By Christy Santhosh and Sriparna Roy (Reuters) -Vertex Pharmaceuticals said on Thursday its experimental non-opioid drug met the main goal of a mid-stage study but showed little difference versus a placebo in reducing pain, sending its shares down nearly 14% in early trade. The results raised questions over whether the drug could succeed in a […]
Health
Vertex’s painkiller results match placebo in study, shares tumble
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By Christy Santhosh and Sriparna Roy
(Reuters) -Vertex Pharmaceuticals said on Thursday its experimental non-opioid drug met the main goal of a mid-stage study but showed little difference versus a placebo in reducing pain, sending its shares down nearly 14% in early trade.
The results raised questions over whether the drug could succeed in a planned late-stage study, according to some Wall Street analysts, even as the company said it would design the trial in a way to better control the placebo effect.
The study tested pain reduction in patients with a condition called lumbosacral radiculopathy, caused by a pinched nerve in the spine. It has no specific approved treatments, and is commonly treated by non-steroidal anti-inflammatory drugs, with surgery being the last resort.
Separately, the U.S. Food and Drug Administration is reviewing Vertex’s application seeking its use as a treatment for moderate-to-severe acute pain.
The drug, called suzetrigine, is expected to become a multi-billion dollar product if approved. It works by blocking pain signals at their origin before they reach the brain – unlike opioids which trigger the brain’s reward centers as they travel through the blood and then attach to the receptors in the brain.
In the mid-stage study, treatment with the drug showed a mean reduction of 2.02 points in a weekly average of daily leg pain intensity at 12 weeks, compared with the placebo group’s similar pain reduction of 1.98 points, Vertex said.
The pain reduction was statistically significant, and the trial was not designed to compare the drug’s efficacy to a placebo, Vertex said.
“Although we still believe in the vast opportunity for suzetrigine in acute pain ahead of the January 30 (FDA decision), today’s data seemingly increases the clinical risk in neuropathic pain,” said William Blair analyst Myles Minter.
The drug was generally well-tolerated in the 218-patient study with no serious events.
(Reporting by Sriparna Roy, Bhanvi Satija and Christy Santhosh in Bengaluru; Editing by Devika Syamnath)