Purdue Pharma submits NDA for its abuse-resistant, extended-release hydrocodone product


Entry comes as FDA-healthcare provider dispute continues over Zogenix’ Zohydro version of extended-release hydrocodone

Even while Zogenix (San Diego) tussles with, among others, the state of Massachusetts over the commercialization of its controlled substance, Purdue Pharma (Stamford, CT) was being talked about as a safer version of extended-release hydrocodone for around-the-clock chronic pain. FDA had approved Zohydro last fall (countermanding the vote of its advisory panel); shortly thereafter, states and multiple healthcare organizations petitioned FDA to rescind the approval, fearing a new wave of addicts and drug abusers who might defeat the extended-release measures Zogenix took with its product. Massachusetts banned dispensing of the drug within its borders—which in turn sets up a state-federal constitutional debate; in general, once a federal agency like FDA takes an action, that action is supposed to apply uniformly across the country. A federal judge overturned Massachusetts’ ban; the governor responded with a set of restrictions on how it is to be prescribed. Nearly 30 other states would also like to see the product off the market.

Purdue has filed its New Drug Application (NDA) and, today (April 29), presented results of four clinical trials at a meeting of the American Pain Society (Tampa, FL). Generally speaking, the trials showed a pain-reduction effect, and also that abusive forms of taking the drug (such as grinding it into a powder, which has been one of the ways that another Purdue product, OxyContin, had been abused in the past) had a significantly lower “like” score among test subjects. (The Purdue papers make for interesting reading: one of the methods of testing the product was to measure its satisfaction among “recreational opioid drug users.”) The assumption is that Purdue’s abuse-deterrence features will make it safer, in a public health sense, than Zogenix’ product.

For the time being, FDA is sticking to its guns: Commissioner Margaret Hamburg wrote, on an FDA blog, that “The approval of Zohydro is not likely to significantly change overall opioid prescribing and use by patients suffering from pain;” but rather, patients using immediate-release forms of opioids will substitute the extended-release form. The abuse-deterrence features can be defeated by simply taking more of the drug, she states. She also contends that there is no scientific reason to single out Zohydro; all opioids need responsive and effective patient-management practices to prevent abuse, something that is being conducted, with greater or lesser degrees of success, by state prescription drug monitoring programs (PDMPs) and by the risk evaluation and mitigation strategies (REMS) programs that FDA has set up for opioids.

Opioid-based drugs have a long history of abuse, but public health authorities are growing increasingly alarmed by the mounting deaths from prescription drug abuse, and the societal problems caused by desperate addicts. On the flip side, pain physicians have argued that chronic pain is being undertreated, and these drugs provide a meaningful improvement in quality of life for pain sufferers. The extended-release hydrocodone issue is playing out at the same time that DEA is acting to shift hydrocodone products from Schedule III to Schedule II (thus establishing tigher controls over the product), and continues to cite pharmacies (most recently CVS pharmacies in California) for poorly managing their dispensing practices.

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