(RTTNews) -  Schering-Plough Corp. (SGP: News ), Thursday said its operation in Japan, Schering-Plough K.K has been granted marketing approval for Remeron or Reflex 15 mg tablets or mirtazapine indicated for the treatment of major depressive disorder.

The company indicated Remeron as a noradrenergic and serotonergic antidepressant, with a different mechanism of action compared to that of selective serotonin reuptake inhibitors or SSRI and serotonin-noradrenaline reuptake inhibitors or SNRI.

Schering-Plough developed Remeron for Japan together with the Japan-based pharmaceutical company, Meiji Seika Kabushiki Kaisha , Ltd. The product would be marketed with the trade names Remeron and Reflex.

In United States, RemeronSolTab is indicated for the treatment of major depressive disorder or MDD in adults, however, is not approved for use in pediatric patients, including children and teenagers as studies have proved antidepressants to likely increase suicidal tendency in children, adolescents, and young adults.

Short-term studies, however, have not indicated the risk of suicidality with antidepressants compared to that of placebo in adults above 24 years of age , and the risk with anti-depressants compared to placebo is also lower in adults aged 65 and older, Schering-Plough noted.
The company stated that two out of 2796 patients, who attended the premarketing clinical trials developed agranulocytosis, an acute condition involving a severe and dangerous leukopenia, while a third patient developed severe neutropenia, a hematological disorder characterized by an abnormal drop in number of a type of white blood cell called a neutrophil. However, all of the patients recovered after discontinuation of therapy.

The company said the treatment with RemeronSolTab should be discontinued, while patients develop ailments such as sore throat, fever, stomatitis or other signs of infection, along with a drop in WBC count. The patients should also be closely monitored. RemeronSolTab is also not recommended in combination with a monamine oxidase inhibitor or MAOI, or within 14 days of initiating or discontinuing therapy with an MAOI.

A six-week US controlled clinical trials indicated adverse events related to Remeron, such as somnolence, increased appetite , weight gain , and dizziness. In short-term clinical trials, 10.4% of patients discontinued therapy due to somnolence, while in a pool of pre marketing US studies 8% of patients discontinued therapy due to weight gain.

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