Tuesday, Vertex Pharmaceuticals Incorporated VRTX announced results from its Phase 3 program (two Phase 3 trials) for the selective NaV1.8 inhibitor, VX-548, for moderate-to-severe acute pain.
Treatment with VX-548 following abdominoplasty or bunionectomy surgery showed a statistically significant improvement in pain intensity difference from 0 to 48 hours (SPID48) compared to placebo and a clinically meaningful reduction in pain from baseline at 48 hours on the Numeric Pain Rating Scale (NPRS) in both studies.
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For the first key secondary endpoint, Vertex tested the hypothesis that VX-548 was superior to hydrocodone bitartrate/acetaminophen (HB/APAP) on SPID48 following abdominoplasty surgery or bunionectomy surgery.
Neither trial met this key secondary endpoint, bunionectomy: LS mean difference between VX-548 and HB/APAP = -20.2.
The second key secondary endpoint in both trials was time to meaningful pain relief compared to placebo.
VX-548 had a more rapid onset to meaningful pain relief than placebo in both the abdominoplasty and bunionectomy trials. (The median time to meaningful pain relief was 8 hours for placebo in both studies compared to 2 hours in abdominoplasty and 4 hours in bunionectomy for VX-548, respectively.)
Other secondary endpoints in both trials were generally consistent with the primary endpoint.
The Phase 3 single-arm safety and effectiveness study evaluated treatment with VX-548 for up to 14 days across a broad range of other surgical and non-surgical acute pain conditions.
The data demonstrated favorable safety, tolerability, and effectiveness at the end of treatment (83.2% of patients rated VX-548 as good, very good, or excellent in treating pain).
VX-548 was safe and well tolerated in all three Phase 3 studies. Most adverse events were mild to moderate, and no serious adverse events were related to VX-548.
Vertex plans to submit a New Drug Application to the FDA by mid-2024 to achieve a broad label in moderate-to-severe acute pain.
Price Action: VRTX shares are down 0.43% at $433.97 on the last check Tuesday.
