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.