• Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials 
•  Treatment with VX-548 was also shown to be effective in the single arm study in a broad range of surgical and non-surgical pain conditions for up to 14 days –
• VX-548 was safe and well tolerated in all three studies –
•  Vertex plans to submit a New Drug Application to the FDA by mid-2024 

Vertex Pharmaceuticals has announced positive outcomes from the Phase 3 program evaluating VX-548 for treating moderate-to-severe acute pain, particularly following abdominoplasty or bunionectomy surgeries. The results revealed statistically significant improvements in pain intensity, as measured by the Numeric Pain Rating Scale (NPRS) and the time-weighted sum of the pain intensity difference (SPID48), compared to a placebo. VX-548 demonstrated a rapid onset of meaningful pain relief and was well-tolerated across various surgical and non-surgical acute pain conditions.

While the drug did not meet superiority over hydrocodone bitartrate/acetaminophen (HB/APAP) in certain aspects, Vertex remains optimistic about VX-548's potential as a non-opioid alternative. The safety profile of VX-548 was favorable, with the majority of adverse events being mild to moderate. Patients in the Phase 3 safety and effectiveness study reported VX-548 as effective in treating pain, further supporting its potential as a new class of acute pain medicine.

Reshma Kewalramani, CEO and President of Vertex, expressed satisfaction with the results and highlighted VX-548's ideal benefit-risk profile. With FDA Breakthrough and Fast Track designations, Vertex plans to file a New Drug Application by mid-2024, aiming to address the significant need for effective and safe alternatives to opioids in acute pain management.

Physicians, including Dr. Jessica Oswald from the University of California San Diego, underscored the importance of new treatment options for acute pain, emphasizing the potential of VX-548 to change the pain management paradigm. Vertex is also pursuing a broad label for VX-548 in peripheral neuropathic pain, with positive Phase 2 results in painful diabetic peripheral neuropathy reported and plans to advance pivotal development in this area.

In line with its strategy, Vertex continues to explore the development of additional inhibitors targeting specific pain pathways, aiming to offer diverse solutions in both acute and neuropathic pain management.