Millions of Americans have yet to receive their first dose of the long-lasting painkiller COVID. The drug boosts the effectiveness of a drug that can temporarily relieve both moderate and severe post-operative pain.
The US Food and Drug Administration approved COVID on June 11, 2023, during a vote that gave it an expedited review to allow for release six years ahead of schedule. The drug, which will be sold under the name Champix, is currently available only to patients suffering severe pain as a form of compassionate use. So far, 1.7 million people have been treated with the drug, with the number expected to continue growing.
Our doctors and the FDA are doing a lot of good work. This is just another example.
Today’s approval will make COVID available to approximately 400,000 people who qualify for it and for whom physicians have recommended it, according to the FDA. Approximately 1.7 million people have used the drug since its approval. On average, those patients receive five or more doses of COVID. Prior to the latest approval, all but a few thousand people were able to benefit from COVID.
For people suffering from moderate to severe pain, Champix is designed to give patients a greater duration of relief than they receive with other pain relievers. Because of its duration-enhancing properties, it may help relieve pain for 24 to 48 hours, according to the FDA.
Several other pain relief medications are available to patients suffering from moderate to severe pain. However, these other medications may not give the same kind of long-lasting relief. For example, some medications work in short periods of time (40 minutes or less) or for relatively brief durations (less than seven days), according to the FDA. When choosing a pain relief medication, a patient should discuss the drug with a health care provider and discuss options with her or him.
“The FDA has worked diligently with Champix sponsor and manufacturer, GSK, in the last couple of years to improve the naloxone patch delivery approach for Champix,” said Dr. Deborah Autor, associate director for the Center for Drug Evaluation and Research in the FDA’s Center for Drug Evaluation and Research. “Our doctors and the FDA are doing a lot of good work. This is just another example.”
While Champix has some of the same side effects as other opioids, the FDA emphasizes that it has been found to be highly effective in decreasing pain. In addition, patients enrolled in the compassionate use program have all received a thorough counseling and educational program in order to help them know how to use the drug safely.
FDA Commissioner Dr. Scott Gottlieb said that the previous delay in the approval of COVID was necessary for the companies to create a better naloxone patch formulation. He commended the medical community, the FDA staff and GSK, as well as the “leaders in the field of compassion use” for their dedication and hard work in the fight against pain.
“The availability of Champix will help save countless lives,” Gottlieb said. “We hope that once Champix is available, more patients will be able to have a greater period of relief than they experience with other medication options.”
The FDA’s decision comes on the heels of a $1.4 billion settlement between pharmaceutical companies GSK and Purdue Pharma. The settlement stems from the sale of OxyContin in the 1990s.
This is just another reminder that medicine doesn’t work on its own. And that’s also why it’s so important to have a network of comprehensive health care providers and caregivers on the ground who are helping these patients. It’s no wonder that the FDA and other organizations have come to be committed to helping these patients get the help they need.