Prurisol competition....can anyone tell from the description below (Pfizer) whether this has the potential to impact Prurisol?
Co reports top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials Program, OPT Pivotal #1 and OPT Pivotal #2, evaluating the efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis.
The OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib, as a 5 mg or a 10 mg dose taken as a pill twice-daily, met the primary efficacy endpoints of statistically significant superiority over placebo at Week 16 in the proportion of subjects achieving a Physician's Global Assessment response of "clear" or "almost clear," and the proportion of subjects achieving at least a 75% reduction in Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis.
No new safety signals for tofacitinib were observed in the OPT Pivotal #1 or OPT Pivotal #2 studies. Detailed analyses of these studies, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting.
Top-line results from the first two studies from the OPT Program, OPT Compare and OPT Retreatment, were previously announced in October 2013, and these four studies, in addition to a long-term extension study, will form the planned psoriasis submission package to regulatory authorities in various markets.
Pfizer currently intends to submit a supplemental New Drug Application to the FDA for the approval of tofacitinib 5 mg and 10 mg twice-daily for the treatment of adults with moderate-to-severe chronic plaque psoriasis by early 2015.
