Thursday, the Food and Drug Administration approved Vertex Pharmaceuticals, a new alternative to pain relief without the danger of addiction.
Vertex is now the first pharmaceutical producer who has been approved for new types of painkillers for decades. After a long long history of developing painkillers without the destructive dependence of opioids that are inexpensive and widely available, they have caused terrible abuse and overdose in the United States.
Journavx, a vertex drug, is usually approved for the treatment of severe acute pain, which is generally caused by injuries, surgery, disease, trauma or painful medical procedures and may be relaxed over time. According to Vertex, about 80 million patients are prescribed by medication for severe acute pain every year.
Nearly 10%of patients with acute pain for the first time in opioid will continue to use Opioids, and about 85,000 people will develop opioid disorders every year.
“We have the opportunity to change the paradigm of acute pain management and establish new treatment standards,” said Reshma Kewalramani, Vertex CEO.
Vertex said Journavx’s list price would have a $ 15.50 list price per 50 milligram pills. Wall Street analysts said that if drugs are approved by regulators, the drug can be blockbuster drugs, and annual sales can exceed $ 1 billion.
The experience of pain begins with the nerve ending, the body detects pressure and sends signals to the spinal cord and brain. Vertex’s treatment works by blocking pain signals from the origin before reaching the brain. It is different from opioids that cause the brain’s compensation center by acting directly on the brain and blocking pain and supplying addiction.
This approval emphasizes “FDA’s promise to approve safe and effective alternatives to opioids for pain management.”
Vertex’s painkillers were more effective than placebo for reducing pain strength after 48 hours after 48 hours. More than 1,000 patients with abdominal ingredients, more than 1,000 patients who are also called “tummy tucks”, and about a thousand people who have undergone BUNION surgery. . These two procedures are generally used in the research of people with acute pain.
However, paykiller did not meet the secondary goals in two tests of pain reduction compared to the combination of the frequently abused Opioid Drug Hydro Codon, which is the basis of popular painkillers such as acetaminophen and tylenol, which are often abused.
In the two exams, the proportion of side effects was lower in those who received the peaked drug than those who took placebo. According to the FDA, the most commonly reported side effects among those who received Journavx were itching, muscle spasms and rashes.
In a separate three -stage study, the survey said in a survey that more than 83% of patients are good or excellent for pain relief. They have experienced a variety of surgical or non -surgical procedures.
Vertex’s bigger opportunity is to get FDA approval from chronic pain. According to the Centers for Disease Control and Prevention, this is an area where the risk of being addicted to prescription opioids can be greater.
In 2023, the company’s painkillers resulted in positive results in intermediate tests in diabetics suffering from chronic nervousness.
