http://hometown.aol.com/path2pub/pubpol/xyrem7.htm
Did anyone else nkow about this? Apperantly this company is trying to get FDA approval on GHB used in treatment of narcolepsy. This somewhat confuses me. I would thing that GHB would a good treatment for insomnia.
Of all the schedule I drugs that I can think of, GHB is definatey one of the ones that has extremely high therapeutic/medicinal value. It's good to see that someone (Orphan Medical, Inc) agrees.
Below is an interview with a representative of the manudfacturer I guess. Notice the answer about dosage. That's huge, isn't it?
Dr. Jed Black, Director of the Stanford Sleep Disorders Center, was involved in the clinical trials for Xyrem, and answers our questions in the brief interview below:
TalkAboutSleep: Orphan's new drug Xyrem treats the symptoms of narcolepsy. Which symptoms does it treat? What is the impact on those symptoms?
Dr. Black: Xyrem improves cataplexy, daytime alertness and nocturnal sleep. Improvement in any of these areas is often dramatic.
TalkAboutSleep: How does Xyrem work?
Dr. Black: Xyrem's mechanism of action in narcolepsy symptoms is unclear. One component of its activity may be to improve the restorative nature of nocturnal sleep and thereby reduce symptom severity.
TalkAboutSleep: What is a typical dosage of Xyrem? How is it given?
Dr. Black: Xyrem is dosed in liquid form ranging from approximately 4-5 gram per night to 9-10 grams per night.
TalkAboutSleep: Are there any side-effects to Xyrem of any significance?
Dr. Black: Xyrem is taken at night because it causes marked sedation. The sedation can last up to 4 hours or so in the higher doses. Other occasional side effects can occur, but usually resolve after dosing for a week or two.
TalkAboutSleep: Who is a good candidate for Xyrem? Every narcolepsy patient? Or only some patients?
Dr. Black: Any patient with cataplexy requiring medication treatment is a potential candidate for Xyrem therapy. Studies are currently underway to determine Xyrem's effect on sleep and daytime sleepiness in a placebo-controlled fashion.
TalkAboutSleep: Since Xyrem treats EDS as well as cataplexy, is there any indication that Xyrem could be useful in treating EDS alone, that is, in patients without narcolepsy?
Dr. Black: Pilot studies have suggested that Xyrem may reduce EDS and larger, controlled studies are underway. Certainly we have seen substantial improvement in sleepiness in many of our patients treated with Xyrem.
[ 22 December 2001: Message edited by: Effigy ]
Did anyone else nkow about this? Apperantly this company is trying to get FDA approval on GHB used in treatment of narcolepsy. This somewhat confuses me. I would thing that GHB would a good treatment for insomnia.
Of all the schedule I drugs that I can think of, GHB is definatey one of the ones that has extremely high therapeutic/medicinal value. It's good to see that someone (Orphan Medical, Inc) agrees.
Below is an interview with a representative of the manudfacturer I guess. Notice the answer about dosage. That's huge, isn't it?
Dr. Jed Black, Director of the Stanford Sleep Disorders Center, was involved in the clinical trials for Xyrem, and answers our questions in the brief interview below:
TalkAboutSleep: Orphan's new drug Xyrem treats the symptoms of narcolepsy. Which symptoms does it treat? What is the impact on those symptoms?
Dr. Black: Xyrem improves cataplexy, daytime alertness and nocturnal sleep. Improvement in any of these areas is often dramatic.
TalkAboutSleep: How does Xyrem work?
Dr. Black: Xyrem's mechanism of action in narcolepsy symptoms is unclear. One component of its activity may be to improve the restorative nature of nocturnal sleep and thereby reduce symptom severity.
TalkAboutSleep: What is a typical dosage of Xyrem? How is it given?
Dr. Black: Xyrem is dosed in liquid form ranging from approximately 4-5 gram per night to 9-10 grams per night.
TalkAboutSleep: Are there any side-effects to Xyrem of any significance?
Dr. Black: Xyrem is taken at night because it causes marked sedation. The sedation can last up to 4 hours or so in the higher doses. Other occasional side effects can occur, but usually resolve after dosing for a week or two.
TalkAboutSleep: Who is a good candidate for Xyrem? Every narcolepsy patient? Or only some patients?
Dr. Black: Any patient with cataplexy requiring medication treatment is a potential candidate for Xyrem therapy. Studies are currently underway to determine Xyrem's effect on sleep and daytime sleepiness in a placebo-controlled fashion.
TalkAboutSleep: Since Xyrem treats EDS as well as cataplexy, is there any indication that Xyrem could be useful in treating EDS alone, that is, in patients without narcolepsy?
Dr. Black: Pilot studies have suggested that Xyrem may reduce EDS and larger, controlled studies are underway. Certainly we have seen substantial improvement in sleepiness in many of our patients treated with Xyrem.
[ 22 December 2001: Message edited by: Effigy ]
