The Role of FDA approves painkiller designed to eliminate the risk of addiction associated with opioids

The Role of FDA approves painkiller designed to eliminate the risk of addiction associated with opioids.WASHINGTON, D.C. — Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin.It's the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to both opioids and over-the-counter medications like ibuprofen and acetaminophen. But the medication's modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain.Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex's drug provided more relief than a dummy pill but didn't outperform a common opioid-acetaminophen combination pill.The new drug will carry a list price of $15.50 per pill, making it many times more expensive than comparable opioids, which are often available as generics for $1 or less.Vertex began researching the drug in the 2000s, when overdoses were rocketing upward, principally driven by mass prescribing of opioid painkillers for common ailments like arthritis and back pain. Prescriptions have fallen sharply in the last decade and the current wave of the opioid epidemic is mainly due to illicit fentanyl, not pharmaceutical medicines.In trying to develop medicines that don't have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain," Vertex's Dr. David Altshuler, told The Associated Press last year.The initial concept to focus on pain-signaling proteins came out of research involving people with a rare hereditary condition that causes insensitivity to pain.Vertex has attracted interest from Wall Street for its ambitious drug pipeline that involves winning FDA approval for multiple drugs across several forms of chronic pain, which generally represents a bigger financial opportunity than acute pain.

Edward Lance Arellano Lorilla

CEO / Co-Founder

Enjoy the little things in life. For one day, you may look back and realize they were the big things. Many of life's failures are people who did not realize how close they were to success when they gave up.