TLC Announces Topline Results for TLC590 Phase II Trial for Postsurgical Pain Management following BunionectomyDownload
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, today announced topline results from the TLC590 Phase II clinical trial, a randomized, double-blind, placebo- and comparator- controlled study of TLC590 in patients following bunionectomy. Results show that TLC590 demonstrated greater reductions in pain than both placebo and bupivacaine through 168 hours.
TLC590 is a non-opioid, proprietary BioSeizer® sustained release formulation of ropivacaine. The trial compared TLC590 (228mg) with normal saline placebo and the current standard of care for postsurgical pain relief, bupivacaine (50mg), in 150 patients randomized at the ratio of 1:1:1. The primary outcome measure was comparison of pain relief between TLC590, placebo, and bupivacaine in area under the curve (AUC) on the numerical pain rating scale (NPRS).
Key findings from the trial are as follows:
“We continue to be excited about TLC590 as we observed a promising trend in this small patient population, similar to what we saw in our Phase I/II clinical trial in patients following hernia repair surgery, and we believe that in an expanded patient population, this drug will demonstrate significant clinical benefits beyond 24 hours in our upcoming pivotal trials,” said TLC President George Yeh. “We will continue to analyze the data and work closely with regulatory bodies to efficiently bring TLC590 to market. TLC is committed to presenting a fast onset, long-lasting, single-dose non-opioid treatment that can potentially reduce the need for opioids while helping patients cope with the pain experienced after surgery.”
Details of TLC590’s clinical trials can be found on ClinicalTrials.gov.