US-based Vertex Pharmaceuticals has axed plans to progress VX-993 into pivotal development after disappointing Phase II topline results in acute pain.
The NaV1.8 pain signal inhibitor, which progressed into clinical trials as a follow-on from the biotech’s recently approved medication Journavx (suzetrigine), failed to meet its primary endpoint of pain reduction within 48 hours.
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Topline results of the Phase II trial (NCT06619860) revealed that a high dose of VX-993 reduced the time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48) scores by 24.3, which was not a clinically significant reduction compared to placebo.
This result is disappointing compared to the NAVIGATE 2 (NCT06887959) trial of the biotech’s lead NaV1.8-targeting acute pain asset, Journavx, which found the drug could significantly reduce pain post-bunionectomy in patients.
Following this finding, Vertex has decided not to progress VX-993’s development as a monotherapy for patients with acute pain.
This announcement came parallel with an update from Vertex CEO Dr Reshma Kewalramani that the US Food and Drug Administration (FDA) will not provide a broader label for Journavx at this time.
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By GlobalDataThe drug received approval from the FDA in January 2025 for acute pain, and Vertex was hoping to gain approval in peripheral neuropathy (PNP); however, the regulator has said at this time it “does not see a path to a broad indication”. This has sparked Vertex to pause a planned Phase III trial of the drug in lumbosacral radiculopathy (LSR) and instead initiate a second study in DPNM.
Between the Phase II failure and the Journavx setback, Vertex’s stock dropped 13.24%, from a 4 August close of $472.27 to a 5 August open of $409.73. The company has a market cap of $100.96bn.
Post-operative pain market stagnates
In recent years, the pain market has become highly lucrative, with a forecast by GlobalData suggesting that the sector could reach a value of $120.7bn by 2027.
GlobalData is the parent company of Clinical Trials Arena.
The post-operative pain market is also experiencing significant cash flow, with non-steroidal anti-inflammatory drugs (NSAIDs). These include Johnson & Johnson’s Motrimax/Dolormin Duro (naproxen sodium) and Hikma Pharmaceuticals/Kensington Pharma’s Combogesic (acetaminophen and ibuprofen sodium), among others, dominating the space.
There are still opioid drugs retaining dominance in the post-operative pain space, including Talphera’s Zalviso (sufentanil citrate), but the non-opioid-based pathway does seem favourable overall.
Although this indication remains highly profitable, post-operative pain is currently experiencing an innovation slump, with a report from GlobalData revealing that there are no novel formats amid the 28 drugs currently in Phase III development for the indication.
Though Vertex has broken ground with Journavx, there is still a significant need for the development and commercialisation of potent, non-opioid-based therapies to manage this type of condition.
Editors note: This article has been updated to reflect the drugs discontinuation in acute pain.
