The randomized, placebo-controlled, double-blind study is designed to prove the concept of the use of EMA401 in PHN patients and to demonstrate its pharmacokinetic profile, tolerability, and safety.
The primary endpoint of the trial is reduction in mean daily pain score versus placebo over the last week of 28 days of treatment.
Secondary endpoints include a number of further measures of pain and quality of life.
Spinifex Pharmaceuticals CEO Tom McCarthy said this is the first of three Phase 2 trials to be initiated and they look forward to confirm the promise for EMA401 they have seen in their earlier clinical and pre-clinical studies.
The company intends to enroll approximately 170 patients in total.
The company said that in addition to treat PHN, EMA401 is also being developed to treat neuropathic pain indications including pain and hypersensitivity in peripheral nerve injury patients, and pain and hypersensitivity in cancer chemotherapy patients.