Vertex Pharmaceuticals’ non-opioid painkiller has accomplished its primary target in late-stage Phase III studies, taking a critical step toward future approval. The Vertex pain relief medication intends to meet the rising demand for effective pain management alternatives, particularly in light of the opioid crisis. The encouraging results come after rigorous testing, bringing renewed hope for a safer and more sustainable solution to chronic pain.
Key Findings from Phase III Trials
The experimental drug reduced post-surgical pain and is claimed to be safe from addiction. Vertex announced Tuesday that the medicine was more effective than a placebo in lowering pain intensity after 48 hours in two late-stage experiments.
When compared to a combination of the opioid medicines hydrocodone and acetaminophen, the treatment did not meet the secondary goal of reducing pain.
Analysts anticipate that the drug will be authorized for the treatment of acute pain, giving a much-needed alternative to addictive opioid painkillers that have caused a national crisis.
The company reported that the drug, VX-548, was safe and well-tolerated in tests involving around 2,400 people. Common side effects were nausea and constipation.
Drug companies such as Eli Lilly and Regeneron Pharmaceuticals have failed to attempt to bring innovative opioid alternatives to market.
The company plans to file for US approval of the drug by mid-2024, which works by blocking pain signals at their source before they reach the brain. An estimate of more than $5 billion will be generated in yearly sales if the drug is approved.
The pharmaceutical company has already abandoned three non-opioid medicines, VX-128, VX-150, and VX-961, following failed Phase I and II studies. Despite the lack of secondary endpoints, this Phase III result is a huge gain for the firm.
Following the positive Phase III study findings, Vertex Pharmaceuticals plans to negotiate the regulatory process for medication approval. The business believes its non-opioid medication will have a positive influence on patient treatment and public health. If authorized, this medicine has the potential to change pain treatment procedures and significantly reduce opioid-related concerns.