Tramadol Hydrochloride

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. '

A biotech developing what it says is an “opioid-like” pain reliever released Phase 3 data Wednesday morning claiming the drug can reduce post-operative pain for patients who received abdominoplasty surgery, also known as a “tummy tuck.” Tris Pharma said patients who took 400 µg of their drug cebranopadol once per day — for only two days — experienced a statistically significant reduction in pain intensity versus placebo (p-value of <0.001). The company also said there were no serious adverse events related to the drug, and the most common side effect was nausea. Cebranopadol is an experimental drug that is designed to activate two receptors in the nervous system and brain. The first is called the μ-opioid peptide (MOP) receptor, which is the same pathway painkillers like Vicodin and morphine use in creating their sedative and analgesic effects. The second is known as the dual nociceptin/orphanin FQ peptide (NOP) receptor, which some researchers believe has a “modulatory role” on MOP receptor effects while still belonging to the broader family of opioid receptors. Tris CEO Ketan Mehta said it’s this dynamic that helps cebranopadol induce pain relief while avoiding the addictive side effects. But Mehta acknowledged it could be a tough sell, given the prominence of the opioid epidemic in the American public consciousness and the Supreme Court case involving the Sackler family last year. And with a regulatory filing expected before the end of the year, the company still has to convince the FDA. “We like to think that this is not an opioid, but of course, FDA will have to agree with us,” Mehta said in an interview. “We hope that … the strength of the data and the growing body [of evidence] will indicate and convince FDA that this is a different class of a drug.” Tris does have backing from the NIH, which gave the company a five-year grant to research this dual mechanism of action in opioid use disorder and other substance abuse disorders. Mehta said Tris has conducted studies pitting cebranopadol head-to-head against highly addictive opioids like oxycodone and Tramadol, showing its drug has less risk for abuse. Harold Minkowitz, the lead investigator for the study that read out Wednesday, said he had some trepidation before agreeing to run the trial. But he said the drug can provide an “opioid-like potency” and should have a role to play in new pain relief alongside other companies working on non-opioid drugs like Vertex, which has a PDUFA date for the NaV1.8 signal-targeting suzetrigine next week. “Obviously people will hear about it and have concerns, but I think the data will speak for itself,” Minkowitz said. “And I think when people do the research, as I did, because I would have an equal trepidation myself … they’ll see what the data shows.” The company is also expected to report data from another Phase 3 study in the coming weeks, testing cebranopadol use after surgical bunion removal.