The marketing authorization application filing is based on a pivotal phase II/III trial study that included a total of 155 patients and compared Dyloject to Voltarol and placebo in the treatment of postsurgical pain.
In addition to meeting the study’s primary endpoints of total pain relief through four hours and non-inferiority to Voltarol, secondary endpoint results showed statistically significant superior pain relief over the first two hours compared to Voltarol.
Dyloject demonstrated faster onset of analgesia within 15 minutes compared to Voltarol according to pain intensity and pain relief measures, and higher proportion of patients achieving a clinically meaningful 30% decrease in pain intensity.
“This submission completes the Dyloject MAA filing and is a major milestone in our commitment to bring improved, simple and user-friendly treatment options to patients suffering from moderate-to-severe pain,” stated Douglas Hamilton, chief operating and financial officer, Javelin Pharmaceuticals.