Dolorac Nasal Solution: Phase II data

Top-line data from a double-blind Phase II trial in 92 evaluable patients with >=180 headache days per year showed that twice-daily Dolorac for either 14 or 28 days missed the primary endpoint of significantly reducing headache frequency vs. vehicle (44% vs. 41% reductions, p=0.3338). The endpoint was measured from treatment period 1, in which patients received single-blinded twice-daily vehicle for 28 days, to treatment period 2, in which patients received twice-daily Dolorac or vehicle for 14 or 28 days. However, twice-daily Dolorac for 28 days did significantly reduce headache frequency by 30% between treatment periods (p=0.0031), whereas vehicle non-significantly reduced frequency by 18% (p=0.2829). ...