About the pain medicine
The pain medicine is given as a tablet with a prolonged release in humans. It is somehow similar to morphine or other strong opioids. It should only be taken if you would be in severe pain without taking a strong pain medicine.
The pain medicine with its immediate and prolonged release formulation has been researched in adults- for different types of pain such as acute post-surgical pain and chronic pain conditions such as lower back pain and cancer pain. These trials showed that the pain medicine has shown efficacy in treating moderate to severe pain and it is well tolerated. Based on these data the pain medicine has been approved for the use in adults. Today it has been used for more than 140 million patient treatment days in adults.
So far, only limited data are available in children. 2 studies have been completed in children within the age range from 2 to less than 18 years old. These children (100) received one single dose of the pain medicine only.
The RELYON study is aiming to learn more about this prolonged release pain medicine in children with long-term pain - and hopefully- the information gained will allow us to make it available for children in the future as well.