- Treatment with the NaV1.8 inhibitor VX-548 met the primary endpoint in both Phase 2 proof-of-concept acute pain studies following abdominoplasty or bunionectomy surgery -
- VX-548 was generally well tolerated -
- Results further highlight NaV1.8 as a new mechanism that could create an alternative to opioids for the treatment of pain -
- Company plans to advance VX-548 into pivotal development in acute pain in H2 2022 following discussions with regulators –
BOSTON--(BUSINESS WIRE)--Mar. 31, 2022-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from two Phase 2 proof-of-concept (POC) studies that investigated treatment with the selective NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty surgery or bunionectomy surgery. Treatment with an initial dose of 100 mg followed by 50 mg every 12 hours of VX-548 (high-dose) compared to placebo resulted in a rapid, statistically significant and clinically meaningful improvement in the primary endpoint of the time-weighted Sum of Pain Intensity Difference over 48 hours (SPID48), which was consistent in both trials. The study also included an active reference arm of the opioid hydrocodone bitartrate/acetaminophen (HB/APAP) to support the evaluation of the VX-548 treatment effect.
VX-548 was generally well tolerated in both studies. Most adverse events (AEs) were mild to moderate and there were no serious adverse events (SAEs) related to VX-548. Fewer patients discontinued treatment in the mid- and high-dose VX-548 arms than in the placebo group or HB/APAP reference arm.
Based on these positive proof-of-concept efficacy results, and the safety and tolerability profile across both the abdominoplasty and bunionectomy studies, Vertex plans to advance VX-548 into pivotal development in the second half of 2022, following discussions with regulators.
VX-548 Results in Patients Undergoing Bunionectomy
Efficacy Results
The bunionectomy study met its primary endpoint, showing a statistically significant improvement in SPID48, as recorded on a Numeric Pain Rating Scale (NPRS), for those treated with VX-548 at the high dose compared to placebo. Higher SPID48 values represent greater improvements in pain relief. The onset of action was rapid and was sustained through the duration of assessment.
Primary Efficacy Outcomes:
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https://news.vrtx.com/press-release/vertex-announces-statistically-significant-and-clinically-meaningful-results-two |
