Posted by ben on July 7, 2005, at 8:19:53
Double-blind, placebo-controIled, multicenter study evaluating nemifitide, a now pentapeptide antidepressant, when given daily or every other day for three weeks in the treatment of major depressive disorder
J.P. Feighner, L. Sverdlov*, I Hlavka, G. Nicolau,
G. Tonelli, J. Freed. Innapharma, Inc., Park Ridge, NJ,
USA
Purpose: In previous Phase II clinical trials with nemifitide, significant antidepressant effect has been noted when giving 5-10 subcutaneous doses over one to three weeks. Recent preclinical experience with the Flinders Sensitive Line Rat Model (Dr. David Overstreet) demonstrates that every other day dosing is as good as daily dosing in predicting robust behavioral changes, consistent with antidepressants in this model This new proof of principle study is designed to evaluate the efficacy of nemifitide given either daily or every other day versus placebo over a three-week treatment period in subjects diagnosed with major depressive disorder.Method: Ninety-five subjects, at six different centers (principal investigators: Drs. John Carman, Daniel Grosz, Murray Rosenthal, Raj Rajani, Ward Smith, and Michael Liebowitz) were randomized to one of three treatment groups. All subjects received 15 subcutaneous doses Monday through Friday over three weeks with 160 mg of nemifitide (group 1), or placebo (group 2), or 160 mg of nemifitide every other day on Monday, Wednesday and Friday with placebo doses on Tuesday and Thursday for a total of nine active doses and six placebo doses (group 3). The follow up period after the end of treatment was three weeks for assessment of clinical response. The main inclusion criteria were diagnosis of major depressive disorder according to DSM-IV, baseline MADRS >25 and CGI (severity of illness) >4 at screening and at baseline (pre-dose). The exclusion criteria were standard for a clinical trial for major depression. The primary efficacy variable was MADRS (change from baseline). The secondary efficacy variables were HAMD-17 17, Carroll Self-Rating Depression Scale and CGI. The safety profile was based on adverse events, concomitant medication, vital signs, physical exams, ECG, and clinical laboratory evaluations.
Results: The study demonstrated the statistical superiority of the 160 mg dose given every other day over placebo on multiple ratings scales at multiple time points throughout the study. The 160 mg dose of nemifitide given daily Monday through Friday for three weeks was not significant in separating from placebo. Safety results provided no evidence of significant adverse events associated with the administration of nemifitide and the side effects from nemifitide were comparable to those from placebo, There were no dropouts because of significant side effects.
Conclusions: Data from this new proof of principle clinical trial provides confirmation that nemifitide has the potential to be a safe and effective antidepressant drug. The results from this study support every other day dosing of 160 mg of nemifitide over three consecutive weeks to be an effective regimen.
I think these are good news but in which phase of development is nemefitide now ? Phase II or phase III ? Nemefitide could be a superior antidepressant, but what is about pricing and application (subcutaneous is probably expensive). And we should think on other drugs with potential to be superior antidepressant like saredutant from Sanofi-Aventis. Probably saredutant will be in pharmacys in lat 2007 or early 2008. Nemefitide looks like to reach the market 2-3 years later. That could be too late, if sareduntant is as good as nemifitide and probably cheaper !Whats your opinion ?
Ben
poster:ben
thread:524529
URL: http://www.dr-bob.org/babble/20050702/msgs/524529.html