Vertex Pharmaceuticals, which won FDA approval in January to sell the opioid-free acute pain reliever Journavx, has run into a roadblock in its quest to expand the potential blockbuster to the treatment of multiple types of chronic pain.
In peripheral neuropathy (PNP), a chronic pain disorder that results when nerves outside of the brain and spinal cord are damaged, Vertex is seeking a broad indication for Journavx (suzetrigine). The company has been conducting clinical trials of Journavx in two subgroups of the disease, including lumbosacral radiculopathy (LSR) and diabetic peripheral neuropathy (DPN), in the hopes that it will be able to accrue a wide nod in the PNP ground in one fell swoop.
Regarding the regulatory side of things, Kewalramani said that Vertex has been having productive discussions with the regulator regarding its PNP program, but “at this point, it does not appear that the FDA can find a route to a broad indication.”
Vertex, in turn, is derailing an effort to launch an LSR phase 3 test of Journavx and has underway a second phase 3 trial of the discomfort med in DPN, intending to focus that particular indication in its PNP regulatory submission application, the CEO described.
Journavx has a breakthrough FDA therapy label in DPN, Kewalramani said during the call. According to a presentation on Vertex’s investor site, accessed earlier this year, approximately 2.4 million people live with the condition in the U.S.
Regarding the route to additional PNP nods, Vertex now intends to be “DPN first, then add on single indications, but work with the [FDA] to get to broad PNP,” Kewalramani said.
Although, as Kewalramani made clear, the FDA does not see a path to PNP for Journavx right now, the regulatory agency does see a roadblock-free way forward on DPN.
Regarding the broader trajectory of Vertex pain development, including whether Vertex might someday develop larger markets in the chronic pain space, including joint pain, Kewalramani instructed analysts, as it concerns the pain portfolio overall, that “we are quite laser focused, first on acute and then neuropathic [pain]. We will come to the musculoskeletal, but I am not seeing that in the top priorities.”
In late January, Journavx achieved a first-of-its-kind FDA approval as a non-opioid treatment avenue for acute pain. By portraying the drug as a possible remedy to the addiction and overdose epidemic that has been following the popularisation of narcotic pain relievers in the U.S., Vertex has framed the drug as a potential cure.
Taken orally, it is a voltage-gated sodium channel (NaV) inhibitor that can be used to block the sensation of pain by acting on a signaling pathway within the peripheral nervous system.
The green light that Vertex secured–very much in acute pain–was to have the FDA approve the drug in a broad PNP indication–an estimated population of around 11 million U.S. patients–based on positive trial data in LSR and DNP, which comprise about 60 percent of all PNP patients, said Vertex chief operating officer Stuart Arbuckle last year.
The sodium channel inhibitor VX-993, slated as a successor to Journavx, was found to be no better than a placebo in a mid-stage study in which it was used to treat adults who had undergone surgery to remove bunions. The asset did not even reach the top scorers in the trial placebo arm at three doses, and hence, Vertex is abandoning the development of VX-993 as a monotherapy agent in acute pain.
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