
FDA approves the non -opioid painkillers drug journavx from vertexpot

On Thursday, the Food and Drug Administration approved the non-opioid pain relievers from Vertex Pharmaceuticals, a new alternative to pain relief that is associated without addiction risk.
Vertex has now been the first drug maker for decades to receive the US approval for a new kind of pain medicine. It is a milestone after a long history of mostly unsuccessful efforts to develop pain relievers without the destructive dependence of cheaper and widespread opioids that have caused a terrible epidemic of abuse and overdose in the USA
The Vertex drug Journavx is particularly approved for the treatment of moderate to severe acute pain, which is usually caused by injuries, operations, illnesses, trauma or painful medical interventions and is probably relaxed over time. According to Vertex, around 80 million patients are prescribed a medication every year for their moderate to severe acute pain in the USA.
Almost 10% of the patients with acute pain, which are initially treated with opioid, will continue to have longer use of opioids, and around 85,000 people will develop opioid consumption disorders annually, said Vertex in an explanation.
“We have the opportunity to change the paradigm of acute pain management and create a new supply standard,” said Dr. Reshma Kewalramani, CEO von Vertex, in an explanation.
According to Vertex, Journavx will have a list price of $ 15.50 per 50 milligram pill. Wall Street analysts have announced that the medication could become a blockbuster drug if it gains the approval of supervisory authorities, and the estimate of annual sales could exceed $ 1 billion.
The experience of the pain begins in a nerve end, and the body recognizes the pressure and sends a signal to the spinal cord and then to the brain. The treatment of Vertex blocks by blocking pain signals on their origin before reaching the brain. This differs from opioids that act directly on the brain to block pain and trigger the brain's reward centers in a way that addiction can feed.
The approval underlines the “Commitment of the FDA to approved safe and effective alternatives to opioids for pain management,” said Dr. Jacqueline Corrigan-Curay, deputy director of the FDA Center for Pharmaceutical Assessment and Research, in an approval.
The pain reliever from Vertex was more effective than a placebo to reduce the intensity of the pain after 48 hours in two studies in the late stage of more than 1,000 patients who had abdominoplasties, also known as “abdominal People applied with acute pain.
However, the pain reliever did not achieve the secondary goal in both studies to reduce pain compared to a combination of the frequently abused opioid drug hydrocodons and paracetamol, the basis for popular painkillers such as Tylenol.
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In both studies, the rates of adverse side effects were among those who received the drug from Vertex, compared to people who took a placebo. According to the FDA, the most frequently reported undesirable events in people who received journavx were itching, muscle cramps and rash.
In a separate phase three study, more than 83% of patients stated in a survey that the medication was good, very good or excellent in loosening pain. These people had subjected various surgical or non -surgery interventions.
The greater chance for Vertex could be to gain the FDA approval in chronic pain. This is an area in which the risk of addictive opioids, according to the centers for the control and prevention of diseases, can be higher.
In 2023, the company's pain reliever delivered positive results in a study with a medium level in diabetes patients with chronic nerve disease.