Vertex Pharmaceuticals (NASDAQ:VRTX) has reported positive outcomes from three late-stage studies involving its experimental orally-administered non-opioid pain medication, VX-548, designed for the treatment of moderate-to-severe acute pain.
The company conducted pivotal phase III acute pain trials for VX-548 following bunionectomy and abdominoplasty surgeries. Both studies successfully met their primary endpoint, demonstrating that treatment with VX-548 led to a significant reduction in pain intensity over 48 hours compared to a placebo.
Despite meeting primary goals, both studies fell short of a key secondary objective, which was to establish the superiority of VX-548 over the combination of the opioid drug hydrocodone bitrate and acetaminophen (HB/APAP) in pain reduction.
Additionally, Vertex explored VX-548 in a single-arm late-stage study, administering the drug for up to 14 days across various surgical and non-surgical acute pain conditions. Data from this study revealed that approximately 83% of participants rated the drug as ‘good,’ ‘very good,’ or ‘excellent’ in managing pain.
In light of these findings, Vertex’s management plans to submit a new drug application (NDA) to the FDA for VX-548, seeking approval for a broad label in the treatment of moderate-to-severe acute pain by mid-2024.
Following the announcement, Vertex’s shares rose by 2.4% on Tuesday. Currently, opioids serve as the standard of care for acute pain treatment, despite their effectiveness, they pose significant risks of addiction and abuse. While VX-548 did not outperform opioid medications in pain management, the studies highlighted its efficacy as a potential alternative.
Over the past year, Vertex’s stock has witnessed a 38.1% increase, in contrast to the industry’s 12.3% decline.
In the previous month, Vertex disclosed positive data from a mid-stage study involving VX-548 for painful diabetic peripheral neuropathy (DPN), a neuropathic pain type associated with diabetes. The drug demonstrated a statistically significant and clinically meaningful reduction in pain intensity, prompting Vertex to advance VX-548 to pivotal development for DPN. Additionally, the company initiated a phase II study for VX-548 in patients with painful lumbosacral radiculopathy, another form of peripheral neuropathic pain caused by nerve damage.
Despite Vertex’s dominance in the cystic fibrosis (CF) market, the company has achieved success in its non-CF pipeline candidates recently. In the preceding month, the FDA approved Vertex and CRISPR Therapeutics’ (CRSP) Casgevy for sickle cell disease (SCD) treatment, making it the first gene therapy utilizing CRISPR technology. Furthermore, the FDA expanded Casgevy’s label to include the treatment of transfusion-dependent beta thalassemia (TDT) in patients aged 12 years and older earlier this month.
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