If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Remeron Cleared by FDA for the Treatment of Depression WEST ORANGE, N.J., June 19, 1996 -- Organon, Inc. today announced that the U.S. Food and Drug Administration (FDA) cleared for marketing Remeron(TM) (Mirtazapine) Tablets for the treatment of depression. Remeron is the first agent in a new class of anti-depressants. Remeron stimulates norepinephrine and serotonin release while also blocking two specific serotonin receptors, (5-HT2 and 5-HT3). Remeron's ability to target specific serotonin receptors marks the next significant advance in the evolution of bio-chemical selectivity in the brain to treat depression. "Remeron represents the biggest advance in receptor selectivity since Selective Serotonin Reuptake Inhibitors (SSRI's) were introduced in the early 1980's. Remeron's ability to specifically target serotonin receptors is critical, since it minimizes common side-effects patients typically find undesirable with most other agents, such as decreased sexual drive, nervousness and insomnia," said Dr. Paul Lammers, Medical Director at Organon, Inc. CLINICAL TRIAL DATA The FDA clearance of Remeron is based on efficacy data from clinical trials involving approximately 3,000 people. Results from placebo and amitriptyline-controlled clinical trials supported the conclusion that Remeron provides effective relief of depression. SIDE EFFECT PROFILE Side effects observed in clinical trials were mostly mild and generally have not caused patients to stop taking Remeron. The commonly reported drug-related side effects in patients taking Remeron were somnolence, increased appetite, weight gain and dizziness. DEPRESSION Depression is the most documented and common of all psychiatric disorders, dating back to ancient times, when clinical definitions were non-existent and depression was referred to as "melancholia." Clinical depression occurs in persons of all ages, ethnic groups and socio-economic groups, but because of the stigma often associated with depression, it is one of the least diagnosed diseases in the world. In individuals with clinical depression, data has shown low levels of serotonin vs. other receptors, to be the primary factor leading to low self-esteem, fatigue and suicidal tendencies as well as other psychologically debilitating consequences. "Today the FDA has cleared a significant addition to the current arsenal of anti-depressants. Remeron takes the critical ability of serotonin receptor specificity to a new level which is so important in mitigating side-effects that current anti-depressants cause, said Dr. Paul Lammers, Medical Director at Organon, Inc. ORGANON Founded in 1923, Organon develops and markets ethical pharmaceutical products in the areas of contraception, hormone replacement therapy, infertility, psychiatry, hematology, oncology and anesthesiology. Organon currently markets the oral contraceptive, Desogen(R); the USA's most widely used surgical muscle relaxants, Zemuron(TM) and Norcuron(R), and is the only one of two companies marketing a human menopausal gonadatopin (hMG) infertility drug, Humegon(TM).
|
