A sign hangs in front of Vertex Pharmaceuticals' global headquarters in Boston on Oct. 23, 2019.
Brian Snyder | Reuters
Vertex Pharmaceuticals on Tuesday said its experimental painkiller, which is being tested as an alternative to addictive opioids, significantly decreased postsurgical pain in late-stage trials.
However, the drug, known as VX-548, worked no better than a popular opioid.
Still, the trial results bring the biotech company one step closer to developing a drug that can provide strong pain relief without the addictive potential of opioids, which have caused a terrible epidemic in the US. Many other similar painkillers never made it to the market.
Vertex said it would ask the Food and Drug Administration to approve the painkiller for the treatment of moderate to severe acute pain by the middle of this year.
Acute pain is usually caused by injury, surgery, illness, trauma, or painful medical procedures and is likely to decrease over time. About 80 million patients are prescribed a medication for moderate to severe acute pain each year in the U.S., Vertex said in a statement.
Wall Street analysts have said the drug, which works by blocking pain signals at their source before they reach the brain, could become a blockbuster drug if it wins regulatory approval, estimating its annual sales could exceed one billion dollars.
“We are very pleased with the results of the pivotal VX-548 program, which demonstrates a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings,” Dr. Reshma Kewalramani, CEO of Vertex, said in a statement.
Vertex shares rose more than 2% on Tuesday following the release of the data. The company, best known for developing drugs to treat the serious genetic disorder cystic fibrosis, has a market value of about $115 billion.
Last year, the company's painkiller produced positive results in a mid-stage trial in diabetic patients with a chronic nerve condition. The stock also saw a boost from the U.S. approval of Vertex and its partner's first gene-editing therapy for sickle cell anemia. CRISPR therapeutics.
Vertex said Tuesday that its painkiller was most effective at reducing pain intensity after 48 hours in two late-stage studies in more than 1,000 patients who underwent tummy tucks, also known as “abdominoplasties,” and about a thousand others in people who underwent bunion surgery. . Those two procedures are commonly used in studies of people with acute pain.
However, the company's painkiller failed to meet the secondary goal in both trials of reducing pain compared to a combination of the frequently abused opioid drug hydrocodone and acetaminophen, the base of popular painkillers such as Tylenol.
Jefferies analyst Michael Yee said the drug's failure to meet that goal is in line with expectations and that the late-stage trial results released Tuesday are generally positive.
VX-548 was also safe and well tolerated in both trials and in an additional study that examined the drug's safety and tolerability in people experiencing pain due to a variety of conditions. Common side effects included nausea and constipation.
