The Phase III programme will have two double-blind, randomised, placebo-controlled trials to assess the safety and efficacy of VX-548 for moderate to severe acute pain treatment after bunionectomy or abdominoplasty surgery.
These trials will also have a hydrocodone bitartrate/acetaminophen treatment arm.
The time-weighted Sum of the Pain Intensity Difference over the first 48 hours of treatment (SPID48), as analysed on the 11-point Numeric Pain Rating Scale (NPRS) versus placebo will be the primary endpoint of the trials.
The SPID48 of VX-548 versus hydrocodone bitartrate/acetaminophen will be the key secondary endpoint of both trials.
Furthermore, a third, single-arm trial will assess the safety of VX-548 across various other moderate to severe acute pain types for up to 14 days.
An oral, selective inhibitor of NaV1.8, VX-548 is the latest molecule from the NaV1.8 inhibitor portfolio of the company to enter clinical trials.
The latest development comes after the company reported positive data from Phase II trials earlier this year and entered an agreement on the design of the pivotal development programme with the US Food and Drug Administration (FDA).
Vertex Pharmaceuticals Global Medicines Development and Medical Affairs executive vice-president and chief medical officer Carmen Bozic said: “We are very pleased to complete our discussions with the FDA and reach agreement on the design of the pivotal development programme for acute pain.
“VX-548 has demonstrated a positive benefit-risk profile in Phase II and we are working with urgency to bring forward a medicine that delivers effective pain control without the addictive potential to patients who are waiting.”
In addition, the company plans to commence a double-blind, active-controlled, randomised, dose-ranging Phase II trial of VX-548 in neuropathic pain by this year-end.
It will assess the safety and efficacy of VX-548 in painful diabetic peripheral neuropathy patients.
In July 2021, the company announced plans to begin a Phase III development programme of the once-daily experimental combination of VX-121, tezacaftor and VX-561 (deutivacaftor) for cystic fibrosis.