Lyrica to challenge antidepressants with new anxiety disorder approval
Pfizer's Lyrica is to go head to head with top-selling antidepressant drugs as it enters the market to treat generalised anxiety disorder (GAD).
Lyrica (pregabalin) was first launched in 2004 for the treatment of neuropathic pain and the control of epileptic seizures, but Pfizer can now tap into the GAD market after receiving European marketing approval.
Drug treatment of GAD has been traditionally dominated by antidepressants such as fluoxetine and GSK's Seroxat, but Pfizer believes its drug offers some unique benefits over existing treatments.
The company says there are nearly 12 million patients that suffer from GAD across Europe, but estimate that only one-third of these patients are properly diagnosed, and even fewer receive effective treatment.
Lyrica's approval for GAD was based on trials of over 2,000 patients, which suggest the drug starts to work as early as the first week of use, significantly earlier than many existing treatments.
Lyrica (pregabalin) was also shown to be significantly effective in providing relief of both emotional symptoms, such as depressive symptoms and panic, as well as physical symptoms, including headaches and muscle aches.
GAD affects an estimated 5% of people at some point in their lives, and is a common and chronic psychiatric disorder characterised by excessive worry about the demands of everyday life.
Companies and clinicians working in the area are keen for GAD to be recognised as a real clinical condition, and not simply feelings of stress.
Dr. Stuart Montgomery, Professor of Psychiatry, Imperial College School of Medicine, University of London said: "GAD is much more than the normal anxiety people experience under times of stress. It is a chronic, debilitating illness that can greatly disrupt an individual's daily life, yet the disorder is under-treated.
"Now that Lyrica is available, we have a new treatment option to help alleviate a broad range of emotional and physical symptoms of this prevalent condition."
Pfizer says generalised anxiety disorder occurs more frequently in patients with other chronic medical illnesses, especially those associated with pain conditions, linking it to other Lyrica indications for neuropathic pain including peripheral neuropathic pain, diabetic and post herpetic neuropathic pain.
One of the drug's biggest rivals is Lundbeck's Cipralex, the fastest growing SSRI antidepressant in the market.
Cipralex received its EU approval to treat GAD in September after trials in more than 1,600 patients.
Not surprisingly, Lundbeck has chosen to highlight GAD's cross over with other psychiatric disorders, primarily depression, for which Cipralex is already licensed.
Lundbeck says head-to-head studies between its drug and a rival treatment, GSK's Seroxat, show Cipralex to be superior in treating the anxiety disorder.
In the UK, NICE guidance from 2004 says psychological therapy (CBT) has been proven to have the longest lasting effect on tackling the condition, followed by drug therapy (SSRIs recommended) and lastly self-help.