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Merck to file NDA for potential first-in-class insomnia therapy

Monday, February 06 2012 | Comments
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Merck & Co. Inc. plans to file a New Drug Application (NDA) with the Food and Drug Administration later this year for suvorexant, a potential first-in-class treatment for insomnia. Merck's decision to proceed with the NDA was based on positive results from two pivotal Phase III trials of suvorexant. Each of these randomized, double-blind studies compared suvorexant with placebo in more than 1,000 adults with primary insomnia. The primary outcome measures of both trials were the changes...

Merck & Co. Inc. plans to file a New Drug Application (NDA) with the Food and Drug Administration later this year for suvorexant, a potential first-in-class treatment for insomnia.

Merck's decision to proceed with the NDA was based on positive results from two pivotal Phase III trials of suvorexant.

Each of these randomized, double-blind studies compared suvorexant with placebo in more than 1,000 adults with primary insomnia. The primary outcome measures of both trials were the changes from baseline in subjective total sleep time, wake time after persistent sleep onset, subjective time to sleep onset and latency to onset of persistent sleep, all of which were assessed at months one and three. The primary outcome analysis focused on differences between the highest dose of suvorexant administered (40 mg) and placebo.

Suvorexant has also been evaluated in a long-term, Phase III study in which the drug's safety was evaluated in more than 700 patients during a treatment period of as long as 14 months. Primary outcome measures of this trial included the proportions of patients who experienced narcolepsy-like events, complex sleep-related behavior, falls and suicidal ideation and/or behaviors.

Merck said the suvorexant NDA is one of five "major U.S. filings" the firm has planned for 2012 and 2013.

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Lundbeck sells three injectables to Akorn Verusmed

Thursday, December 29 2011 | Comments
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Akorn Inc.'s Oak Pharmaceuticals Inc. subsidiary purchased three off-patent, branded, hospital-based injectables from Lundbeck Inc.

Lundbeck said it divested the products as part of its long-term strategy to focus on "newer, strategic products" in its pipeline.  

The three products--Nembutal (pentobarbital sodium), Diuril...

Tags: Insomnia


New study shows no link between insomnia, incident hypertension in older adults Verusmed

Tuesday, February 17 2009 | Comments
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New data do not support the notion that insomnia increases the risk of developing hypertension in older adults. In fact, findings from the study actually showed a reduced risk of incident hypertension among nonblack men who reported difficulty initiating sleep at baseline.

The study researchers hypothesized that insomnia complaints would predict the development of hypertension, particularly among black individuals. They cited a longitudinal analysis that revealed a link between...

Tags: Insomnia


Poor sleep independently predicts quality of life in MS, data reveal Verusmed

Wednesday, January 28 2009 | Comments
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Poor sleep is common among individuals with multiple sclerosis (MS), it is associated with greater disability and comorbidity, and it is an independent predictor of worse quality of life (QOL), according to findings from a study conducted in Italy.

The goals of the study were to better characterize the following: the prevalence of poor sleep in MS, the effect of demographic, socioeconomic, and clinical characteristics on sleep in these patients, and the association between...

Tags: Multiple Sclerosis, Insomnia


Insomnia creates large economic burden, Canadian study indicates Verusmed

Wednesday, January 28 2009 | Comments
Evidence Grade 0 What's This?

Results of a Canadian study contribute to a growing body of research suggesting that insomnia creates a substantial economic burden for society, with data revealing annual direct and indirect costs (from a societal perspective) totaling approximately $5.38 billion for the province of Quebec, at the current exchange rate--equivalent to approximately 1% of the province's gross domestic product in 2002.

For the study, researchers used data collected from a survey of 948 adults...

Tags: Insomnia




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