Vanda's Sleep Disorder Drug Tasimelteon Shows Promise

[bananas]

Source: Medical News Today

The experimental drug tasimelteon has passed it's second late-stage trial with surprisingly good results, showing the effectiveness of the drug in treating a rare condition called non-24-hour sleep-wake disorder (non-24).

Non-24 is a serious cicardian rhythm sleep disorder characterized by hourly delays in sleep onset and wake times due to a person's body clock not properly adjusting to the light/dark cycle. This results in people being unable to sleep at night and then feeling exhausted and tired during the day. It is a somewhat rare disorder, only affecting an estimated 1 in every 2,000 people - although quite common among blind people. As of yet, there isn't any approved form of treatment.

The drug developed by Vanda regulates the circadian rhythm, acting as a melatonin agonist. It works by resetting a person's master body clock in the hypothalamus, which stabilizes the melatonin and cortisol rhythms to a regular 24-hour day-night cycle.

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According to Steven W. Lockley, Ph.D., Division of Sleep Medicine, Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School:

"These results clearly demonstrate that tasimelteon can entrain the circadian clock and continued treatment is necessary to maintain entrainment. The study also shows that entrainment is associated with meaningful clinical benefits and that maintaining entrainment of the master body clock is critical to treating the problems caused by Non-24."

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Read more: http://www.medicalnewstoday.com/articles/255304.php

[bananas]

1. Reuters: Vanda sleep drug effective in second late-stage trial

http://www.reuters.com/article/2013/01/23/us-vanda-trial-sleepdrug-idUSBRE90M0NP20130123

Vanda sleep drug effective in second late-stage trial

Wed Jan 23, 2013 7:49am EST

(Reuters) - Vanda Pharmaceuticals Inc said its experimental drug for a rare sleep disorder proved effective in a second late-stage trial, and the company now plans to apply for a U.S. approval for the drug in mid-2013.

The study, named Reset, was a 20-patient trial designed to test the maintenance effect of a 20 mg dose of the drug, tasimelteon.

Vanda on December 18 said the drug performed better than a placebo in the first of the four planned late-stage trials on the drug. The company's shares rose as much as 37 percent on that day.

While the first two are efficacy studies, the remaining two are intended to establish the safety profile of the drug.

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[bluevoter4life]

2. This is good news

For people who do shift work, especially those in the transportation industries. Pilots, air traffic controllers, truck drivers, ship workers, etc could really benefit from this development.

[bananas]

8. Also astronauts, jet lag, and sundowners.

The implications for astronauts and jet laggers should be obvious.
The implications for the rest of is much more subtle.
My mother had this, it was like a switch being flipped at sundown:

http://en.wikipedia.org/wiki/Sundowning

Sundowning is a psychological phenomenon associated with increased confusion and restlessness in patients with some form of dementia. Most commonly associated with Alzheimer's disease, but also found in those with mixed dementia, the term "sundowning" was coined due to the timing of the patient's confusion. For patients with sundowning syndrome, a multitude of behavioral problems begin to occur in the evening or while the sun is setting.[1][2] [3] Sundowning seems to occur more frequently during the middle stages of Alzheimer's disease and mixed dementia. Patients are generally able to understand that this behavioral pattern is abnormal. Sundowning seems to subside with the progression of a patient's dementia.[1][2] Research shows that 20–45% of Alzheimer's patients will experience some sort of sundowning confusion.[1]

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[msanthrope]

3. I have this disorder. It is hell. nt

[bananas]

5. +1000. nt

[harmonicon]

7. Just curious...

but how were you diagnosed?

I've had insomnia for almost my entire life, and from this short description, that's what it sounds like - I never thought that there was some name for my type. Any time I've asked a doctor about it, they've been reluctant to have me take sleeping pills, because most of them are for short-term ailments, not a life-long condition, so I've just found ways to deal with it, more-or-less.

[msanthrope]

9. I'm in Philly so I went to Jefferson Sleep Clinic. I would suggest you visit one for a study.

its worth going to a sleep clinic.

[McCamy Taylor]

4. Now comes the "off label" use for any form of insomnia.

No company can recoup its costs on a 1 in 2000 disorder. They plan to sell it as the new, more expensive melatonin---which will mean that the FDA will have to be pushed to ban melatonin. As a melatonin user, I plan to stock up.

[REP]

6. I saw this as Vanda tassellata

And wondered if a new use for an orchid was found (we use them every day to flavor food).

Oops.