Results from the 165-patient trial demonstrated that nalbuphine ER positively reduced pain intensity in a dose-dependent manner over the 12-hour study period.
Positive results were also observed in longer time to ingestion of rescue medication and the proportion of patients requiring rescue analgesic therapy during the 12-hour study period for both the low and high nalbuphine ER doses when compared to placebo.
Finally, the percent of patients experiencing at least a 50% reduction in pain intensity during the 12-hour study period was higher for the low and high nalbuphine dose groups compared to placebo. No unusual side effects were reported during the 12-hour dosing interval.
The company expects that nalbuphine ER, if approved, will compete in the moderate to moderately severe pain space with drugs such as Tramadol.
“Clearly, we need to confirm the findings from this phase IIa study in different pain models, and we are evaluating whether to develop this drug for our own portfolio or to seek a partner for further development and commercialization,” said Jennifer Good, president and COO of Penwest.