NIH on Monday announced it will start enrolling patients in clinical trials to test four potential treatments for long COVID, and said it expects the trials to test at least seven more treatments in the coming months, in today's bite-sized hospital and health industry news from the District of Columbia, Maryland, and Massachusetts.
- District of Columbia: FDA on Tuesday warned that testing from Lupin Pharmaceuticals found two lots of its Tydemy brand birth control pills may be less effective and have therefore been recalled. According to FDA, there are a total of 4,179 boxes that have been recalled, amounting to around 350,000 tablets that could be less effective at preventing pregnancy. The products were distributed nationwide to pharmacies and supermarkets between June 2022 and May 2023. In its warning, FDA said Lupin still advises that patients who are currently taking recalled lots of Tydemy "continue taking their medication. Patients should immediately contact their healthcare provider for advice regarding an alternative contraceptive method." (Tin, CBS News, 8/2)
- Maryland: NIH on Monday announced it will start enrolling patients in clinical trials to test at least four potential treatments for long COVID, and said it expects the trials to test at least seven more treatments in the coming months. In December 2020, Congress provided NIH $1.15 billion to research and test treatments for long COVID. The trials were supposed to start last fall but were delayed three separate times. One trial is currently underway, testing whether a longer regimen of Pfizer's Paxlovid will help long COVID symptoms, while another trial is slated to address brain fog symptoms using brain training software developed by Posit Science Corp. and Mount Sinai Health System and a device for home-based transcranial direct current stimulation developed by Soterix Medical. Other trials will aim address sleep issues, using modafinil and solriamfetol, two wakefulness-promoting drugs, and heart rate, breathing, and digestive activity symptoms, using intravenous immunoglobin therapy and ivabradine. (Cohrs, STAT, 7/31; Weixel, The Hill, 7/31)
- Massachusetts: Two phase II trials published Wednesday in the New England Journal of Medicine found that VX-548, a drug developed by Vertex Pharmaceuticals that blocks signals from pain-sensitive neurons before the signals can reach the brain, was able to reduce pain in two different groups of patients — one where patients had bunion surgery and another where they had an abdominoplasty. A commentary accompanying the study noted that, while the pain reduction measured in the study was statistically significant, the treatment effect was "small" and it's unclear how meaningful the benefits of the drug were to patients. However, the study authors noted participants who took VX-548 were less likely to stop their treatment early because it wasn't working than those on a placebo or those given acetaminophen and hydrocodone. (Wosen, STAT+ [subscription required], 8/2; George, MedPage Today, 8/2)