Purdue Pharma wins Priority Review designation for its abuse-deterrent, extended-release hydrocodone

Purdue Pharma (Stamford, CT) has been granted Priority Review status by FDA for its New Drug Application (NDA) for extended-release hydrocodone bitartarate (called, for now, Hyd). The formulation includes abuse-deterrent features intended to prevent the drug from being abused to generate a drug addict’s high by releasing all of the tablet’s hydrocodone at once. Such abuse-deterrent features were absent from the recently commercialized Zohydro product of Zogenix (San Diego), which generated alarm bells nationally and throughout the healthcare system. The concern is that drug abusers could manipulate Zohydro to obtain a high; for its part, Zogenix has set up a tight distribution system to prevent widespread abuse. FDA itself incurred extensive criticism from state governments and Congress for the Zohydro approval because of the potential for abuse; FDA approved Zohydro despite a strong negative vote from an FDA advisory panel.

Both Purdue’s Hyd and Zohydro are meant to be once-daily, extended-release products, for treating patients with chronic pain. This is in contrast to how hydrocodone is typically dispensed, in a lower dosage and combined with acetaminophen. But besides the presumed better efficacy in pain management with an extended-release formulation, the new drugs will not have the serious side effects that overuse of acetaminophen is now known to cause. Teva and Pfizer are also working on extended-release, acetaminophen-free opioid formulations.

FDA’s Priority Review requires the same scientific/medical standards as a non-priority NDA; the review process is accelerated to meet a public health need. Purdue says that the review is expected to be complete by October.

In related news, a contractor for Purdue, KBR Building Group, announced that it had been awarded a contract by the company to build a 188,000-sq.ft oral-solid dosage manufacturing facility in Durham NC. Purdue has not said publicly whether the facility is tied to the expected FDA approval of Hyd; an earlier announcement from the company noted that the facility would cost nearly $60 million, employ about 100, and be completed in 2015.