AstraZeneca files first for European bipolar disorder
pharmafile | October 24, 2003 | News story | |Â Â Â
AstraZeneca have filed the first European marketing application for an atypical antipsychotic as a treatment for manic episodes related to bipolar disorder.
The submission of Seroquel via the mutual recognition procedure comes just over a month after the company filed a similar application in the US and marks the latest in several antipsychotics seeking such an indication and the first in Europe.
The newer atypical antipsychotics represent the most promising treatment for bipolar disorder, also known as manic-depression, for which there is a significant unmet need. Current therapies, such as lithium, valproate and older antipsychotics, have limited efficacy and/or unmanageable side-effects which undermine patient compliance.
Johnson & Johnson's Risperdal was submitted to the FDA in December for adjunctive and monotherapy treatment of manic episodes, while Eli Lilly has filed for US approval for a combination of Zyprexa and antidepressant Prozac for the condition.
Zyprexa the top selling antipsychotic with 2001 sales of $3.1 billion is already indicated for short-term management of manic episodes, with trial results published in September showed it was superior to lithium in preventing patients relapsing into mania over the long-term.
GlaxoSmithKline is also seeking to enter the bipolar disorder market, with its ageing anti-epileptic Lamictal. However, the drug has been filed in the US for the long-term management of depressive, rather than manic, episodes.
Adam Wickes, Psychiatry Analyst at Datamonitor, said because of the long-term cyclical nature of the condition, the cost of running clinical trials for bipolar disorder has been a major hurdle to obtain an indication.
"Traditionally, the route to obtain a bipolar disorder indication has been to first gain an indication in schizophrenia, and then use the drug's revenues to fund the bipolar disorder trials", he said.
He added that off-label use of the atypical antipsychotics to treat bipolar mania has been extensive, with doctors looking at a drug's ability to treat schizophrenia when deciding which atypical to prescribe.
Studies of Seroquel (quetiapine) have found it to be significantly more effective in treating manic episodes in conjunction with mood stabilisers compared to mood stabilisers alone, and has shown to be well tolerated. Use as a monotherapy has also proven successful.
Recent studies published in the Journal of Clinical Psychiatry have placed the incidence of bipolar disorder at up to 4% of the adult population in the US three times the rate previously thought. Around a third of patients are misdiagnosed as having major depression and between a fifth and a quarter attempt suicide.
