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May 14, 2003
Marietta, Ga. (May 12, 2003) - Responding to the need for individualized treatment and flexible management of benzodiazepine therapy, Solvay Pharmaceuticals, Inc. announced today that it is introducing KLONOPIN® WAFERS (clonazepam orally disintegrating tablets), a new quick-dissolve formulation of KLONOPIN® Tablets.
KLONOPIN® WAFERS is approved by the U.S. Food and Drug Administration (FDA) for the treatment of panic disorder with or without agoraphobia in adults. Panic disorder affects more than three million adults in the U.S. at some time in their lives.(2)
KLONOPIN® WAFERS is an orally disintegrating tablet that contains the active drug clonazepam and is designed to rapidly dissolve on the tongue, allowing patients to take the medication without water, anytime, anywhere.
“This innovative formulation, available in a blister package, offers patients the ability to take KLONOPIN® in a more convenient manner, ensuring privacy, flexibility and relief of panic attacks associated with panic disorder,” says Harold Shlevin, Ph.D., President and CEO, Solvay Pharmaceuticals, Inc.
KLONOPIN® WAFERS is available in five strengths (0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg clonazepam). The two new low dose strengths, 0.125 mg and 0.25 mg, have been added to provide physicians with the ability to more precisely manage dosing and titration of clonazepam. This is especially important when titrating doses upward to achieve symptom control, and also when moving to discontinue treatment, which must be done gradually so patients do not experience withdrawal symptoms.
“Given its 30-year heritage of safe and effective use, KLONOPIN® has been the benzodiazepine of choice in the psychiatric armamentarium for decades. The addition of the new quick-dissolve formulation provides physicians with more options when prescribing KLONOPIN® WAFERS alone and/or in combination with an antidepressant – a common practice in psychiatry and primary care,” says Jonathan Davidson, M.D., Professor of Psychiatry and Director of the Anxiety and Traumatic Stress program at Duke University Medical Center in Durham, North Carolina.
Benzodiazepines are increasingly being used in conjunction with selective serotonin reuptake inhibitors (SSRIs) to offer immediate relief during the four to six weeks that SSRIs take to become effective.(3)
According to Jerilyn Ross, M.A., L.I.C.S.W., President and CEO, Anxiety Disorders Association of America (ADAA), “Treatment solutions that offer patients new options and greater flexibility are most welcome by those suffering from panic disorder.”
Panic Disorder
Panic disorder is an anxiety disorder characterized by recurrent unexpected panic attacks followed by at least one month of persistent concern about having another attack. Many people with panic disorder develop intense anxiety between episodes, in anticipation of the next attack, and they may develop phobias about places or situations where panic attacks have occurred. This may eventually develop into agoraphobia, an inability to go beyond known and safe surroundings because of intense fear and anxiety. Women are twice as likely as men to develop panic disorder.(4)
The most commonly observed adverse events associated with KLONOPIN® in clinical trials were drowsiness, depression, and problems with coordination and balance (ataxia).
As with any benzodiazepine, physicians should caution patients about driving, operating machinery and the simultaneous ingestion of alcohol and other CNS depressant drugs.
Patients should be advised to consult their physician before increasing, decreasing or discontinuing the dose of KLONOPIN® WAFERS; or if they become pregnant or intend to become pregnant during therapy
Withdrawal symptoms, including convulsions, psychosis and hallucination have occurred following abrupt discontinuation of clonazepam. Individuals at risk for addiction should be under careful surveillance when receiving KLONOPIN® WAFERS.(5)
KLONOPIN® WAFERS received FDA approval in 1997 through submission by Hoffmann-La Roche Inc. Now, through a strategic alliance between Solvay Pharmaceuticals, Inc. and Roche, the product will be marketed by Solvay Pharmaceuticals and distributed by Roche.
"KLONOPIN® has been a pioneer in the benzodiazepine category since its approval in 1975," said Richard Hinson, Vice President of Commercial Operations Primary Care at Roche. "With the introduction of KLONOPIN® WAFERS, a new formulation of KLONOPIN®, we chose to work with Solvay Pharmaceuticals, a highly respected company with strong sales and marketing capabilities in the psychiatric arena. Roche continues to build upon its rich history in this therapeutic area."
Solvay Pharmaceuticals, Inc. of Marietta, Georgia, is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay S.A. chemical and pharmaceutical group, headquartered in Brussels, Belgium.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufacturers and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C. For more information on the Roche Pharmaceuticals business in the United States, visit the company's web site at: http://www.rocheusa.com.
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1 “Benzodiazepine Market” National Prescription Audit (NPA), IMS Health, 2003.
2 Understanding panic disorder. NIH publication No. 95-3509, Revised 1995, National Institute of Mental Health, Bethesda, MD.
3 Goddard AW, et al. Early co administration of clonazepam with sertraline for Panic Disorder. Arch Gen Psychiatry. 2001;58:681-686.
4 Robins LN, Regier DA, eds. "Psychiatric disorder in America: the Epidemiologic Catchment Area Study." New York: The Free Press. 1991.
5 KLONOPIN® WAFERS Package Insert.
Please see important KLONOPIN® WAFERS safety and prescribing information at www.solvaypharmaceuticals-us.com.
*KLONOPIN is a registered trademark of Hoffmann-La Roche Inc.
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