PRDX
Looking for a place to invest my ill-gotten BCRX gain...
Any sense on when this phase III will complete and how many phase III trials will be required (they say at least two, I suspect more)? Any sense on what kind of data package will be required for submission?
I reviewed the labels for several approved agents for GAD. The venlafaxine (Effexor) label has a total of four studies in GAD, including two 6-week studies and two 24-week studies. I have no idea which data they used for approval.
Although cross-agent comparisons are difficult, it doesn't look like this is any more efficacious than other agents out there for GAD. It might be better tolerated, but speaking from experience APRs are a big deal for the FDA.
Also, what makes them think that this agent is deserving of a SPA?
Thanks,
John
Phase III Study Design
The Phase III trial is an eight-week, double-blind, placebo-controlled, multi-center study. The trial includes approximately 20 sites in the United States and is expected to enroll up to 310 patients with moderate-to-severe GAD who will be randomized into one of two arms, consisting of approximately 155 patients each: a placebo arm, or a PRX-00023 treatment arm, in which patients receive a dose of 40 mg administered over a three-day period followed by an 80 mg once daily for the remainder of the study. The primary objectives in this trial are to evaluate the efficacy of PRX-00023 in GAD as measured by the change from baseline in the HAM-A scale, and to assess the safety and tolerability of PRX-00023 during treatment of patients with GAD. The HAM-A scale is the only FDA accepted standard for the evaluation of anti-anxiety activity, and it is used in all pivotal trials of drug candidates for the treatment of GAD. This trial will be the first of at least two pivotal trials with PRX-00023 for the treatment of GAD.
