An indication hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston on Oct. 23, 2019.
Brian Snyder | Reuters
Vertex Pharmaceuticals on Tuesday said its experimental painkiller, which is being tested as a substitute for addictive opioids, significantly decreased post-surgery pain in late-stage trials
The drug, referred to as VX-548, didn’t work higher than a preferred opioid, nonetheless.
Still, the trial results bring the biotech company one step closer to developing a drug that may provide strong pain relief without the addictive potential of opioids, which have caused a horrific epidemic within the U.S. Loads of other similar painkillers never reached the market.
Vertex said it could file for Food and Drug Administration approval of the painkiller for the treatment of moderate-to-severe acute pain by the center of this 12 months.
Acute pain will likely be attributable to injury, surgery, illness, trauma or painful medical procedures and is more likely to ease with time. Around 80 million patients are prescribed a medication for his or her moderate-to-severe acute pain every 12 months within the U.S., Vertex said in a release.
Wall Street analysts have said that the drug, which works by blocking pain signals at its origin before they reach the brain, could turn out to be a blockbuster drug if it wins approval from regulators, estimating its annual sales could exceed $1 billion.
“We’re more than happy with the results from the VX-548 pivotal program, which exhibit a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings,” Vertex CEO Dr. Reshma Kewalramani said in a release.
Shares of Vertex rose greater than 2% on Tuesday following the info release. The corporate, best known for developing drugs to treat the intense genetic disorder cystic fibrosis, has a market value of about $115 billion.
Last 12 months, the corporate’s painkiller produced positive results in a mid-stage trial in diabetes patients affected by a chronic nerve condition. The stock also saw a lift from U.S. approval of the first-ever gene-editing therapy for sickle cell disease from Vertex and its partner CRISPR Therapeutics.
Vertex said Tuesday its painkiller was more practical in reducing the intensity of pain after 48 hours in two late-stage studies on greater than 1,000 patients who had abdominoplasties, also referred to as “tummy tucks,” and roughly one other thousand in individuals who had bunion surgery. Those two procedures are commonly utilized in studies of individuals with acute pain.
The corporate’s painkiller, nonetheless, failed to fulfill the secondary goal in each trials of reducing pain compared to a mixture of the opioid drug hydrocodone, which is incessantly abused, and acetaminophen, the idea for popular pain medications like Tylenol.
Jefferies analyst Michael Yee said the drug’s failure to fulfill that goal is according to expectations and that overall, the late-stage trial results released Tuesday are positive.
VX-548 was also secure and well-tolerated within the two trials and an extra study examining the protection and tolerability of the drug in people experiencing pain from a wide range of conditions. Common unwanted side effects included nausea and constipation.