FDA gives green signal to Vandas' schizophrenia drug

Vanda (VNDA) stocks soar

Following the news, shares of the company jumped up to $8.00 from their Wednesday closing price of $1.08 on Nasdaq.

The Director of the FDA's division of psychiatry products, Dr. Thomas Laughren, said, “Schizophrenia can be a devastating illness requiring lifelong treatment and therapy."

"Medications for schizophrenia can ease many symptoms, allowing people to live more independent lives," he added.

According to the FDA, the schizophrenia drug will carry a black box label (the FDA´s strongest warning), just like other atypical antipsychotic class of drugs. The warning alerts users to a heightened risk of death linked with off-label use of these drugs to treat behavioral problems in elderly people with dementia related psychosis.

Approval from FDA

The FDA in July 28, 2008 delayed the initial application for the Iloperidone by asking for more information. The Rockville, Maryland-based company proved with data that the drug is a safer alternative for treating patients with severe mental disorders. However, the FDA connected the other tablets with some side effects, such as weight gain and diabetes.

The FDA gave green signal to Iloperidone only after the Rockville, Maryland-based company provided the results of the four-week trial and three-year long trials. The study conducted for a period of four weeks found that iloperidone slashed the symptoms of schizophrenia more than a placebo and about the same result as seen with Geodon (Pfizer Inc.).

The drug, iloperidone is a mixed dopamine D2/serotonin 5HT2A receptor antagonist, which belongs to the class of atypical anti-psychotics. The efficacy and safety of Fanapt were studied in clinical trials with over 3,000 patients, according to the company statement released May 6, 2009.

Schizophrenia

Nearly 1 percent of the adult population in between the ages 18 and above in the United States is affected by, schizophrenia, the complex brain disorder.

Some of the prominent symptoms of the disorder are hallucinations (hearing voices that are not there), delusions, thought disorders, social withdrawal, inappropriate responses and impaired thinking and memory.

These symptoms can make patients with the disorder afraid and withdrawn. Antipsychotic drugs help in stabilizing some of the symptoms.