Despite Vertex Pharmaceuticals Inc.’s mostly positive phase III study results of a non-opioid for treating moderate to severe acute pain, the data for a key secondary endpoint show VX-548 is not as effective as Vicodin (hydrocodone, Abbvie Inc.). Neither of two randomized, double-blind, placebo-controlled, pivotal studies, one treating patients after abdominoplasty surgery and one after bunionectomy surgery, met the key secondary endpoint of VX-548 being superior to hydrocodone bitartrate/acetaminophen in patients’ pain levels.
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All treatment groups in Vertex Pharmaceuticals Inc.’s phase II study of the non-opioid VX-548 showed meaningful reductions in pain from baseline in treating diabetic peripheral neuropathy (DPN), pointing the company toward pivotal phase III studies and prompting analysts to applaud enthusiastically.
Shares of Vertex Pharmaceuticals Inc. (VRTX) are progressing more than 9 percent on Wednesday morning trade after reporting positive results for its phase 2 study of VX-548 for the painful diabetic peripheral neuropathy.
1. In this randomized controlled trial, the elective NaV1.8 inhibitor VX-548 reduced acute pain over 48 hours following abdominoplasty and bunionectomy. 2. The main adverse events associated with VX-548 use were headaches and constipation. Evidence Rating Level: 1 (Excellent) Study Rundown: Acute pain, especially following traumas and surgical procedures, remains an area of unmet medical