AstraZeneca's schizophrenia drug gets the nod in the Netherlands

Seroquel XR (quetiapine fumerate), a once-daily treatment for schizophrenia, allows patients can achieve a dose within the recommended range as early as the second day of treatment.

The Netherlands regulatory authority Medicines Evaluation Board (MEB) approval also included relapse prevention in the long term treatment of schizophrenia.

The extended-release formulation was developed with the aim of improving dosing and titration options for patients and their doctors as they face the challenge of achieving successful treatment of schizophrenia.

Clinical data for the formulation was presented at the European Congress of Psychiatry (ECP) in Madrid in March where University Medical Centre, Utrecht, Professor and Chair of the Department of Psychiatry and Head of the Division of Neuroscience Rene Kahn said: "In these studies Seroquel sustained release formulation showed its potential as a once-daily treatment for both acute and clinically stable schizophrenia.

"Statistical significance on the primary endpoint was seen at doses between 400 and 800 mg/day and patients achieved that range within two days of starting treatment - that is an advantage over original formulation quetiapine, where the initial dose escalation is not so simple.

In mental healthcare, striving for treatment that is simpler and more practical is an important objective for patients and doctors."

Schizophrenia is a severe mental disorder, characterised by profound disruptions in thinking, affecting language, perception, and the sense of self and affects an estimated 24 million people worldwide, according to World Health Organisation statistics.

The active pharmaceutical ingredient in Seroquel is quetiapine, a second generation anti-psychotic, known as an atypical anti-psychotic, and belongs to the dibenzothiazepine derivatives chemical class.

The drug works by targeting the specific areas of the brain (pre-frontal cortex, striatum, limbic system and anterior pituitary) that are affected by the illness and helps to regulate the actions of the neurotransmitters - dopamine and serotonin - that play an important role in brain functioning.

The original Seroquel (quetiapine), a twice-daily immediate-release formulation, was launched in 1997, with global sales last year reaching $3.4bn (€2.5bn).

Seroquel has since been approved as a treatment for mania associated with bipolar disorder and for bipolar depression.

The Seroquel patent expires in the US and Europe in 2011 and 2012 respectively.

AstraZeneca is undergoing other clinical studies of Seroquel XR covering its use in bipolar disorder, major depressive disorder and generalised anxiety disorder.

The approval in the Netherlands will now see AstraZeneca proceeding with a Mutual Recognition Procedure, seeking similar approvals across Europe.

Seroquel XR was approved in the US in May.

AstraZeneca was unavailable for comment.