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Biotech / Medical : Biotech Valuation
CRSP 55.11-2.6%Nov 7 9:30 AM EST

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To: Biotech Jim who wrote (20095)5/20/2006 11:51:06 AM
From: Brander  Read Replies (2) of 52153
 
<<The closest are melatonin and Rozerem, but these only help in 25-30% of those that try it>>

>I would like to see the scientific underpinnings of your statement:<

The results were presented at the 2006 Annual Meeting of the American Academy of Neurology (AAN).

In this placebo-controlled analysis, approximately two-thirds of patients who received 8 mg of Rozerem experienced at least a 50% reduction in the time it took them to fall asleep. Study participants also experienced no rebound insomnia or withdrawal effects following discontinuation of treatment with Rozerem.

In this sub-analysis of a large, double-blind, placebo-controlled study, a total of 269 adults received 8 mg of Rozerem (n=138) or placebo (n=131) nightly for five weeks (35 nights). Sleep parameters were evaluated at weeks 1, 3, and 5 by using a polysomnograph. Rozerem was replaced with placebo for the two nights following the study (nights 36 and 37) to evaluate rebound insomnia and withdrawal effects.

The primary endpoint was the percentage of patients who achieved at least 50% improvement in the time it took to fall asleep (latency to persistent sleep, or LPS).

Results showed that a statistically significantly greater percentage of adults with chronic insomnia treated with Rozerem 8 mg demonstrated at least 50% LPS reduction compared to those who received placebo at week 1 (63% vs. 40% (P <.001)).

Those results were sustained throughout the study (63% vs. 41% at week 3 (P <.001); 66% vs. 48% at week 5 (P <.005)).

The analysis revealed no evidence of rebound insomnia or withdrawal for patients taking Rozerem as measured by the BWSQ. Adverse events were similar in both groups, with somnolence, fatigue and headache being the only events reported in 5% or more of patients in either group. This incidence was similar to that seen in other clinical studies.

As far as my estimate, that Rozerem and melatonin are helpful about 25-30% of those that try it, that comes from my own clinical experience, which includes working with thousands of people who have insomnia over the years.

Not to make this a sleep disorder thread, but there is a subgroup of people with insomnia that respond well to the drugs that work on the melatonin receptors, and their side effect profile and non abuse characteristics make them worth a try.
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