Viatris' new form of old pain drug scores in large trials
Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it's 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. It's 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 Vertex's 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 usage' as 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 a 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 company's 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 Pfizer's 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 Journavx's 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.
Recommended Reading
Lexicon sells Viatris rights to cardio drug outside of the U.S. and Europe
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Hamilton Spectator
2 hours ago
- Hamilton Spectator
Canadian aid agency workers call for action saying starvation is rampant in Gaza
TORONTO - Canadian aid agencies say malnutrition and starvation is rampant among children in Gaza, as well as among the aid workers trying to help them. The Toronto-based president and CEO at Save the Children Canada said Friday the global agency's clinics are inundated by 200 to 300 people arriving each day. Danny Glenwright said there's been 'a tenfold' increase in the number of children suffering acute malnutrition over the past two months, and that even clinic staff are bringing their children in for help. 'Every single child is now coming in malnourished,' Glenwright said. 'We're also seeing their parents increasingly malnourished and skin-and-bones.' That's echoed by Canada's executive director of Doctors Without Borders, with Sana Beg adding that members of her organization have had to donate their own blood to patients because supplies are so short. Beg said Doctors Without Borders welcomed Canada's recent denunciation of the Israeli government for failing to prevent the humanitarian crisis but called for immediate concrete actions that would open borders to aid trucks carrying desperately needed food and medical supplies. 'Just recently we've had a couple of a handful of trucks that came in with the fuel that was required. A drop in the ocean of needs, really,' said Beg. 'We have no sterile equipment, we have no clean sheets in the hospitals, our hospitals themselves are barely functional, as I said. There is no adequate or safe passage for either civilians, patients, or aid workers to be able to even arrive at medical facilities such as hospitals or clinics.' International experts have warned that a 'worst-case scenario of famine' is playing out in Gaza, where Israel's military offensive against Hamas has made it nearly impossible to safely deliver food to starving people. Glenwright said Friday that Canadians should be upset by the crisis, calling it 'a profound moral, political, and legal failure.' 'There's no food anywhere else in Gaza and the limited supplies we have are running out,' said Glenwright, whose agency has a clinics in Khan Younis and one in Deir al Balah. 'The trucks that are sitting on the border — thousands of them with these life-saving supplies — are not being allowed in at the scale that is required. And it's a calamity.' Several aid agencies detailed a near-total collapse of the humanitarian system in a press conference Tuesday in London that included members of Oxfam, War Child Alliance, Save the Children International in Gaza and the Palestinian Non-Governmental Organizations Network. Prime Minister Mark Carney on Thursday accused the Israeli government of violating international law by denying aid as it controls aid distribution, and called on all sides to negotiate an immediate ceasefire. Beg detailed a catastrophic decline in a region where dire shortages had already forced some doctors to carry out surgeries and limb amputations without anesthesia. 'Today we're talking about a crisis that has magnified tenfold since then,' said Beg, noting premature babies now have to share a single ICU incubator. 'So three or four babies crowded into one incubator at the ICU. Our teams are talking about having to donate their own blood for the patients because there is such a shortage.' Beg said her organization, also known as Médecins Sans Frontières Canada, has about a thousand staff in Gaza, most of them locally hired Palestinians. About 30 to 35 international staff come in for temporary assignments, among them about five Canadians. As malnutrition cases increase, she said staff have had to make gruelling choices over who can be considered dire enough to receive treatment for severe acute malnutrition. Glenwright suggested Canada could do much more diplomatically and economically, noting how strongly the country mobilized to help Ukraine. 'Our government's inability to do more is shameful to all of us,' Glenwright said. 'Canadians can pressure their government – call your MP, say that you want candidates to do much more.' Beg agreed and called on Canadians to inform themselves about the crisis and act. 'Call your local MPs. Write to the Canadian government. Sign petitions,' she said. 'Make your voice heard. Use all of your avenues as a citizen of a democracy to speak truth to power.' – With files from The Associated Press. This report by The Canadian Press was first published Aug. 1, 2025. Error! Sorry, there was an error processing your request. There was a problem with the recaptcha. Please try again. You may unsubscribe at any time. By signing up, you agree to our terms of use and privacy policy . This site is protected by reCAPTCHA and the Google privacy policy and terms of service apply. Want more of the latest from us? Sign up for more at our newsletter page .
Hamilton Spectator
3 hours ago
- Hamilton Spectator
Canadian aid agencies call for action saying starvation is rampant in Gaza
TORONTO - Canadian aid agencies say malnutrition and starvation is rampant among children in Gaza, as well as among the aid workers trying to help them. The Toronto-based president and CEO at Save the Children said Friday its clinics are inundated by 200 to 300 people arriving each day. Danny Glenwright said there's been 'a tenfold' increase in the number of children suffering acute malnutrition over the past two months, and that even clinic staff are bringing their children in for help. 'Every single child is now coming in malnourished,' Glenwright said. 'We're also seeing their parents increasingly malnourished and skin-and-bones.' That's echoed by Canada's executive director of Doctors Without Borders, with Sana Beg adding that members of her organization have had to donate their own blood to patients because supplies are so short. Beg said Doctors Without Borders welcomed Canada's recent denunciation of the Israeli government for failing to prevent the humanitarian crisis but called for immediate concrete actions that would open borders to aid trucks carrying desperately needed food and medical supplies. 'Just recently we've had a couple of a handful of trucks that came in with the fuel that was required. A drop in the ocean of needs, really,' said Beg. 'We have no sterile equipment, we have no clean sheets in the hospitals, our hospitals themselves are barely functional, as I said. There is no adequate or safe passage for either civilians, patients, or aid workers to be able to even arrive at medical facilities such as hospitals or clinics.' International experts have warned that a 'worst-case scenario of famine' is playing out in Gaza, where Israel's military offensive against Hamas has made it nearly impossible to safely deliver food to starving people. Glenwright said Friday that Canadians should be upset by the crisis, calling it 'a profound moral, political, and legal failure.' 'There's no food anywhere else in Gaza and the limited supplies we have are running out,' said Glenwright, whose agency has a clinics in Khan Younis and one in Deir al Balah. 'The trucks that are sitting on the border — thousands of them with these life-saving supplies — are not being allowed in at the scale that is required. And it's a calamity.' Several aid agencies detailed a near-total collapse of the humanitarian system in a press conference Tuesday in London that included members of Oxfam, War Child Alliance, Save the Children International in Gaza and the Palestinian Non-Governmental Organizations Network. Prime Minister Mark Carney on Thursday accused the Israeli government of violating international law by denying aid as it controls aid distribution, and called on all sides to negotiate an immediate ceasefire. Beg detailed a catastrophic decline in a region where dire shortages had already forced some doctors to carry out surgeries and limb amputations without anesthesia. 'Today we're talking about a crisis that has magnified tenfold since then,' said Beg, noting premature babies now have to share a single ICU incubator. 'So three or four babies crowded into one incubator at the ICU. Our teams are talking about having to donate their own blood for the patients because there is such a shortage.' Beg said her organization, also known as Médecins Sans Frontières Canada, has about a thousand staff in Gaza, most of them locally hired Palestinians. About 30 to 35 international staff come in for temporary assignments, among them about five Canadians. As malnutrition cases increase, she said staff have had to make gruelling choices over who can be considered dire enough to receive treatment for severe acute malnutrition. Glenwright suggested Canada could do much more diplomatically and economically, noting how strongly the country mobilized to help Ukraine. 'Our government's inability to do more is shameful to all of us,' Glenwright said. 'Canadians can pressure their government – call your MP, say that you want candidates to do much more.' Beg agreed and called on Canadians to inform themselves about the crisis and act. 'Call your local MPs. Write to the Canadian government. Sign petitions,' she said. 'Make your voice heard. Use all of your avenues as a citizen of a democracy to speak truth to power.' – With files from The Associated Press. This report by The Canadian Press was first published Aug. 1, 2025. Error! Sorry, there was an error processing your request. There was a problem with the recaptcha. Please try again. You may unsubscribe at any time. By signing up, you agree to our terms of use and privacy policy . This site is protected by reCAPTCHA and the Google privacy policy and terms of service apply. Want more of the latest from us? Sign up for more at our newsletter page .
Yahoo
3 hours ago
- Yahoo
Roger Williams, Our Lady of Fatima hospitals sale to move forward. Here's why
PROVIDENCE – Attorney General Peter Neronha announced Thursday, July 31 an amended decision to facilitate the sale of Roger Williams Medical Center and Our Lady of Fatima Hospital. The decision – the second amended in the sale process – reduces the cash-on-hand requirement for the Centurion Foundation, a Georgia-based nonprofit, from $80 million to $45 million for closing the deal. The reduction of cash-on-hand, explained Neronha at a press conference, was due to Centurion having difficulties selling bonds to raise funds for the purchase of the hospitals. But the amended decision also requires Centurion and CharterCARE to secure an additional $35 million within 90 days, bringing the funds back to $80 million. Neronha said the parties have given him assurances on their ability to raise funds post-sale that, in his judgment, could be relied on. The attorney general also said he secured the remaining $50 million – from an original $80 million in an escrow account – to create a hospital fund as part of the transaction. Additional conditions have also been attached to the sale, among them: A requirement for the parties to spend at least $50 million on capital expenses at the hospitals within three years of the transaction A requirement for the parties to not contest the attorney general's right to file a petition for the appointment of a receiver in case of insolvency The detainment of a consultant, at the expense of the parties, to report on the financial and operation state of the hospitals 'While this is a complicated process, our goal is simple: make sure our safety net hospitals are in the best position possible to serve our communities for as long as possible,' Neronha said in a written statement following the press event. Neronha explained that the hospitals were not yet entirely out of danger but that progress has been made: the hospitals are staying provisionally open, are shifting from for-profit to nonprofit and the attorney general's office will have levers to pull in case of an insolvency. 'I don't want to stand here and gaslight Rhode Islanders and make them believer, or have them believe, that all the problems have been solved. They haven't,' Neronha said at the July 31 press conference. 'But we have made some steps forward.' The attorney general added that Rhode Island's chronic low reimbursement rates from public and private insurance need to be addressed to treat the health system's ailments. 'Until we make a Rhode Island patient mean the same financially as a Massachusetts or a Connecticut patient, our hospital systems and our providers and our workers are always going to be at a state of disadvantage,' Neronha said. The anticipated closing date for the sale – pending approval by a bankruptcy court in Texas – is sometime in late August or mid-September. The full amended decision is available here. This article originally appeared on The Providence Journal: Roger Williams, Our Lady of Fatima hospital sales moving forward Solve the daily Crossword
