[Edaily Reporter Shin Ha-yeon ] VIVOZON PHARMACEUTICAL(082800) Affiliated company V-Vizone announced on the 6th that it had confirmed the potential analgesic efficacy of its oral, non-narcotic analgesic candidate "VVZ-2471" in a Phase 2 clinical trial, particularly in the high-dose group. (Photo courtesy of Vivazon) This Phase 2 clinical trial was conducted as a randomized, double-blind, placebo-controlled study to evaluate the exploratory analgesic efficacy and safety of VVZ-2471 in patients with postherpetic neuralgia. Participants were divided into 150 mg, 100 mg, and placebo groups and took the medication twice daily; changes in pain intensity after four weeks of treatment were evaluated as the primary endpoint.
The results showed that the high-dose (150 mg) group exhibited a consistent trend of decreasing pain intensity from Week 1 through Week 4. After 4 weeks of treatment, the proportion of patients in the high-dose group who experienced a pain reduction of 40% or more compared to baseline was 32%, more than double that of the placebo group (15%).
The company explained that these results represent an exploratory signal similar to the clinical results of pregabalin, the standard treatment for postherpetic neuralgia.
Safety and tolerability were also assessed as favorable. No serious safety issues were identified during the 4-week course of repeated dosing, and mild dizziness and nausea were reported as the main adverse reactions.
VVZ-2471 is an oral drug candidate developed based on a multi-target new drug development platform technology that previously identified the non-opioid analgesic “Anapraz.” It possesses a dual-action mechanism that simultaneously modulates the metabotropic glutamate receptor (mGluR5) and the serotonin receptor type 2A (5-HT2A).
A Vivzon official stated, “Considering that this was an exploratory clinical trial with approximately 30 participants per group, these results are meaningful,” adding, “Analysis indicates that if we secure a sufficient number of patients for a confirmatory Phase 3 clinical trial, the high-dose group is likely to achieve statistical significance.”
The official continued, “It is encouraging that the proportion of responders—those experiencing a 40% or greater reduction in pain—in the high-dose group was approximately twice that of the placebo group,” adding, “We plan to demonstrate efficacy and safety through follow-up clinical trials and expand development into the treatment of chronic neuropathic pain, including postherpetic neuralgia, as well as drug addiction.”
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