A phase IIb / III study of ralfinamide in patients with at least moderate neuropathic low back pain (NLBP) conducted by Newron Pharmaceuticals has failed to yield positive results.
The 12-week study enrolled 411 patients and evaluated the safety and efficacy of the drug compared with a placebo.
The results did not indicate any clinically significant difference between the drug and the placebo.
Newron‘s chief executive officer Luca Benatti said the results were disappointing, based on the statistically significant benefits shown in a phase II placebo-controlled trial and from preclinical studies.
“We shall be working with our external advisors to make a complete assessment of the data prior to determining our next steps, including a review of our development resource needs going forward,” Benatti said.