Boston Pharmaceuticals’s world headquarters hangs a sign.
Brian Snyder | Reuters
Food and Drug Administration approved on Thursday VertexNon -opioids Analgesic pill, A new choice Reduce pain without the risk of addiction.
Vertex is now the first pharmaceutical who has obtained a new type of painkillers in decades. This is a milestone after a long history Mainly the unsuccessful effort Develop painkillers without cheap and widely available opioid drugs, which leads to Terrible epidemic Abuse and excess of the United States
Vertex’s drug Journavx is specifically approved to treat moderate to severe acute pain. This is usually caused by medical procedures of injury, surgery, disease, trauma or pain, and may be relieved over time. About 80 million patients According to Vertex, in the United States, every year, for their moderate to severe acute pain prescriptions.
Wall Street analysts said that if the drug has won the approval of the regulatory agency, the drug may become a sensational drug, and it is estimated that its annual sales may exceed $ 1 billion.
The experience of pain begins with the end of the nerve, the body detects the pressure, and signals to the spinal cord and the brain. The treatment method of the vertex is to use the pain signals that prevent the origin from the origin before reaching the brain. Unlike opioids, opioids directly act on the brain to block pain, and a reward center that can cause the brain in a way to feed addiction.
Dr. Jacqueline Corrigan-Curay, the acting director of the FDA Drug Evaluation and Research Center, said the approval of the approval emphasizes “the commitment of FDA for the safety and effective alternative of approved opioids.”
Vertex’s painkillers are more effective than placebo, reducing the strength of pain after 48 hours Two post -research For more than 1,000 patients with abdominal tumors, also known as “belly plugs”, about tens of thousands of patients with Bunion surgery. These two programs are usually used for the research of people who are acute pain.
However, compared with the combination of hydrogen ketone and acetaminophenophenophenophenophenophenophenophenophenophenophenophenophenophenophenophenophenophenophenophenophenophen phenolic phenolic phenolic phenolic phenol, neither of the trials that reduce pain have achieved secondary goals. The foundation.
In these two experiments, the incidence of adverse side effects of those who received the drugs of the drug was lower than those who received the placebo. According to FDA, the most common bad events from people who received Journavx are itching, muscle spasm and rash.
In another third stage study, more than 83 % of patients said in one survey that the drug was good and could relieve pain. These people have accepted various surgery or non -surgical procedures.
The greater apex opportunity may be the FDA approval of the chronic pain. According to this field, the risk of addiction to prescription opioids may be greater. Disease Control and Prevention CenterEssence
In 2023, the company’s painkillers achieved positive results in mid -term trials of diabetic patients with chronic neuropathy.
