Abuse-deterrent single-entity hydrocodone products are edging closer to market.
Purdue Pharma LP has announced that the US Food and Drug Administration (FD) has granted Priority Review designation for its once-daily single-entity hydrocodone bitartrate tablet, an investigational pain medication formulated to make the product more difficult to misuse or abuse though chewing, snorting, and intravenous injection.
And Zogenix Inc has provided an update on development of its 2 abuse-deterrent formulations of Zohydro ER (hydrocodone bitartrate), an abuse-deterrent version of the capsule already approved, and a new abuse-deterrent tablet version. Zohydro ER was approved in October 2013 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Commenting on the priority designation status for its drug application, Mark Timney, president and CEO of Purdue Pharma, said it was "another milestone in our effort to offer patients and health professionals a portfolio of pain medications with abuse-deterrent technology."
Priority Review is granted to drug applications that, if approved, would substantially improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications, although the designation doesn't alter the quality of evidence necessary for approval.
Purdue announced filing the New Drug Application (NDA) for its hydrocodone bitartrate tablet this past April. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for October of this year.
At the American Pain Society 33rd Annual Scientific Meeting in May, data were reported by Purdue showing this abuse-deterrent formulation of hydrocodone provided safe and long-lasting pain relief in a variety of patients with chronic pain, including those who had used opioids before and those who were opioid-naive.
Most Abused
Hydrocodone combination products are among the most commonly prescribed opioid analgesics in the United States, but they're also the most widely abused, according to the Substance Abuse and Mental Health Services Administration.
Zogenix has come under great fire since approval of its single-entity hydrocodone, which was approved even though the FDA's own advisory panel recommended against approval in an 11 to 2 vote. Since then, call for reversal of this approval has come from 29 state attorneys general and a coalition of groups calling itself "FedUp!: A Coalition to End the Opioid Epidemic." Bills have been introduced in both the House and the Senate to overturn approval of this drug.
A ban on prescribing the drug in the state of Massachusetts in March as part of a strategy to protect against abuse and diversion has now twice been overturned, with the most recent decision by the US District Court in Massachusetts upholding its prior decision that imposing regulations to restrict access to the drug violates constitutional law.
"This ruling upholds the important principle that a state cannot take action that could reverse the approval of a prescription drug product by the United States Food and Drug Administration," Zogenix CEO Roger Hawley said in a statement dated July 9.
Meanwhile, following a recent meeting with the FDA, Zogenix Inc reported that it expects to file a supplemental NDA by October for a next-generation formulation of Zohydro ER extended-release capsules designed to make it more difficult to abuse by injection or nasal administration. If approved, this new formulation could be available to prescribers in early 2015, said the company in a press release issued July 2.
A company goal is to further amend the labeling for this product next year to include abuse deterrence claims consistent with the FDA's draft Guidance for Industry, Abuse-Deterrent Opioids—Evaluation and Labeling, the company notes.
Zohydro ER provides extended-release hydrocodone for around-the clock management of severe chronic pain. It's a potential solution for those who may be at risk for liver damage due to overexposure of acetaminophen, which can be fatal or require a liver transplant, the company statement notes.
Zogenix also announced selection of the final tablet formulation of Zohydro ER for clinical development in its collaboration with Altus Formulation. The formulation incorporates features to maintain the extended-release property of the medication when crushed or chewed, reducing abuse potential through oral ingestion. Other features address abuse by injection or nasal administration.
The tablet formulation is designed to have the same hydrocodone release profile as the currently approved capsule formulation of Zohydro ER when used as intended, greatly simplifying its development program, said the company. Zogenix is targeting an NDA submission for this tablet formulation during the first half of 2016.
"We believe we have 2 strong technology options to deter misuse and abuse without affecting the established safety and efficacy profile of Zohydro ER, and look forward to submitting our data to the FDA with the goal of bringing these new options to patients," said Stephen Farr, PhD, president of Zogenix, in the release.
According to Zogenix, the company has taken extraordinary steps to support the appropriate use of Zohydro ER through a voluntary set of educational tools and safeguards to augment the FDA industry mandated class-wide risk evaluation mitigation strategy for extended-release opioids. For example, it provides patients with free locking pill bottle caps and discounts for safe-storage units to deter others from gaining access to their medications.
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