Luye Pharma has completed patient enrolment in a Phase II clinical trial of its LY03014 drug to treat acute postoperative pain and breakthrough cancer pain in China.
The placebo and positive parallel-controlled, multicentre, double-blind, randomised study is intended to assess the preliminary safety and efficacy of the investigational drug as an analgesic.
Patients with moderate-to-severe pain after abdominal surgery are enrolled in the study.
Improvements in pain threshold and tolerance were observed in subjects administered with a single intravenous infusion of LY03014 in a Phase I study. It also showed a good overall safety profile.
LY03014 is a small-molecule G protein-biased mu-opioid receptor (MOR) agonist.
It completely separates the β-arrestin-2, G protein pathways and reduces the risk of opioid-induced respiratory depression (OIRD), a common risk factor in patients leading to death.
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Luye Pharma is planning to expand its CNS drug portfolio in the Chinese market mainly focusing on developing therapeutics for pain management.
Rykindo, Ruoxinlin, Rivastigmine Transdermal Patches, Seroquel and its extended-release tablets are some of the CNS drugs available in China.
In addition to LY03014, which is designated as a Class 1 Chemical Drug in China, Luye is developing LY03010, LY03003 and LY03015.
More than 300 million patients receive surgeries every year globally and over 80% of them suffer from postoperative pain.