Non opioid green bread Drug Flunks proof of concept proof, ending the plans for a pivotal study

A green pharmaceutical drug considered as a successor to a non-opioid pill which won historical approval from the FDA earlier this year failed in a mid-term clinical trial, which has returned to the strategy of the company for the construction of a diversification medication franchise to diversify its sources of income.

Based on the results of clinical trials, Vertex will not advance the medication, VX-993, with phase 3 tests in monotherapy to treat acute pain, the company announced after the closing of the market on Monday.

Boston’s summit approach to the summit pain focuses on blocking sodium channels, the peripheral nervous system routes that transmit pain signals. By blocking these signals on the outskirts, this approach is intended to avoid the risk of dependence posed by opioid drugs which reach targets in the central nervous system.

VX-993 is designed to block a sodium channel called Nav1.8, the same target as Journavx, the analgesic pill twice a day of Green approved in January. With VX-993, the summit developed oral formulations and administered intravenously. Version IV had offered the higher dosage potential to provide an alternative to Opioid IV drugs. The company also hoped that the VX-993 could be part of a future combination of therapies alongside a medication that goes after another sodium channel, Nav1.7.

The results reported on Monday come from a placebo-controlled dose study which assessed an oral version of VX-993 in patients with acute pain after golionctomy surgery. The 367 study participants were evaluated according to a scale used to measure the intensity of the pain. The results have shown a digital improvement in scores for medium and high doses, but not enough to be statistically significant.

“This study of proof of concept was propelled to test whether the VX-993 would lead to higher clinical efficiency than that previously demonstrated with the Nav1.8 route,” said Carmen Bozic, executive vice-president, development of global drugs and medicine, and chief of Vertex, in a prepared press release. “On the basis of these results, as well as all of the preclinical data and the results of our clinical studies in previous Golionctomy, the VX-993 should not be greater than our existing Nav1.8 inhibitors and therefore we will not progress them in the form of monotherapy in acute pain.”

The results of phase 2 for VX-993 were reported at the same time as the Vertex release of the financial results of the second quarter of 2025. In this report, Vertex said that its discussions with the FDA indicated that the regulator did not see a path to widen the label of Jouravx to peripheral neuropathy today. Consequently, the summit will not start a phase 3 test of the pill in the lombo-sacular radiculopathy, a condition of pain in the lower back also known as the sciatica.

The company has declared that it would favor the development of journals in diabetic peripheral neuropathy; A phase 2 study is underway. A phase 2 test separated from VX-993 is registered with patients with diabetic peripheral neuropathy. Vertex plans to finish registration for the two mid-term tests by the end of 2026. The plan is to advance daily to a pivot test in diabetic peripheral neuropathy. Vertex said that he would continue to work with the FDA to extend the indication of diabetic peripheral neuropathy over time to include other neuropathic pain conditions and assess the potential means of securing a large label in this type of pain.

Since Vertex launched Journavx in early March, the company reported more than 110,000 written prescriptions and filled for the product, in the hospital and retail, for different types of acute pain. The company also said that nearly 150 million people had covered access to the product, which represents almost half of us, covered in lives. Vertex said $ 13.3 million in daily income for the first half of 2025.

Photo: David L. Ryan / The Boston Globe, via Getty Images