Durect and King sign long-term Remoxy excipient supply deal
Under the new deal King, which was sublicensed by Durect’s Remoxy partner Pain Therapeutics to help commercialise the drug in 2005, will pay the former a fee-based on its manufacturing costs.
The accord structures a relationship that has been in place since last year as Durect’s president and CEO, James Brown. He said that “we're pleased to have now entered into this long term arrangement with King that formalizes the details of our supply agreement.”
Brown also commended King’s presence in the pain management market and particularly its experience in the production of anti-abuse medications adding that Durect “look[s] forward to supporting King’s efforts to bring the drug to market.”
NDA resubmission in 2010
What King’s efforts will be was set out earlier this month when Pain Therapeutics revealed that the firm planned to resubmit Remoxy for US Food and Drug Administration (FDA) approval in mid-2010.
The drug Remoxy, which is an anti-abuse formulation of the opioid painkiller oxycodone that employs Durect’s Oradur controlled-release technology, was originally filed with the FDA in 2008.
However, in December the US regulator said it would need additional non-clinical data before it would approve Remoxy.
Somewhat worryingly for King, Durect and Pain Therapeutics several members of the FDA review panel voiced concerns about how the drug’s Oradur based gelatine capsule prevents abuse.
Nevertheless, resubmission is planned with King assuming sole responsibility for seeking regulatory approval for the drug.
As the developer of the Oradur technology it is likely that Durect will work with King on the data request by the FDA, although this is yet to be confirmed.
