ProStrakan reports positive phase III data for Rapinyl

ProStrakan has announced that Endo Pharmaceuticals has reported positive results for its phase III US trial of Rapinyl.

Rapinyl is a fast-dissolving tablet for sub-lingual administration of fentanyl indicated for use in the treatment of breakthrough cancer pain.

Data from an interim analysis has demonstrated that Rapinyl meets its primary endpoint – the Sum of Pain Intensity Difference from baseline to 30 minutes.

In addition, all secondary endpoints were met with statistically significant separation on mean pain intensity seen after only ten minutes from dosing.

Dr Wilson Totten, chief executive of ProStrakan, welcomed the release of the analysis and expressed his delight in seeing positive results.

“We view the results as further evidence of the efficacy of this important product and validation of our belief in the clinical and commercial value of Rapinyl.”

Endo is currently waiting on European approval for the drug, with it currently being reviewed by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

A positive decision will be sufficient to gain EU approval and ProStrakan has stated its expectation to see the approval process complete in 2008.

Last year, ProStrakan announced that it was to establish a sales force in the US through a newly-signed strategic agreement with NovaQuest, the partnering group of Quintiles Transnational.