Seroquel XR's FDA approval does not change Decision Resources' earlier antipsychotics market forecast

Jan 28 2010

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the recent decision by the U.S. Food and Drug Administration (FDA) to grant approval of AstraZeneca's Seroquel XR for adjunctive treatment of major depressive disorder will not change Decision Resources' market forecast for the indication. As previously forecasted, Seroquel and Seroquel XR will garner nearly one quarter of antipsychotics sales as adjunctive treatments for major depressive disorder in 2013 in the world's major pharmaceutical markets.

The Pharmacor finding from the topic entitled Major Depressive Disorder shows that, although the FDA approved Seroquel XR as an adjunctive therapy, AstraZeneca will need to further demonstrate the safety and clinical benefits of Seroquel XR in order for the drug to gain approval as a monotherapy for the indication.

"After reviewing Seroquel XR's safety and efficacy data, the FDA's Psychopharmacologic Drugs Advisory Committee concluded that the drug was effective as both a monotherapy and an adjunctive therapy but was not acceptably safe as a monotherapy for broad treatment of major depressive disorder," said Decision Resources Analyst Alana Simorellis, Ph.D. "The committee further recommended that the agent be used as supplemental treatment for patients with depression who do not achieve symptom relief from currently approved therapies."

The Pharmacor findings also reveal that, despite positive Phase II clinical trial results for Targacept's nicotinic acetylcholine receptor (nAChR) antagonist TC-5214, the safety and efficacy of drugs in this class has yet to be established in Phase III clinical trials. The market entrance of nAChR modulators has, to date, been prevented by their safety and tolerability profiles that include the risk of motor, cardiovascular and gastrointestinal side effects.