Vertex pain therapy VX-548 high dose meets main goal in 2 mid-stage studies
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Vertex Pharmaceuticals (NASDAQ:VRTX) reported results from two phase 2 studies of selective NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty or bunionectomy surgeries.
The company said 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 main goal of reducing pain intensity over 48 hours, 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 VX-548 effect.
The company noted that the results highlighted NaV1.8 as a new mechanism that could create an alternative to opioids for treating pain.
Vertex said the bunionectomy study met its primary goal of, showing a statistically significant improvement in pain severity over 48 hours for those treated with VX-548 at the high dose compared to placebo.
The abdominoplasty study also met its primary goal, showing a statistically significant improvement in pain severity over 48 hours, for those treated with VX-548 at the high dose compared to placebo.
VX-548 was generally well tolerated in both studies. Most adverse events were mild to moderate and there were no serious adverse events related to the study drug.
Vertex added that it plans to advance VX-548 into pivotal development in H2 2022, following discussions with regulators.
VRTX +2.13% to $261.99 pre-market March 31