Vertex bags FDA okay for its non-opioid pain drug
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Vertex Pharma has secured FDA approval for its non-opioid pain drug suzetrigine, becoming the first new class of pain medicine in the US in more than 20 years.
The oral NaV1.8 inhibitor has been cleared under the Journavx brand name with a broad label to treat adults with moderate-to-severe acute pain - for example, after trauma or surgery - and works by blocking a pain-signalling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.
Suzetrigine has been held up as potentially a major asset in the fight against the ongoing opioid crisis in the US, as it tackles pain without any evidence that it can lead to addiction. Over 80 million Americans are prescribed medicine to treat their moderate-to-severe acute pain every year, and half of them are prescribed an opioid, according to Vertex.
The new product will launch at a list price of $15.50 per 50mg pill, said Vertex. Treatment requires two pills per day, after a starting dose of 100mg.
The next challenges for the company will be winning formulary access, arguing that the drug will be less likely to lead to opioid use disorder (OUD) than opioid-based painkillers like oxycodone and hydrocodone, and convincing physicians to shift their prescribing habits. It estimates that almost one in 10 acute pain patients who start treatment with an opioid go on to use them for a prolonged period.
Journavx's approval is an "important public health milestone," according to Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research (CDER).
"A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option," she added. 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.
Journavx is the first new-mechanism pain drug approved in the US since TerSera's N-type calcium channel blocker Prialt (ziconotide, formerly sold by Elan and Jazz Pharma) was given a green light in 2004 for severe chronic pain.
Its approval is based on positive results in phase 3 trials involving patients undergoing abdominoplasty (tummy tuck) or bunionectomy procedures. In the trials, Journavx was shown to be significantly more effective than hydrocodone plus acetaminophen at achieving pain relief within 48 hours, with pain relief typically kicking in within just two to four hours.
Vertex also has the ambition to extend the use of suzetrigine into the chronic pain setting, but the results of a phase 2 trial involving patients with lumbosacral radiculopathy, a form of chronic, neuropathic pain, disappointed investors and led to a sell-off in its shares.
Along with LSR, Vertex is also running a trial of suzetrigine in painful diabetic peripheral neuropathy (DPN), another form of chronic, neuropathic pain.