Vertex Non-Opioid Drug Is an Effective Pain Management Medication

January 31, 2024 - On Tuesday, January 30, 2024, Vertex Pharmaceuticals issued a press release announcing that VX-548, its non-opioid pain management drug, effectively reduced pain compared to the placebo across multiple phase 3 clinical trials.

VX-548 is an oral, selective NaV1.8 pain signal inhibitor. By selectively targeting NaV1.8, a genetically validated pain target, the drug can manage acute pain without the use of potentially fatal opioids.

One of the clinical trials focused on patients recovering from abdominoplasty or bunionectomy surgery with moderate-to-severe acute pain. Patients were assigned to one of three groups: the placebo group, a group that received an initial 100 mg dose of VX-548 and 50 mg every 12 hours for 48 hours, or a group that received 5 mg/325 mg of hydrocodone bitartrate/acetaminophen orally every 6 hours over 42 hours.

Using the Numeric Pain Rating Scale (NPRS), researchers evaluated the efficacy of VX-548 based on the time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48). For abdominoplasty patients, the mean difference In SPID48 between VX-548 and the placebo was 48.4 points. Comparatively, the difference for bunionectomy patients was approximately 29.3 points.

In addition, they compared the efficacy of VX-548 with hydrocodone bitartrate/acetaminophen, a standard opioid-based pain management tool. Abdominoplasty patients’ mean difference between VX-548 and HB/APAP was 6.6 points. Additionally, in bunionectomy, the difference was negative 20.2.

Beyond assessing post-surgical pain management abilities, another phase 3 clinical trial evaluated the drug’s impacts for 14 days in surgical and non-surgical acute pain. In that clinical trial, 83.2% of 256 participants reported that VX-548 was good, very good, or excellent at managing pain.

Finally, researchers evaluated the safety and tolerability of the VX-548, noting that the drug was generally safe and well tolerated. None of the reported adverse events were severe, with most mild or moderate.

“We are very pleased with the results from the VX-548 pivotal program, which demonstrate a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings. The VX-548 benefit-risk profile ideally positions it to potentially fill the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential,” said Reshma Kewalramani, MD, Chief Executive Officer and President of Vertex, in the press release. “With FDA Breakthrough and Fast Track Designations in hand, we are working with urgency to file the New Drug Application for VX-548 and bring this non-opioid medicine to the millions of patients who suffer from acute pain each year in the US.”