Durect Says Pain Drug Meets 1 Of 2 Study Goals
From Associated Press (June 16, 2010)
CUPERTINO, Calif. -- Drug developer Durect Corp. said Wednesday its post-surgery pain drug Posidur met only one of two main goals in a midstage clinical trial in Europe.
The Phase IIb trial compared Posidur with a placebo and a commercially available injectable anesthetic to treat pain following hysterectomies. All patients in the trial received a daily dose of acetaminophen as well and had access to "rescue" opoid pain drugs if needed.
Durect said the study showed Posidur worked just as well as the other pain drug and the placebo at reducing the intensity of pain during the first three days after surgery. However, Posidur was not better at reducing patients "use of "rescue" opioid pain drugs over that period.
Durect noted that the amount of time that patients in all treatment groups took a meaningful amount of opioids was shorter than had been expected.
The company said there were no indications of systemic safety issues during the trial.
Posidur is designed to be a long-acting local anesthetic that is used during surgery to reduce pain following the surgery for up to 72 hours.
The study took place in Europe and was run by Nycomed, a Swiss drugmaker that holds the European Union rights to Posidur. The placebo drug was administered using Durect's Saber injectable drug delivery system. Durect said 115 women participated in the study.
Nycomed licensed the rights to Posidur in the European Union and other countries in November 2006. If the drug is approved in the EU, Durect could get up to $181 million from Nycomed in development, regulatory and sales milestone payments, in addition to royalties. Durect will also supply the drug to Nycomed for commercial sale.
Durect said it is currently enrolling patients in its U.S. Phase III study of Posidur and said Nycomed continues to enroll in a Phase IIb study in Europe in shoulder surgery.
Durect licensed the U.S. and Canadian rights to Posidur to Hospira Inc. earlier this month. Durect will get $27.5 million upfront as part of that deal, and up to $185 million in milestone payments in addition to royalties. Durect and Hospira will share the remaining development costs for Posidur in those two countries.
Durect shares closed earlier down 6 cents at $2.82.
Posted: June 2010