Vertex eyes FDA decision on non-opioid pain drug in January

Vertex Pharma has filed for FDA approval of its non-opioid pain drug suzetrigine, starting the clock ticking on a review that should be completed early next year.

The FDA has granted a priority review to the application, as well as fast-track and breakthrough status, and is due to deliver its decision by 30th January next year. If approved, suzetrigine (formerly known as VX-548) would be the first new class of medicine to treat acute pain in more than two decades.

That means it could become an important therapy, free of the side effects and risk of dependency that accompanies the use of opioids, which has fuelled an epidemic of overdose deaths in the US and other countries around the world. Drug overdose deaths in the US exceeded 100,000 in 2023 for the first time, according to Centers for Disease Control and Prevention (CDC) figures.

Suzetrigine is an oral drug that targets NaV1.8 sodium channels, which are thought to play a role in relaying pain signals to the spinal cord from peripheral nerves.

In two phase 3 trials, the drug was shown to be significantly more effective than hydrocodone plus acetaminophen at achieving pain relief within 48 hours of abdominoplasty and bunionectomy surgery, with pain relief typically kicking in within just two to four hours.

"In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain," commented Scott Weiner, of Harvard Medical School and Brigham and Women's Hospital, who is chair of Vertex's acute pain steering committee.

"Too many people today are either undertreated, dealing with negative side effects of currently available therapies, or foregoing pain medications altogether for fear of becoming dependent on opioids," he added. "Prescribers and patients deserve new options."

The acute pain setting is huge, with approximately 80 million patients prescribed a medicine for moderate-to-severe acute pain each year in the US, roughly half of whom are treated in institutional settings, and analysts have suggested suzetrigine has the potential to become a multibillion-dollar product.

Vertex has said it plans to focus on institutional prescribers initially if suzetrigine reaches the market – particularly orthopaedic, general, and plastic surgeons, emergency department physicians, anaesthesiologists, and pain medicine specialists – and is already in discussions with payers over formulary access.

Meanwhile, the company is planning a pair of phase 3 trials in painful diabetic peripheral neuropathy in the second half of this year, which if positive could extend the use of the drug into another indication with massive unmet need. It is also studying the drug in a mid-stage trial in lumbosacral radiculopathy (LSR), a peripheral neuropathic pain (PNP) condition with no approved treatments.