ProStrakan: Administrative details delay Sancso action date

ProStrakan has announced regulators have opted to delay the action date for Sancuso for administrative, rather than technical reasons.

The innovative patent-protected granisetron transdermal patch is being developed as a treatment for chemotherapy-induced nausea and vomiting.

ProStrakan reports the US Food and Drug Administration has given notification the action date to Friday 18th July.

“As previously stated, ProStrakan remains confident of gaining US approval for Sancuso,” the company said.

It added that it has begun manufacturing initial stocks of the compound in support of the planned launch of the drug during the second half of this year.

In August 2007, ProStrakan signed an exclusive distribution agreement for Sancuso with LG Life Sciences.

Under the terms of the deal, LG Life Sciences agreed to pay initial and landmark payments to ProStrakan of up to $6 million (three million pounds), upon the attainment of specified regulatory milestones and revenue targets.

A month prior to this agreement, ProStrakan filed a marketing authorisation application for Sancuso in the European Union.

This application was based on the positive results of a phase III clinical programme conducted the year before in patients undergoing chemotherapy.