Priority Review is given by the FDA to drugs that could make major improvements to treatment of serious conditions, compared to the current standard therapies. The designation affords candidates extra attention and resources from the FDA but it does not alter the scientific standards of quality of evidence necessary for approval.
Purdue announced this week it had filed a New Drug Application (NDA) for its hydrocodone bitartrate tablet (HYD) in April 2014 and the FDA will deliver a response in October 2014.
The once-daily extended release HYD tablet was designed with the help of a CRO to prevent its abuse by patients and recreational users. Its formulation makes it harder for users to chew the tablet or crush it for snorting or intravenous injection.
Addiction studies
The FDA requires drug developers to provide preclinical and clinical studies on the potential for addiction of certain categories of pharmaceuticals, including those that act on the central nervous system. This can include testing the medicine on volunteer recreational drug users, who give feedback on its attractiveness and ‘high’.
Purdue performed these clinical abuse liability studies, as well as manipulation and extraction research ahead of its submission to the FDA.
Hydrocodone combination products are one of the most commonly prescribed opioid analgesics in the US, and also the most widely abused. Several companies have taken steps towards incorporating anti-abuse technology including Zogenix, which announced last week it will submit a modified version of its hydrocodone drug Zohydro (not a combination product) to the FDA in October.
Purdue has previously added technology to prevent manipulation of the extended release of its opioid painkillers. The FDA approved the company’s abuse-deterrent labelling for reformulated OxyContin in April 2013 after the drug was made more difficult to crush or dissolve for snorting or injection.
The original OxyContin was withdrawn from sale and the FDA stopped approving its generics, allowing Purdue Pharma a patent on the reformulated OxyContin.