Vertex begins bid for US approval of non-opioid painkiller
18 Apr 2024
Phase 3Phase 2
Vertex Pharmaceuticals is vying for approval of an experimental and closely watched painkiller that could become an alternative to addictive opioids like Vicodin.
On Thursday, the biotechnology company said the Food and Drug Administration granted a so-called rolling review of the drug, a pill previously known as VX-548 and now suzetrigine, in moderate-to-severe acute pain. Vertex has already started the process and expects to complete an approval filing in the second quarter.
Suzetrigine is an important drug for Vertex, which has spent years trying to branch out from the cystic fibrosis medicines that account for much of its revenue. The drug has already succeeded in the types of Phase 3 studies several other would-be pain therapies have failed in recent years, positioning itself as the first of what could be a new class of medicines that don’t have the addictive properties of opioids.
Some analysts believe suzetrigine could generate billions of dollars in peak annual sales if approved, much more than the gene editing treatment Vertex brought to market last year.
Thursday’s announcement brings that potential outcome a bit closer. The FDA has already given the company certain designations meant to speed up the review process, which typically takes six to ten months. A “rolling” review also enables a developer to work hand-in-hand with regulators in an often faster and more collaborative process.
“Today marks a significant milestone on our journey to redefine the treatment of pain,” said Carmen Bozic, Vertex’s chief medical officer, in a statement. “Given the favorable benefit/risk profile demonstrated by suzetrigine across the entire clinical program and the positive interactions with regulators, we are excited by the opportunity to rapidly advance suzetrigine, a new non-opioid potential treatment, for the millions of patients suffering from acute and peripheral neuropathic pain.”
Suzetrigine still faces questions. The drug missed a key secondary goal in Phase 3 trials in acute pain, failing to prove more effective than a combination of Tylenol and a widely prescribed opioid. That finding, as well as the potential that insurers could require prior authorization before approving treatment, may “cap its usage” in the post-operative setting, RBC Capital Markets analyst Brian Abrahams wrote in a note to investors earlier this month.
Abrahams believes peak annual sales in acute pain will only reach about $400 million annually, substantially lower than consensus analyst estimates of about $2 billion.
“We continue to see a good likelihood of approval, given sufficient data and the need for opioid sparing pain drugs, though we remain much more cautious on the market opportunity,” Abrahams added in a note on Thursday.
Commercial prospects for the drug could be higher if it succeeds in other forms of pain. Vertex on Thursday disclosed plans to run two late-stage trials in diabetic peripheral neuropathy, a larger indication in which suzetrigine showed promise in earlier testing. The company also expects to finish enrolling participants in a Phase 2 trial in lumbosacral radiculopathy, a form of chronic pain, by the end of the year.
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