Vertex to move non-opioid painkiller into late-stage tests after FDA agreement

Vertex Pharmaceuticals said Friday it will advance an experimental drug for pain into late-stage testing following discussions with the US Food and Drug Administration on the trials’ design. The company plans to start two Phase 3 studies in the fourth quarter of the year.

In March, Vertex reported positive results from two phase 2 trials of the drug, dubbed VX-548, in people who had stomach or bunion surgery. The drug is a non-opioid painkiller, potentially offering a non-addictive option as the opioid crisis continues to affect communities.

Vertex also plans to advance research of the drug as a treatment for neuropathic pain. The company said it will launch a Phase 2 trial at the end of the year.

Vertex’s pipeline has been the focus of investors who have pressed the company on how it plans to grow beyond its successful cystic fibrosis business. With the positive results reported earlier this year, VX-548 is one potential candidate Vertex has pointed to in response.

While the company has hit some research setbacks, it has hopes for other drugs in its pipeline, too. Vertex currently has a drug for a type of kidney disease in phase 2/3 clinical trials, and is advancing a CRISPR gene editing treatment for sickle cell and beta thalassemia. It plans to submit applications for regulatory approval by the end of this year.

For VX-548, the planned pivotal program in acute pain will consist of two Phase 3 trials — both designed to be randomized and placebo-controlled — and one single-arm study to assess drug’s safety and effectiveness for other types of pain.

The phase 2 study in neuropathic pain will be randomized, active-controlled and enroll patients with diabetic peripheral neuropathy.

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