Personal Injury Law

FDA Backs New Seroquel Formula For Bipolar Disorder

By Jane Akre

Seroquel, typically used to treat schizophrenia, has received FDA approval for its extended-release version to be used to treat bipolar disorder. 

That means Seroquel XR ("XR" indicates extended release), is the first medication cleared for depressive and manic episodes associated with bipolar disorder.  It is approved as a once-daily treatment. The previous version was taken twice a day and not approved for mixed episodes.

The drug generated $4 billion in sales for drug maker AstraZeneca (AZN) in 2007. 

Recreating the drug with an XR means that the patent is protected on this new version until 2017.  The original formula was set to expire in 2011. Patients will be switched into the XR version. 

Some investors believe the large-cap pharmaceuticals offer a good buying opportunity.

Seroquel (Quetiapine Fumarate) was approved by the FDA in 1997.  

Earlier this year, Bloomberg reported that teenagers and the elderly were increasingly being given a class of anti-psychotic drugs not cleared by regulators, among them Seroquel and Zyprexa which had driven growth for both pharmaceutical companies.  In adolescents, the medications are given for depression, autism and hyperactivity, and in the elderly for dementia and insomnia. 

Half of Seroquel's sales in 2006 were reportedly for off label use.   

In September 2003, the FDA recommended that six atypical antipsychotics, including Seroquel, carry a diabetes warning because of a study that linked three of the six medications to the disorder. According to the study, Seroquel patients were three times more likely to develop diabetes than those taking older drugs.

The most common side effects of Seroquel use include, but may not be limited to, drowsiness, weight gain, restlessness, dizziness, increased appetite, constipation and fatigue.

Antipsychotic drugs such as Seroquel have been linked to two serious complications known as Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia.

NMS is a potentially fatal syndrome involving muscle rigidity, an altered mental state and symptoms of cardiac instability (irregular blood pressure, tachycardia, irregular pulse).

Tardive Dyskinesia is a central nervous system disorder characterized by involuntary movements of the limbs as well as twitching of the face and tongue.  #

Full post as published by InjuryBoard on October 10, 2008 (boomark / email).