Posted by jrbecker on October 25, 2005, at 18:14:26
In reply to Re: FDA panel votes against need for longterm trials, posted by SLS on October 25, 2005, at 17:59:02
another related article....
Antidepressant Long-Term Studies Prior To Approval Should Not Be Required, Cmte. SaysLong-term efficacy studies for antidepressants should not be required to be completed prior to approval, FDA's Psychopharmacologic Drugs Advisory Committee said Oct. 25.
"I don't see the added value....I see mostly disadvantages," Committee Chair Wayne Goodman (University of Florida McKnight Brain Institute) said.
The committee unanimously voted against an FDA proposal for sponsors to accumulate data for both acute and longer-term efficacy trials at the time of filing of an application for major depressive disorder drugs.
Goodman said that more long-term efficacy data are needed for antidepressants, but added: "I just don't think this is the right approach."
Drug manufacturers presenting at the committee meeting argued that a requirement for long-term studies prior to approval would delay marketing and hinder development of antidepressants.
Lilly Exec Director-Neuroscience Medical Research David Michelson maintained that the "potential for delay is really considerable...more than a year in some cases."
FDA Division of Psychiatric Products Director Thomas Laughren pointed out that both acute and long-term efficacy are required by the European Medicines Agency for antidepressant drugs.
While the EMEA requirement for long-term data may delay antidepressant marketing in Europe, manufacturers noted that the primary market for psychiatric drugs is in the U.S. and therefore a similar requirement by FDA would be more deleterious to both the companies and patients.
Laughren acknowledged that most antidepressant drug manufacturers eventually conduct long-term studies but that it may take three to four years post-approval to complete them. FDA does not have regulatory mechanisms to ensure that they are completed in a timely manner, he added.
Committee members emphasized that long-term studies should be conducted as quickly as possible. Some committee members proposed that the studies be started prior to approval of the drug, or at least that the trial design be set by the company and FDA.
A number of committee members said that more long-term safety data on antidepressants in adults and children is an even greater need than efficacy data.
Since the committee answered negatively to the first FDA question, the members did not discuss long-term trial design. FDA had proposed a six-month run-in period of response prior to randomization into a withdrawal study for relapse prevention.
Laughren noted that one of the reasons FDA brought the question to the committee is because of the relatively high failure rate of trials for short-term acute treatment with antidepressants. However, the success rate of the relapse prevention trials that have been conducted, he noted, have been "very high."
Another impetus for the meeting may have been questions about antidepressant efficacy in light of safety findings regarding the occurrence of suicidality in children and possibly adults.
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Posted: Tuesday, October 25, 2005
poster:jrbecker
thread:571790
URL: http://www.dr-bob.org/babble/20051024/msgs/571817.html