The approval of Axsome Therapeutics’ Symbravo for migraine with or without aura came alongside the greenlight for Vertex’s non-opioid treatment Journavx.
The FDA gave the greenlight to Axsome Therapeutics’ Symbravo for the acute treatment of migraine, just hours before approving Vertex’s non-opioid analgesic Journavx for acute pain Thursday.
According to the biotech, Symbravo’s approval opens up a novel multi-mechanistic approach that targets different pathological pathways in migraine. The drug, designed to be taken orally, is indicated for adult patients with or without aura and and is effective for 24-48 hours on a single dose.
In a statement, Axsome CEO Herriot Tabuteau called Symbravo’s approval “an important milestone,” providing migraine patients a “rationally designed novel acute treatment” for their condition.
In an investor note Friday, William Blair analysts said Symbravo has an encouraging market opportunity, with its “differentiated mechanism, which we believe will bode well for marketing the product in a competitive treatment landscape.” Symbravo combines the action of a non-steroidal anti-inflammatory drug and a serotonin receptor agonist.
“We see no reason that patients and physicians would not view Symbravo as a differentiated option for patients refractory” to current treatment options, “but the question for investors will be how large this opportunity is in a salvage therapy position.”
Symbravo’s approval was backed by data from three Phase III studies, MOMENTUM, INTERCEPT and MOVEMENT, which together established the efficacy and safety of the drug at easing migraine pain of varying intensities.
Axsome expects to make Symbravo available to U.S. patients in around four months, according to its news announcement on Thursday.
Also on Thursday, the FDA gave the go-ahead to Vertex Pharmaceuticals’ Journavx—previously known as suzetrigine—as a non-opioid option for patients with severe acute pain. According to the regulator, Journavx represents the first new mechanism of action for the indication in decades, and could help offer patients effective pain relief, without exposing them to the known risks of opioid therapies.
Elsewhere in the pain space, Tris Pharma last week unveiled promising Phase III data for its own non-opioid analgesic cebranopadol, touting a significant reduction in pain intensity versus placebo in patients who had undergone abdominoplasty.
Meanwhile, in February 2024, the pain space welcomed Latigo Biotherapeutics, which launched with $135 million in Series A money and a mission to develop non-opioid therapies against validated genetic pain targets.
