FDA CLEARS BRISTOL-MYERS SQUIBB'S SERZONE(R)
New Antidepressant Offers Low Incidence of Side Effects and
Markedly Different Customer-Sensitive Pricing Strategy
PRINCETON, N.J., Jan. 5 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE NYSE
See: New York Stock Exchange : BMY) announced today that the U.S. Food and Drug Administration has cleared Serzone(R) (nefazodone HCI) for the treatment of depression. The new antidepressant will be available in pharmacies within a few weeks.
"Serzone is a new option for patients and physicians, in terms of safety and tolerability in the treatment of depression," says Sheldon H. Preskorn, M.D., Director, Psychiatric Research Institute, Wichita, Kansas.
Serzone is a new antidepressant with a chemical structure unrelated to selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Serzone has two actions in the serotonin synapse. Like SSRIs, Serzone inhibits serotonin (5HT) reuptake. Unlike SSRIs, Serzone blocks 5HT2 receptors. Preclinical studies also show inhibition of norepinephrine reuptake and antagonism of alpha1-adrenergic receptors; no affinity for alpha2- and beta-adrenergic, 5HT1A, cholinergic cholinergic /cho·lin·er·gic/ (ko?lin-er´jik)
1. parasympathomimetic; stimulated, activated, or transmitted by choline (acetylcholine); said of the sympathetic and parasympathetic nerve fibers that liberate acetylcholine at a , dopaminergic dopaminergic /do·pa·min·er·gic/ (do?pah-men-er´jik) activated or transmitted by dopamine; pertaining to tissues or organs affected by dopamine.
adj. or benzodiazepine benzodiazepine (bĕn'zōdīăz`əpēn'), any of a class of drugs prescribed for their tranquilizing, antianxiety, sedative, and muscle-relaxing effects. Benzodiazepines are also prescribed for epilepsy and alcohol withdrawal. receptors.
Clinical studies show that many depressed patients treated with Serzone experience effective antidepressant response within several weeks of the initiation of treatment. Significant improvement also was found for certain factors of the Hamilton Depression Rating Scale The Hamilton Depression Rating Scale (HAM-D) is a 21-question multiple choice questionnaire which doctors may use to rate the severity of a patient's depression. It was originally published in 1960 by Max Hamilton, and is presently one of the most commonly used scales for rating , such as the anxiety factor and the sleep disturbance factor.
Many depressed patients treated with currently available antidepressants may experience unwanted medication-induced side effects. Serzone has a low incidence of certain troublesome side effects, including tremor, agitation and sexual dysfunction. The reported incidence of sexual dysfunction, such as anorgasmia anorgasmia /an·or·gas·mia/ (an?or-gaz´me-ah) inability or failure to experience orgasm.anorgas´mic , delayed ejaculation or decreased libido with Serzone is 1.5 percent. In addition, there are no reports of anorexia, weight gain or elevated blood pressure.
Adverse events with Serzone reported with an incidence of five percent or greater and significantly different from placebo were nausea, somnolence somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess.
1. A state of drowsiness; sleepiness.
2. , dry mouth, dizziness, lightheadedness, constipation, asthenia, blurred vision, confusion and abnormal vision.
Serzone is contraindicated in patients with known hypersensitivity to nefazodone or other phenylpiperazines. Also, co-administration of terfenadine (Seldane) and astemizole (Hismanal) with Serzone is contraindicated. Co-administration with monoamine oxidase inhibitors (MAOIs) is not recommended. Since any psychoactive drug may impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Serzone therapy does not adversely affect their ability to engage in such activities.
It is recommended that Serzone therapy be initiated at 100 mg twice a day increasing to 150 mg twice a day after one week. The effective dose range is 300 mg to 600 mg per day.
As with all medicines, some patients require higher doses than others to effectively relieve their depression. To address the needs of these patients, Bristol-Myers Squibb is introducing Serzone at a single price for all dosage strengths.
Serzone will be priced 10 to 20 percent below the prevailing average wholesale prices (AWP) for selective serotonin reuptake inhibitors (SSRIs) to be responsive to the financial needs of managed care providers and physicians as well as patients. Retail pharmacy prices may vary.
According to Samuel L. Barker, Ph.D., President, U.S. Pharmaceuticals, Bristol-Myers Squibb Company, "The pricing of Serzone reflects one of the Company's principal commitments, which is to provide medications that are safe, effective and competitively priced. Providing Serzone as an effective antidepressant with a favorable safety profile at one price for all dosage strengths meets this commitment in today's changing healthcare environment. Now, a sensibly priced antidepressant is available for all depressed patients including those who may require titration of their dosage regimens. Because of its promising clinical profile and patient-responsive pricing plan, we expect Serzone to be a significant step forward in the treatment of depression."
Clinical depression is a serious medical illness that affects 14 million adult Americans each year. The U.S. market for antidepressants is estimated to be nearly $2.9 billion in 1995. It is projected that the entire market for antidepressants will more than double to $6 billion by 1998.
Bristol-Myers Squibb is a diversified, research-based health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. The Company is among the world's leading makers of cardiovascular, anticancer, anti-infective, central nervous system and dermatological therapies and non-prescription medicines.
/EDITORS' ADVISORY: To obtain a copy of the product label via fax, please call toll-free 1-800-753-0352, extension 702./
/CONTACT: Patrick D. Donohue, 609-252-5685, or Robert F. Laverty, 609-252-5551, both of Bristol-Myers Squibb Company/
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