The signboard is displayed in front of the world headquarters of Boston’s vertex drugs.
Brian Snider | Reuters
The Food and Pharmaceutical Affairs Bureau on Thursday has approved non -opioids of Pharmaceuticals at the top. Painkiller pill, New alternative To relieve the pain that comes without the risk of poisoning.
Vertex is the first drug maker for the first time in decades and has obtained a new type of painful drug. Mile stone after a long history Almost failed efforts Develop a painkiller without the inexpensive and widely available opioido -dependent. Terrifying trend US abuse and overdose
Journavx, a Vertex drug, is usually caused by injuries, surgery, illness, trauma, or painful medical treatment, and is particularly likely to be alleviated over time, to the treatment of severe acute pain. Approved. Around 80 million patients According to the top, the United States prescribes severe acute pain drugs every year.
At first, almost 10 % of patients with acute pain treated with opioids continue to extend the use of opioids, and about 85,000 people develop opioid use every year. Vertex states in a statement.
“We have the opportunity to change the paradigm of acute pain management and establish new standard care,” said Dr. Reshma Kewallramani, the vertex CEO. statement。
According to Vertex, JOURNAVX has a fixed price of $ 15.50 per 50 milligram. Analysts in Wall Street stated that if the approval from regulatory authorities, the drug could be a huge hit, and it is estimated that annual sales may exceed $ 1 billion. 。
Pain experience begins at the end of the nerve, the body detects pressure, sends a signal to the spinal cord and the brain. The treatment of the vertex works by blocking the signal of pain before reaching the brain. This is caused by an opioid that directly acts on the brain and hinders pain, and is caused by a method that can supply the brain reward center to addiction.
Dr. Jacqueline Corrigan-Curay, a representative director of the FDA drug evaluation research center, emphasized the FDA commitment to approve the safe and effective alternative of the opioid for pain management.
The peak painkillers were more effective than the placebo to reduce pain strength 48 hours later. Two late research Approximately 1,000 patients who have undergone abdominal plastic surgery, which are also known as “tummy tacks”, and about 1,000 patients who have undergone surgery. These two steps are commonly used in research on acute pain.
However, painkillers have a second goal in both examinations: reducing pain when compared to the combination of the frequent abuse of the opioid drug Hydrokodon and the acetaminophen, which is the basis of general analgesics such as chirenol. I couldn’t achieve it.
In both exams, compared to those who took placebo, the percentage of side effects of side effects was lower for those who received the peak medicine. According to the FDA, the most commonly reported adverse events among those who received Journavx were, especially muscular convulsions and rashes.
Another phase 3 study said that more than 83 % of the patients were investigated, stating that the drug was good to alleviate pain, very good or excellent. These people had a variety of surgical or non -surgical measures.
The big opportunity at the top is to get FDA approval with chronic pain. It is a field where the risk of addiction of prescription opioids may increase. Disease Control Prevention Center。
In 2023, the company’s painkillers gained positive results in the mid -term exam of a diabetic patient suffering from chronic nervous state.
