Leading depression drug makers such as Pfizer, GlaxoSmithKline, and Eli Lilly may face further scrutiny following the release of a new report stating that SSRI treatment increases suicidal tendencies in youths. While the report was keen to stress the positive risk/benefit ratio of the treatment, the suicidality data will no doubt cause alarm, further impacting upon the depression market.
The American College of Neuropsychopharmacology (ACNP) Task Force has concluded that data from clinical trials of selective-5-HT-reuptake-inhibitors (SSRIs) and other new generation antidepressant medications indicate a small increase in the risk of adverse event reports of suicidal thinking or suicide attempts in youths under the age of 18.
The ACNP's report states that the benefits of treating youths with depression with one antidepressant medication outweigh the increase in risk of suicidal thoughts and nonfatal suicidal behavior found in an analysis of an FDA database of adverse event reports. However, the confirmation of an increased risk in suicidality is worrying.
Regulatory agencies in the US and the UK had already raised concerns that there is an increase risk of suicide in patients aged under 18. However, the FDA has not yet recorded any suicidal deaths in adolescents, meaning the risk of increased suicidality should be considered only as a warning at present.
Still, word of a new study confirming the increased risks is likely to have an impact upon patient confidence in SSRIs. This cannot fail to worry drug companies as the depression market was worth around $16 billion in 2004, and some of the top-selling depression drugs are SSRIs.
Current SSRIs on the market include Pfizer's Zoloft (sertraline) Lilly's Prozac (fluoxetine) and Symbax (olanzapine/fluoxetine), GlaxoSmithKline's Paxil (paroxetine), and Forest & Lundbeck's Cipramil/Celexa (citalopram). Collectively, these drugs alone accounted for almost $7 billion of the total depression market in 2004.
In addition, the only drug that has presently been shown to effectively treat depression in youth, according to the ACNP report, is an SSRI (namely, fluoxetine). No other SSRI, non-SSRI new generation antidepressant or tricyclic antidepressant has demonstrated efficacy, according to the report's standards.
With SSRIs playing such an important role in the depression market, it is likely that any further statements from bodies such as the FDA or the ACNP regarding the safety or efficacy of SSRIs will have a major impact on the antidepressant market, and on those companies with a prominent stake in this sector.
Source: Datamonitor Commentwire
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