Pharmaceutical Business review

Spinifex EMA401 meets primary endpoint in Phase 2 trial

The placebo-controlled randomised study met the primary endpoint by reducing mean daily pain score versus placebo over the last week of 28 days of treatment.

According to study results, a statistically significant and clinically meaningful reduction in mean pain intensity from baseline to week four for subjects on active treatment when compared to placebo was observed.

The study also met secondary endpoint by demonstrating a significantly greater proportion of patients on active treatment reported a more than 30% reduction in mean pain intensity score compared to baseline.

Spinifex Pharmaceuticals CEO Tom McCarthy said, "We look forward to advancing EMA401 further in PHN and other neuropathic pain indications including cancer chemotherapy induced neuropathic pain and painful diabetic neuropathy.

No serious treatment related adverse events were observed and EMA401 was generally safe and well tolerated in the study.