Italy's Newron Pharmaceuticals SpA has randomized the first patients to treatment in its first Phase IIb/III study of ralfinamide in patients with moderate neuropathic low back pain.
The SERENA study will evaluate the safety and efficacy of two dose regimens of ralfinamide compared to placebo. It could be one of the two pivotal studies required for an approval in NLBP, an indication with a prevalence of about 8% of the population with no approved treatments currently available.
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