Fanapt Schizophrenia Drug Gets FDA Approval

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Main Category: Schizophrenia
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 07 May 2009 - 1:00 PDT

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The US Food and Drug Administration (FDA) has approved Fanapt tablets (iloperidone) made by Patheon Inc of Mississauga, Ontario, for Vanda Pharmaceuticals Inc of Rockville, Maryland, for the treatment of adults with schizophrenia, said an announcement on the FDA website on Wednesday.

The news that Vanda has won US approval for its first product sent shares in the company soaring in extended Nasdaq Stock Market trading yesterday, said the Washington Post.

This is a complete reversal of the situation last summer when the company's market value fell by three quarters in one day after the FDA delayed the initial application and asked the company to provide more evidence.

Dr Thomas Laughren, director of the FDA's Center for Drug Evaluation and Research (CDER) Division of Psychiatry Products told the press that:

"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.

Fanapt belongs to a class of drugs knows as atypical antipsychotics, all of which are accompanied by the FDA's strongest warning: the so-called boxed warning.

The warning alerts doctors to the increased risk of death that occurs when the drug is given to treat behavioral problems in older people with dementia-related psychosis. The FDA has not approved Fanapt for patients with dementia-related psychosis, but doctors are allowed to prescribe FDA approved drugs for "off label" use.

The FDA approved Fanapt on the evidence of two placebo-controlled short duration trials where the drug outperformed the placebo in reducing symptoms of schizophrenia.

The most common unwanted side effects reported during the trials included weight increase, dizziness, fatigue, drowsiness, nasal congestion, dry mouth, sudden fall in blood pressure causing light-headedness upon standing (orthostatic hypotension) and rapid heart rate (tachycardia).

In any given year, about 1 in 100 adult Americans has schizophrenia, a chronic, severe and disabling brain disorder, the most obvious symptoms of which include delusions, hallucinations, abnormal expressions of emotion and disordered thinking and behaviour. The most common hallucination is hearing voices that other people don't hear, which can make a person with schizophrenia fearful and withdrawn.

The Washington Post reports that the market for atypical antipsychotics amounts to nearly 16 billion dollars.

Main sources: FDA, Washington Post.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today