Suzetrigine

Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug its been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year.The drug is a reformulated version of an old medication, meloxicam, designed to more quickly treat the sharp, acute pain felt after an injury or operation. Researchers evaluated the drug in a dental pain study in 2022. Not long after, a pair of late-stage clinical trials began assessing it in nearly 1,000 people who had just undergone either a bunion removal or a hernia repair surgery.Results from those trials, according to Viatris, now show that pain scores improved substantially more for participants given the drug rather than a placebo. The main goal of both experiments revolved around a scoring system that measures pain intensity over a two-day period. Its the same system Vertex Pharmaceuticals used in the studies that ultimately led to the approval of Journavx, a closely watched, non-opioid pain reliever.Viatris, like Vertex, also set up arms in its trials to compare the relief provided by its drug to that of an opioid. The company said after-the-fact analyses found the drug offered significantly superior pain control to tramadol. The amount of time it took for participants to sense some pain reduction and to classify that reduction as meaningful was also comparable between the two groups and, in some cases, shorter for those on Viatris therapy.Journavx did not significantly outperform the opioid arms in Vertexs studies, though those used a combination of Tylenol and a more potent opioid, hydrocodone.Additionally, Viatris said that during the main treatment phase of its studies, there was a notable reduction in opioid usageas well as a higher number of opioid-free patients in the drug group as opposed to the placebo group. Patients also generally tolerated the drug well. There were few so-called severe treatment emergent adverse events, and the incidence of them was comparable across the two groups.All this evidence optimally positions Viatris drug to become a first-line treatment for moderate-to-severe acute pain, according to Philippe Martin, the companys research and development head. “The data observed ... is a critical step in the development of a safe and effective non-opioid option to address an important public health need, he said in a statement.The trial results were released alongside Viatris first quarter earnings report. The company, which officially formed in 2020, when Mylan merged with Pfizers Upjohn unit, recorded $3.3 billion between January and March, an 11% decrease from the same period a year prior. Viatris shares were up over 10% late Thursday morning, to trade around $9.48 apiece.Shares of Vertex, meanwhile, were down more than 2%, capping off a week in which the company lost tens of billions of dollars in value thanks, in part, to an earnings report that disappointed investors.Michael Yee, a Jefferies analyst who covers Vertex, wrote in a note to clients that first quarter revenue and earnings per share were light. But what stood out was the company saying Journavx revenue was “insignificant during the period, even though cumulative prescriptions had grown to around 25,000 by late April.Brian Skorney, a Baird analyst who also follows Vertex, wrote in his own note that the new Viatris data highlight a number of concerns we have with Journavxs profile, in particular, onset of action, a critical factor for post-operative pain.Skorney went on to suggest the respective bunionectomy studies make Journavx look like an inferior option compared to a pretty old albeit new and fast-acting non-steroidal anti-inflammatory drug, or NSAID.If NSAID's don't have the highest efficacy, as Vertex is fond of saying, what does that say about Journavx? he wrote. '

Vertex's momentum for its two new launches were partly overshadowed by a loss of Trikafta sales in Russia. For Vertex Pharmaceuticals, the first quarter of 2025 brought good news and bad news. On the bright side, early momentum for newly launched cystic fibrosis (CF) med Alyftrek and pain treatment Journavx contributed to a U.S. revenue boost and the company's increased 2025 outlook. But, on the other hand, a unique generics situation in Russia weighed on the biopharma's international sales. The mixed bag evened out to a 3% year-over-year revenue gain to $2.77 billion, with $1.66 billion coming from the U.S., where Vertex grew sales by 9%.Outside of the U.S., the company's $1.11 billion in first-quarter sales represented a 5% slide from the same period last year.Despite “strong patient demand” in markets outside of the U.S., Vertex's international revenue was impacted by an “expected” decline in Russia, where the company is “experiencing violation of its intellectual property rights,” Vertex explained in its earnings release.“Vertex has strong intellectual property protection for its medicines around the world and believes this violation in Russia is a limited and isolated matter,” the company said.The situation boils down to an unauthorized generic of Vertex’s top-selling CF med Trikafta marketed in Russia. Since January, the Russian Ministry of Health has been switching children who take Trikafta to an Argentina-made generic called Trilexa, independent Russian news publication Okho reported in March, citing stories from parents of patients. The drug has not been tested in clinical studies, and the move has prompted protests within the CF community, according to Okho. As that situation plays out, Vertex’s quarterly revenues came in below consensus expectations of of $2.83 billion, Evercore ISI analysts wrote in a note to clients. BMO analyst Evan Seigerman also cited the “onetime headwinds” from Russia, plus “new product launch noise,” as reasons for the revenue miss.Still, given the trajectory of its two new launches—plus “contributed uptake” of CRISPR Therapeutics-partnered sickle cell and beta thalassemia gene therapy Casgevy—Vertex opted to slightly boost its full-year revenue guidance. Now, the company is eyeing 2025 revenues of $11.85 billion to $12 billion, up from prior guidance of $11.75 billion to $12 billion. Journavx's journey Vertex’s non-opioid Journavx was approved in January to much fanfare considering its unique position as a nonaddictive pain management treatment. The company quickly set out to begin shipments and has since racked up more than 20,000 prescriptions, Vertex reported, although revenue from the drug was “insignificant” during the first quarter because it's still so early in the launch. In his note to clients, Seigerman praised the company's access efforts and said he expects more revenue contributions from the med in the second half of the year.Ensuring patients have access to Journavx is especially key given the cheap generic opioids that currently dominate the pain market.  Alyftrek, meanwhile, won a December FDA approval as a once-daily triple combination for CF patients that have certain mutations. The drug has “potential to set a new standard of CF care,” according to Vertex, which looks to transition patients currently taking established Trikafta over to Alyftrek. So far, the company is seeing “enthusiastic feedback” from physicians and patients, it said in its earnings presentation. The company racked up $53.9 million in Alyftrek revenues in the first quarter.