Vertex's Experimental Pain Drug Meets Phase 3 Primary Goal

(RTTNews) - Vertex Pharmaceuticals (VRTX) announced on Tuesday that its experimental pain drug, which potentially can be used instead of opioids, met the primary goal of the phase 3 trial.

Under the study, Vertex enrolled more than 1,100 people who had undergone abdominoplasty and bunionectomy surgeries and were given 100 milligrams of the drug at first, and later by 50 milligrams of doses every 12 hours until 36 hours of the first dose.

The pain drug dubbed VX-548, was more effective than a placebo in relieving pain after two surgeries - abdominoplasty and bunionectomy, the company stated. In another smaller phase 3 study, the painkiller drug was found to be safe and efficient in relieving pain.

"The results, combined with those from previous trials, suggest that VX-548 has an unprecedented and compelling profile as an option for people who have acute pain," Vertex's research chief, Dr. David Altshuler said.

The chief further explained that VX-548 works by blocking pain in the peripheral nervous system rather than acting in the brain, which makes it more effective in reducing the intensity of pain even after 48 hours.

However, the drug failed to meet its secondary goal of relieving pain when compared to a combination of opioid drugs that make up Vicodin- hydrocodone and acetaminophen.

The drug manufacturer stated that its experimental drug showed lesser occurrence of side effects like nausea, headache, constipation and dizziness, compared to other drugs.

Vertex plans to seek approval from the U.S. Food and Drug Administration by mid-2024 and if approved, would garner more than $5 million in annual sales, according to analysts.