Vertex non-opioid pain drug meets main goal in late-stage trials

 Vertex Pharmaceuticals' experimental drug reduced acute, post-surgical pain without causing addiction, a major milestone in the company's decades-long efforts to bring a non-opioid pain medicine to market.

The company plans to file for U.S. approval by mid-2024 for drug, which works by blocking pain signals at its origin before they reach the brain. If approved, it could achieve annual sales of more than $5 billion, according to analysts.

When compared with a placebo, the drug was more effective in reducing the intensity of pain after 48 hours in two late-stage studies, Vertex said in a statement on Tuesday.

The treatment, however, failed to meet secondary goals of reducing pain when compared to a combination of the opioid drug hydrocodone and acetaminophen.

Shares of the drugmaker, up more than 35% in the past 12 months, fell nearly 2% to $429 in premarket trading.

Still, Wall Street analysts hailed the results as a win for Vertex and said the drug was likely to gain approval for treatment of acute pain, offering a much-needed replacement for addictive opioid painkillers that have driven a national crisis.

"Investors and the company did not expect superiority over opioid as there is a huge safety (and) addiction advantage even without that," said Wells Fargo analyst Mohit Bansal.

While Vertex's drug works by blocking pain signals at source, opioids travel through the blood and attach to receptors in the brain, making them prone to addiction and abuse.

The company said the drug, which it has named VX-548 in trials, was safe and well-tolerated in the trials.

Attempts to bring new opioid alternatives to market by drugmakers such as Eli Lilly and Regeneron Pharmaceuticals have failed in past clinical trials.

"I don't think anybody expects that this drug will replace or mean the end of opioid pain medicines, but it absolutely offers an alternative that is sorely needed," Piper Sandler analyst Christopher Raymond said ahead of data.

Nearly 645,000 people died in the United Stated from overdoses involving opioids, both prescription and illicit, from 1999 to 2021, according U.S. government data.

https://finance.yahoo.com/news/1-vertex-non-opioid-pain-115327912.html