reported experiencing fewer side effects with clomipramine (100 mg at bedtime) and will continue with this agent. The third patient reported fewer side effects with citalopram (20 mg at bedtime) and will continue with this drug. All three showed marked improvement in their speech on the Stuttering Rating Scale (from 6-6.5 before treatment to 1.5-2 with treatment). All three continue to take alprazolam as well (1 mg twice daily).
References:
Brady JP. The pharmacology of stuttering: a critical review. Am J Psychiatry 1991;1448: pages 1309-16.
Brady JP, Rynn M. Stuttering: current pharmacological options. CNS Drugs 1994;1: 261-268.
Johnson W., Darley F.L., Spriesterback D.C. Scale for rating severity of stuttering.In: Diagnostic methods in speech pathology. New York: Harper and Row, 1963"
copied from The Stuttering Foundation of America page http://www.stutteringhelp.org/Default.aspx?tabid=170
To test this hypothesis, we undertook the treatment of Dr. A., a 57-year-old physician with a severe stutter since age 4 years. He scored 6 (severe stutter) on the 7-point scale for rating the severity of stuttering. (3) He had tried numerous medications and therapy programs over the years, but had obtained only minimal improvement in his speech. His response to the combination of alprazolam (1.0 mg twice daily) and citalopram (10 mg at bedtime) was prompt and dramatic. We could detect only traces of his former impediment. Family, friends, and colleagues have all spontaneously noted and remarked on his greatly increased fluency. Dr. A. reports that he now speaks out in many situations where previously he said little out of fear of stuttering. His score on the Stuttering Rating Scale decreased from 6 to 2 (mild stutter). In his 20th week of treatment, Dr. A. continued to improve. With this great reduction in stuttering, his anticipatory anxiety has greatly reduced, making it possible to gradually discontinue his alprozolam use. However, the citalopram (reducing the core symptoms of stuttering) remains necessary (20 mg at bedtime).
We have treated three additional men with severe stuttering in this manner. Two reported experiencing fewer side effects with clomipramine (100 mg at bedtime) and will continue with this agent. The third patient reported fewer side effects with citalopram (20 mg at bedtime) and will continue with this drug. All three showed marked improvement in their speech on the Stuttering Rating Scale (from 6-6.5 before treatment to 1.5-2 with treatment). All three continue to take alprazolam as well (1 mg twice daily).
References:
Brady JP. The pharmacology of stuttering: a critical review. Am J Psychiatry 1991;1448: pages 1309-16.
Brady JP, Rynn M. Stuttering: current pharmacological options. CNS Drugs 1994;1: 261-268.
Johnson W., Darley F.L., Spriesterback D.C. Scale for rating severity of stuttering.In: Diagnostic methods in speech pathology. New York: Harper and Row, 1963"
copied from The Stuttering Foundation of America page http://www.stutteringhelp.org/Default.aspx?tabid=170
Homeopathic meds
Beware of anyone telling you to use homeopathic meds for stuttering! Some of the ones that might be suggested include gelsemium, aconite, and stramonium. Doing some research on these will reveal some interesting information.
Here's a paragraph of a lady describing what gelsemium did to her:
"A few moments after taking the medicine there is an extreme feeling of restlessness - not able to be still for a second, keep turning and twisting all the time. This is succeeded by intense pain over the right eye, always the right; it seems as if my forehead would come right over my eyes and close them; my eyes feel as if they were turning into my head, roll up all the time. Then a strong inclination to commit suicide. Want to throw myself from a height; invariably think of going to the window and dashing myself down - feel as if it would be a relief. This is succeeded by an inclination to weep, and I generally have a good cry, but before I cry and while the feeling lasts of wishing to throw myself from a height, I clench my hands, and nervous rigors or sensations run all over my body down to my fingers and toes; it seems as if I would lose my senses. Then a great dread of being alone seizes me, and I am afraid of what may happen; think I may lose all self-control. The pain still continues over the right eye, and often the back part of my head seems to have a spot about four inches square that is turning to ice. These feelings are followed by a strong inclination to talk or write, very great exhilaration, and a better opinion of my mental capacity - indeed it seems as if my memory was better, that I can recall almost anything I ever read; nearly always repeat long passages of something to myself that I have read years before. It appears to me that I can remember almost anything I love to recall. Now this is my invariable experience whenever I take Gelsemium no matter whether in the 3rd or 1,000th potency and I have been in the habit of using it for twenty years. I am writing this under the influence of the drug. I could not give the symptoms so accurately at any other time. As I am getting over the effects of the drug I have to urinate every few minutes. While suffering I like to have people in the room - have a perfect horror of being alone."
Here is what I found on aconite:
"All the species contain an active poison Aconitine, one of the most formidable poisons which have yet been discovered: it exists in all parts of the plant, but especially in the root. The smallest portion of either root or leaves, when first put into the mouth, occasions burning and tingling, and a sense of numbness immediately follows its continuance. One-fiftieth grain of Aconitine will kill a sparrow in a few seconds; one-tenth grain a rabbit in five minutes. It is more powerful than prussic acid and acts with tremendous rapidity. One hundredth grain will act locally, so as to produce a well-marked sensation in any part of the body for a whole day. So acrid is the poison, that the juice applied to a wounded finger affects the whole system, not only causing pains in the limbs, but a sense of suffocation and syncope."
Wouldn't you rather stutter than have the effects of these meds?
Here's a paragraph of a lady describing what gelsemium did to her:
"A few moments after taking the medicine there is an extreme feeling of restlessness - not able to be still for a second, keep turning and twisting all the time. This is succeeded by intense pain over the right eye, always the right; it seems as if my forehead would come right over my eyes and close them; my eyes feel as if they were turning into my head, roll up all the time. Then a strong inclination to commit suicide. Want to throw myself from a height; invariably think of going to the window and dashing myself down - feel as if it would be a relief. This is succeeded by an inclination to weep, and I generally have a good cry, but before I cry and while the feeling lasts of wishing to throw myself from a height, I clench my hands, and nervous rigors or sensations run all over my body down to my fingers and toes; it seems as if I would lose my senses. Then a great dread of being alone seizes me, and I am afraid of what may happen; think I may lose all self-control. The pain still continues over the right eye, and often the back part of my head seems to have a spot about four inches square that is turning to ice. These feelings are followed by a strong inclination to talk or write, very great exhilaration, and a better opinion of my mental capacity - indeed it seems as if my memory was better, that I can recall almost anything I ever read; nearly always repeat long passages of something to myself that I have read years before. It appears to me that I can remember almost anything I love to recall. Now this is my invariable experience whenever I take Gelsemium no matter whether in the 3rd or 1,000th potency and I have been in the habit of using it for twenty years. I am writing this under the influence of the drug. I could not give the symptoms so accurately at any other time. As I am getting over the effects of the drug I have to urinate every few minutes. While suffering I like to have people in the room - have a perfect horror of being alone."
Here is what I found on aconite:
"All the species contain an active poison Aconitine, one of the most formidable poisons which have yet been discovered: it exists in all parts of the plant, but especially in the root. The smallest portion of either root or leaves, when first put into the mouth, occasions burning and tingling, and a sense of numbness immediately follows its continuance. One-fiftieth grain of Aconitine will kill a sparrow in a few seconds; one-tenth grain a rabbit in five minutes. It is more powerful than prussic acid and acts with tremendous rapidity. One hundredth grain will act locally, so as to produce a well-marked sensation in any part of the body for a whole day. So acrid is the poison, that the juice applied to a wounded finger affects the whole system, not only causing pains in the limbs, but a sense of suffocation and syncope."
Wouldn't you rather stutter than have the effects of these meds?
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