A sign hangs in front of the world vertex headquarters Pharmaceuticals in Boston.
Brian Snyder | Reuters
The food and medication administration approved on Thursday the non -opioid analgesic pill of VERTEX Pharmaceuticals, a new alternative for the relief of pain that comes without the risk of addiction.
VERTEX is now the first drug manufacturer in decades to obtain the approval of the United States for a new type of pain medicine. It is a milestone after a long history of mostly failed efforts to develop analgesics without the destructive dependence of cheap and widely available opioids, which have caused a horrible epidemic of abuse and overdose in the United States.
The medication of VERTEX, Journavx, is specifically approved for the treatment of moderate to severe pain, which is generally caused by injuries, surgery, disease, trauma or painful medical procedures and probably decreases over time. According to vertex, a medicine was prescribed to around 80 million medications for their acute pain from moderate to severe every year in the United States.
Almost 10% of acute pain patients who are initially treated with an opioid will have prolonged opioid use, and approximately 85,000 people will develop opioid use disorder annually, Vertex said in a statement.
“We have the opportunity to change the paradigm of acute pain management and establish a new standard of attention,” said Dr. Reshma Kewalramani, CEO of Vertex, in a statement.
VERTEX said Journavx will have a list price of $ 15.50 per 50 milligrams pill. Wall Street analysts have said that the medicine could become a great success if the approval of regulators gains, estimating that their annual sales could exceed $ 1 billion.
The pain experience begins in a nervous end, and the body detects the pressure and sends a signal to the spinal cord and then to the brain. The vertex treatment works by blocking pain signals at its origin before reaching the brain. That is different from opioids, which act directly on the brain to block pain, which triggers brain rewards centers in a way that can feed addiction.
The approval underlines the “FDA commitment to approve safe and effective alternatives to opioids for pain management,” said Dr. Jacqueline Corrigan-Curay, Interim Director of the FDA Drug Evaluation and Research Center, in a release.
The vertex analgesic was more effective than placebo to reduce pain intensity after 48 hours in two studies in late stage in more than 1,000 patients who had abdominoplasties, also known as “abdomenal”, and approximately another thousand in people who were They submitted to Bunion surgery. These two procedures are commonly used in studies of people with acute pain.
However, the analgesic failed to achieve the secondary objective in both trials to reduce pain compared to a combination of opioid drug hydrocodone, which is often abused, and acetaminophen, the base of popular pain medications such as The Tylenol.
In both trials, adverse side effects rates were lower in those who received the vertex medication compared to the people who took a placebo. The most commonly reported adverse events among the people who received Journavx were itching, muscle spasms and eruption, among others, according to the FDA.
In a separate study of phase three, more than 83% of patients said in a survey that the medicine was good, very good or excellent to relieve pain. These people had undergone several surgical or non -surgical procedures.
The greatest opportunity for the vertex can be to gain the approval of the FDA in chronic pain. That is an area where the risk of prescribed opioid addiction can be greater, according to disease control and prevention centers.
In 2023, the company's analgesic produced positive results in a medium stage trial in patients with diabetes suffering from a chronic nervous condition.
