Vixotrigine for Small Fiber Neuropathy Provides Positive Impression of Change for Patients

In a phase 2 CONVEY study (NCT03339336), treatment with the nonopioid, investigational oral pain medication vixotrigine (Biogen; Cambridge, MA) resulted in statistically significant improvement compared with placebo for people with small fiber neuropathy (SFN). Improvement was measured with the Patient Global Impression of Pain (PGIC). 

Other results from this placebo-controlled, randomized, double-blind withdrawal study include improvement in the mean average daily pain score vs placebo at week 12 with 200mg vixotrine twice daily (P=.050). The mean worst daily pain score at week 12 also improved at this dose vs placebo (P=.046). However, these effects on daily pain scores were not seen at the higher dose of 350 mg twice-daily vs placebo. Subgroup analysis showed that pain reduction occurred primarily in those with SFN due to diabetes mellitus rather than participants with idiopathic SFN. 

“We are encouraged by the overall results of the CONVEY study, especially given the significant unmet medical need for additional agents to treat chronic painful neuropathy,” said Katherine Dawson, MD, senior vice president and head, Therapeutics Development Unit, Biogen. 

Both doses of vixotrigine were generally well-tolerated and the safety profile was consistent with previous studies of vixotrigine with no evidence of abuse potential. In the open-label period, common adverse events (AEs) (incidence ≥ 2.5%) were dizziness, headache, vertigo, and nausea. Across the entire study, the majority of AEs were mild or moderate in severity. 

Vixotrigine is an investigational, peripherally and centrally acting, voltage- and use-dependent voltage-gated sodium channel blocker.