Vertex Achieves Success in Phase III Trials for Pain Drug, Eyes NDA Submission

Vertex Pharmaceuticals has reported a significant breakthrough with its non-opioid pain medication, VX-548, which has successfully passed three Phase III trials, showing considerable efficacy in reducing pain for both surgical and non-surgical patients.

In two pivotal studies, VX-548 was administered to individuals who had undergone abdominoplasty or bunionectomy. The medication was assessed based on the time-weighted sum of pain intensity differences from 0 to 48 hours post-surgery, known as SPID48. The results were remarkable, with VX-548 significantly outperforming placebo in both trials, achieving a p-value of less than 0.0001 for abdominoplasty and 0.0002 for bunionectomy.

Patients in these trials also experienced a substantial reduction in pain 48 hours after treatment, as measured by the Numeric Pain Rating Scale (NPRS). Moreover, VX-548 provided faster pain relief compared to placebo, with a median onset time of two hours for abdominoplasty patients and four hours for those who underwent bunionectomy, in contrast to the eight-hour median onset for placebo recipients.

The third Phase III trial, which focused on the safety and efficacy of VX-548, confirmed its effectiveness in managing various types of pain. The Patient Global Assessment tool indicated that 83.2% of patients found VX-548 to be effective in treating their pain.

Reshma Kewalramani, CEO of Vertex, highlighted the drug's favorable benefit-risk profile, which could bridge the gap between medications with limited efficacy and opioids, which carry the risk of addiction. Vertex is actively preparing to submit a New Drug Application for VX-548, with an expected filing date by mid-2024, aiming for a broad label indication for moderate-to-severe acute pain.

Additionally, Vertex is targeting a broad label for VX-548 in peripheral neuropathic pain, following promising Phase II results in December 2023. The treatment showed a significant reduction in self-reported pain in diabetic peripheral neuropathy patients, as measured by the NPRS. The company is now gearing up for pivotal development for this indication.

VX-548 is an orally available selective inhibitor of the NaV1.8 sodium channel, a critical component in peripheral pain signaling. Its development could mark the first new class of pain treatments in over two decades, as suggested by a Vertex spokesperson in August 2023.

The successful trials of VX-548 represent a significant step forward in pain management, offering a potentially safer and more effective alternative to opioids for patients in need of acute pain relief.