Critical Therapeutics' ZYFLO(R) Receives Distinct Classification under Medicare Prescription Drug Benefit
Thursday May 25, 8:00 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--May 25, 2006--Critical Therapeutics, Inc. (Nasdaq: CRTX - News) today announced that the Centers for Medicare and Medicaid Services (CMS) has created a unique Formulary Key Drug Type (FKDT) category for the Company's asthma drug, ZYFLO® (zileuton tablets), under guidelines developed specifically for the Medicare Prescription Drug Benefit (Part D).
This new category reflects the CMS' adoption of the United States Pharmacopeias' (USP) 2007 Model Guidelines. Under the new FKDT, ZYFLO is now categorized as a "Synthesis Inhibitor" based on its pharmacologic distinction from other anti-leukotriene compounds, including Merck's Singulair®, which are grouped together in a category known as "Receptor Antagonists." ZYFLO is the only 5-lipoxygenase (5-LO) inhibitor approved by U.S. Food and Drug Administration.
The USP Model Guidelines consist of a listing of therapeutic categories and associated pharmacologic classes that create a framework that prescription drug plans and others are encouraged to adopt as they create a drug plan formulary for patients enrolled under Medicare Part D plans. The FKDT designation for ZYFLO was one of only 23 newly added to the USP Model Guidelines for 2007.
"With ZYFLO as the only Synthesis Inhibitor under this FKDT, Critical Therapeutics has an opportunity to communicate the drug's unique positioning to Medicare plans and their patients," said Senior Vice President of Sales and Marketing, Frederick Finnegan. "Since most Medicare plans typically adopt these guidelines, the CMS classification should help to promote the availability of ZYFLO for patients whose symptoms have proven difficult to control with other asthma therapies."
About Zileuton and ZYFLO
Zileuton inhibits 5-lipoxygenase (5-LO), an enzyme that catalyzes the formation of leukotrienes from arachidonic acid. 5-LO is the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion.
ZYFLO, the immediate release tablet formulation of zileuton, blocks the formation of leukotrienes. ZYFLO is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. The recommended dose is one 600 mg tablet four times a day. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with ZYFLO can be continued during acute exacerbations of asthma. ZYFLO should be taken regularly, even during symptom-free periods.
Mild to moderate side effects associated with the use of ZYFLO are abdominal pain, upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT. As a result, the level of liver enzymes in patients treated with ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO and repeat the test on a regular basis while patients are on the medication. ZYFLO is contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal.
For full prescribing information, please visit www.crtx.com/pat_pi.html or call the Company's toll free telephone number 1-866-835-8216 to request medical information. |
