Vertex non-opioid painkiller shows positive results in critical late-stage trial on acute pain

An indication hangs in entrance of the world headquarters of Vertex Pharmaceuticals in Boston on Oct. 23, 2019.

Brian Snyder | Reuters

Vertex Pharmaceuticals on Tuesday stated its experimental painkiller, which is being examined as an alternative to addictive opioids, considerably decreased post-surgery pain in late-stage trials

The drug, generally known as VX-548, didn’t work higher than a well-liked opioid, nonetheless.

Still, the trial results carry the biotech firm one step nearer to growing a drug that may present sturdy pain aid with out the addictive potential of opioids, which have induced a horrific epidemic in the U.S. Plenty of different comparable painkillers never reached the market.

Vertex stated it might file for Food and Drug Administration approval of the painkiller for the therapy of moderate-to-severe acute pain by the center of this yr.

Acute pain is normally attributable to harm, surgical procedure, sickness, trauma or painful medical procedures and is more likely to ease with time. Around 80 million sufferers are prescribed a medication for his or her moderate-to-severe acute pain yearly in the U.S., Vertex stated in a launch.

Wall Street analysts have stated that the drug, which works by blocking pain alerts at its origin earlier than they attain the mind, may turn into a blockbuster drug if it wins approval from regulators, estimating its annual gross sales may exceed $1 billion.

“We are more than happy with the results from the VX-548 pivotal program, which display a compelling and constant mixture of efficacy and security throughout a number of acute pain situations and settings,” Vertex CEO Dr. Reshma Kewalramani stated in a launch.

Shares of Vertex rose greater than 2% on Tuesday following the information launch. The firm, finest recognized for growing medication to deal with the intense genetic dysfunction cystic fibrosis, has a market worth of about $115 billion.

Last yr, the corporate’s painkiller produced positive results in a mid-stage trial in diabetes sufferers affected by a power nerve situation. The inventory additionally noticed a lift from U.S. approval of the first-ever gene-editing remedy for sickle cell illness from Vertex and its accomplice CRISPR Therapeutics.

Vertex stated Tuesday its painkiller was simpler in lowering the depth of pain after 48 hours in two late-stage research on greater than 1,000 sufferers who had abdominoplasties, also referred to as “tummy tucks,” and roughly one other thousand in individuals who had bunion surgical procedure. Those two procedures are generally used in research of individuals with acute pain.

The firm’s painkiller, nonetheless, failed to fulfill the secondary purpose in each trials of lowering pain when in comparison with a mix of the opioid drug hydrocodone, which is often abused, and acetaminophen, the premise for in style pain drugs like Tylenol.

Jefferies analyst Michael Yee stated the drug’s failure to fulfill that purpose is in line with expectations and that total, the late-stage trial results launched Tuesday are positive.

VX-548 was additionally secure and well-tolerated in the 2 trials and an extra examine analyzing the security and tolerability of the drug in folks experiencing pain from quite a lot of situations. Common unwanted effects included nausea and constipation.

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