US regulators have turned down a new painkiller from the biotech Durect due to concerns over the drug’s safety.
The Food and Drug Administration (FDA) issued a complete response letter to Durect stating that the company’s regulatory filing for Posidur (bupivacaine) did not contain sufficient information about the drug’s safety.
The agency instructed Durect that additional clinical safety studies needed to be carried if the company wanted to market the drug in its proposed indication as an analgesic for patients who have undergone surgery.
Durect said it was evaluating the issues described in the letter and plans to have further discussions with the FDA.
The company’s CEO James Brown said: “In the coming months, we intend to work with the FDA to gain more clarity on the next steps that would be required to address the issues cited in the complete response letter.”
According to Reuters, the news led to a 30 per cent decline in Durect’s shares.
It is not the first setback for Durect regarding Posidur, which failed to post significantly positive results in a phase III trial in 2012.
Shortly after these results were posted, Durect reported that its development partner Hospira was returning its rights for Posidur, which covered commercialisation in the US and Canada, back to Durect.
A year earlier, Takeda, through its subsidiary Nycomed, announced it had agreed to hand back its rights for Posidur. These covered Europe.Despite these struggles and the latest complete response letter, Durect confirmed it was still looking for potential partners with regards to licensing developing and commercialisation rights for Posidur.