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FazaClo (Clozapine) Orally Disintegrating Tablets Available in US for Patients Unresponsive to Standard Schizophrenia Treatments

PARSIPPANY, NJ -- July 21, 2004 -- Alamo Pharmaceuticals introduced itself and its unique new product FazaClo(TM) (clozapine, USP) Orally Disintegrating Tablets to the nation's psychiatrists today.

Expected to bring patients new convenience and discreet dosing options, FazaClo is the patented orally disintegrating form of a drug reserved for the management of severely ill patients with schizophrenia who fail to respond adequately to standard drug treatment for schizophrenia.

"We're confident that psychiatrists and their patients will welcome the new freedom that FazaClo orally disintegrating tablets present. No longer will clozapine patients need to locate a beverage or otherwise draw attention to their need for medication," stated psychiatrist Neal R. Cutler, MD, founder, president and CEO of the California-based company. "FazaClo is particularly convenient for active, working patients getting on with their lives."

A unique, mint flavored formulation using the proprietary OraSolv® technology licensed from CIMA LABS INC., FazaClo is Alamo Pharmaceuticals' first product to reach the market. Alamo Pharmaceuticals has several additional products in the late stages of clinical development. The company's research and development work is managed at Alamo Pharmaceuticals' Beverly Hills, California headquarters; an office for pharmaceutical operations and sales is located in Parsippany, New Jersey.

Heading up the FazaClo launch efforts is executive vice president, Paul Duffy, who formerly managed Novartis Pharmaceuticals Corporation's successful Clozaril®(1) (clozapine) marketing and sales.

"We've assembled an organization of experienced psychiatric sales specialists and systems consultants to enable Alamo Pharmaceuticals to provide psychiatrists and other mental health professionals with a complete array of support services from day one," commented Duffy. "From our state-of-the-art computerized patient registry to our highly responsive call center, we aim to take the lead when it comes to supporting FazaClo patient safety."

Because of the risk of agranulocytosis and granulocytopenia associated with the use of clozapine, Alamo Pharmaceuticals has developed a monitoring system called the FazaClo™ Patient Registry. Prescribing physicians, dispensing pharmacists and FazaClo™ (clozapine, USP) patients must be registered in the FazaClo™ Patient Registry, which will compare patient information against the National Non-Rechallenge Masterfile and maintain a continuing record of WBC values and related information for all patients who receive FazaClo™ Orally Disintegrating Tablets.

PRESCRIBING INFORMATION

Please see full Prescribing Information, including BOXED WARNINGS regarding agranulocytosis, seizures, myocarditis, and other adverse cardiovascular and respiratory effects. Do not open tablet blister until immediately prior to use. Phenylketonurics: FazaClo Orally Disintegrating Tablets contain phenylalanine. FazaClo(TM) (clozapine, USP) Orally Disintegrating Tablets are bioequivalent to and may be substituted for Clozaril(R)(1) (clozapine) tablets on a milligram for milligram basis(2).

(1) Clozaril(R) (clozapine) is a registered trademark of Novartis Pharmaceuticals Corporation

(2) Data on file, Alamo Pharmaceuticals


SOURCE: Alamo Pharmaceuticals

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