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FDA Accepts New Drug Application for Extended-Release Hydrocodone Tablets With Abuse-Deterrence Technology

Company seeks approval for treatment of severe pain

The FDA has accepted for review a new drug application (NDA) for hydrocodone bitartrate extended-release (ER) tablets formulated with proprietary abuse deterrence technology (CEP-33237, Teva Pharmaceutical Industries).

CEP-33237 is an investigational, 12-hour, acetaminophen-free formulation of extended-release hydrocodone 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.

The NDA filing was supported by a clinical program that evaluated the safety, efficacy, and abuse potential of CEP-33237 in human abuse liability (HAL) studies.

Results from the phase III clinical program for CEP-33237 showed significant improvement in the treatment of patients’ chronic low back pain, as measured by both weekly average Worst Pain Intensity (WPI) scores and weekly Average Pain Intensity (API) scores.

In an oral HAL study in nondependent, recreational opioid users, the abuse potential was significantly lower for finely crushed CEP-33237 than for immediate-release (IR) hydrocodone powder, based on peak at-the-moment drug liking. Overall drug liking was also significantly lower for finely crushed CEP-33237 compared with IR hydrocodone.

An intranasal HAL study found that, in nondependent, recreational opioid users, the abuse potential for finely milled intranasal CEP-33237 was significantly lower, based on peak at-the-moment drug liking, than for intranasal IR hydrocodone powder and finely milled intranasal hydrocodone bitartrate extended-release capsules [C-II] (Zohydro ER, Zogenix Inc.), as commercially available at the time the study was conducted. Overall drug liking was also significantly lower for finely crushed CEP-33237 compared with IR hydrocodone and Zohydro ER.

CEP-33237 demonstrated a safety profile that was consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence, and dizziness.

Chronic pain is defined as persistent pain that is not amenable to treatments based on specific remedies or to routine methods of pain control. A report from the Institute of Medicine estimated that chronic pain affects millions of American adults, including people who reported having severe pain, moderate pain, joint pain, arthritis, or functional limitation.

Source: Teva Pharmaceutical Industries; February 25, 2015.

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