FDA approves Vertex Non-Opioid Painkiller Medicines Journal

Food and Drug Administration approved Thursday Vertex Pharmaceuticals’ Non-Opioid painkiller pill, A new alternative For pain relief that comes without the risk of addiction.

Vertex is now the first fabric machine for decades to get us approval for a new type of pain medication. It’s a milestone after a long story with mostly failed endeavors To develop painkillers without the destructive dependence on cheap and widely available opioids that have caused a terrible epidemic of abuse and overdose in the US

Vertex’s Medicines, Journal, are specifically approved for the treatment of moderate to severe acute pain, which is usually caused by injury, surgery, illness, trauma or painful medical procedures and probably facilitates over time. Around 80 million patients is prescribed a medication for their moderate to severe acute pain every year in the United States, according to Vertex.

Almost 10% of patients with acute pain originally treated with an opioid will continue to have prolonged opioid use, and approx. 85,000 people will develop opioid disorders annually, Vertex said in a statement.

“We have the opportunity to change the paradigm of acute pain management and establish a new standard for care,” Dr. Reshma kewalramani, vertex ceo, in a declaration.

Vertex said Journavx will have a list price of $ 15.50 per day. 50-Millram pill. Wall Street analysts have said the medicine could become a blockbuster drug if it wins the approval of regulators, estimating that its annual sales could exceed $ 1 billion.

The experience of pain starts in a nerve ending and the body detects the pressure and sends a signal to the spinal cord and then the brain. Vertex’s treatment works by blocking pain signals by their origin before reaching the brain. It is different from opioids that act directly on the brain to block pain, which triggers the brain’s reward centers in a way that can feed addiction.

The approval emphasizes “FDA’s obligation to approve secure and effective alternatives to opioids to pain management,” Dr. Jacqueline Corrigan-curay, acting director of the FDA Center for Drug Evaluation and Research, in a release.

Vertex’s painkillers were more effective than placebo to reduce the intensity of pain after 48 hours in Two studies in late stage On more than 1,000 patients who had abdominoplasties, also known as “stomach -tucks”, and about another thousand in people who had bunion surgery. These two procedures are often used in studies of people with acute pain.

However, the pain position did not meet the secondary target of both attempts to reduce pain compared to a combination of opioid medicone hydrocodone, which is often abused, and acetaminophen, the basis of popular pain medication such as tylenol.

In both trials, the rates of adverse side effects were lower in those who received Vertex’s drug compared to people taking a placebo. The most commonly reported side effects among people who received Journavx were itching, muscle spasms and rashes, among others, according to the FDA.

In a separate phase three examination, more than 83% of patients in a study said the drug was good, very good or excellent for ease pain. These people had undergone various surgical or non-surgical procedures.

The greater option for peak may be to win the FDA approval in chronic pain. It is an area where the risk of dependence on prescription opioids can be greater, according to Center for Disease Control and Prevention.

By 2023, the company’s painkillers produced positive results in an intermediate sighting in diabetic patients suffering from a chronic nerve state.