Zileutton is already in tthe market ?
Can we take it?

--- "Dr. Geoffrey Nase, PhD" <drnase1000@...>
escribió:
>
>
>
> Zieluton – More than an acne treatment
>
> Zileuton is now broadening its treatment indications
> for other
> inflammatory skin disorders including rosacea.
> Zileuton can be
> taken long term, has no harmful effect on
> non-asthmatics, reduces
> sebum by about 65%, shrinks sebaceous glands and
> decreases
> inflammatory lesions by about 75% in just 3 months.
>
> More importantly, Leukotriene B4 (which is the main
> substance
> blocked by zileuton) is (1) a strong dilator in the
> skin (patients
> report significant decreases in facial skin warmth
> while on the
> medication), (2) one of the most important initial
> causes of
> swelling, and (3) is one of the primary substances
> that binds to
> sensory nerve fibers in the facial skin to increase
> the sensation of
> pain and burning in the skin. Critical
> therapeutics, the makers of
> zileuton need to be made aware of the great promise
> this oral drug
> has for rosacea.
>
> Below is just an update on its actions on acne,
> sebum and
> inflammatory papules.
>
> Geoffrey
> ______________________________
>
> Dr. Geoffrey Nase
> Ph.D. Neurovascular Physiologist
> http://www.drnase.com
> ______________________________
>
>
>
>
> Critical Therapeutics to Begin Phase II Study of
> Zileuton for
> Moderate to Severe Acne
>
> Efficacy and Safety Trial to be Conducted in up to
> 90 Patients
>
> LEXINGTON, Mass., Oct. 5, 2004--Critical
> Therapeutics, Inc. (Nasdaq:
> CRTX ), a biopharmaceutical company focused on the
> discovery,
> development and commercialization of products for
> respiratory,
> inflammatory and critical care diseases, today
> announced that it
> will begin enrolling patients in a Phase II clinical
> study this
> month to assess the efficacy and safety of Zyflo®,
> the tablet
> formulation of zileuton, in patients with moderate
> to severe acne.
>
> "By focusing on the role of inflammatory mediators
> in the
> pathogenesis of acne, our goal is to identify new
> therapeutic
> approaches to treat a major factor in the
> progression of this
> disease," said the study's principal investigator,
> Diane M.
> Thiboutot, M.D., professor of dermatology at Penn
> State Milton S.
> Hershey Medical Center/Penn State University College
> of
> Medicine. "Today, patients with moderate to severe
> acne have limited
> treatment options, so there is an established need
> for treatment
> alternatives with the potential to help manage this
> disease."
>
> The double-blind, randomized, placebo-controlled
> Phase II study will
> consist of two groups of approximately 45 patients
> each, with the
> active drug group receiving Zyflo tablets for 12
> weeks. The 30-day
> waiting period related to the investigational new
> drug submission
> for this study ended September 16, 2004 and patient
> dosing is
> scheduled to begin this month at multiple centers in
> the United
> States. The study is expected to be completed in the
> first half of
> 2005. Acne affects approximately 17 million people
> in the United
> States, according to the American Academy of
> Dermatology. The
> leading branded therapy for acne generated peak
> sales in excess of
> $500 million despite carrying a restrictive label.
>
> Zyflo was approved by the U.S. Food and Drug
> Administration (FDA) in
> 1996 for the treatment of asthma in patients 12 and
> older. Zyflo
> blocks the activity of 5 lipoxygenase (5-LO), the
> enzyme chiefly
> responsible for producing a range of inflammatory
> mediators known as
> leukotrienes, which are believed to play a central
> role in tissue
> inflammation related to asthma, acne and other
> diseases.
>
> Leukotriene B4, which can be blocked by zileuton,
> has been shown to
> promote the production of skin surface oils known as
> sebum lipids.
> Key findings of a zileuton pilot study in acne
> included a 65% mean
> reduction of sebum lipids at 12 weeks (p=0.04) and a
> mean reduction
> in inflammatory lesions of 71% at 12 weeks
> (p=0.007). There was also
> a significant reduction in the acne severity index
> as early as 4
> weeks (p is less than 0.05). Results from this study
> were published
> in the May 2003 edition of the Archives of
> Dermatology.
>
> "The initiation of this trial is an important step
> in our strategy
> to broaden the market opportunities for zileuton,"
> said Paul Rubin,
> M.D., president and chief executive officer of
> Critical
> Therapeutics. "The focus of our Phase II trial will
> be to confirm
> the findings in that pilot study and then advance
> into a pivotal
> Phase III study."
>
> Critical Therapeutics acquired from Abbott
> Laboratories the
> worldwide rights to develop and market Zyflo for
> asthma. Critical
> Therapeutics also acquired worldwide rights to other
> formulations of
> zileuton for multiple disease and conditions
> including asthma, acne,
> chronic obstructive pulmonary disease and nasal
> polyps.
>
>
>
>
>
>
>
>
>
> --
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>
>
>
>



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