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news.The US Food and Drug Administration (FDA) has accepted for review the new drug application (NDA) for Teva Pharmaceutical's hydrocodone bitartrate extended-release (ER) tablets formulated with its abuse deterrence technology (CEP-33237) for pain management.
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Teva’s CEP-33237 is an investigational, 12-hour, acetaminophen-free, formulation of extended-release hydrocodone designed to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The NDA was based on data from a clinical program that evaluated the safety and efficacy of CEP-33237, as well as the abuse potential of CEP-33237 through the oral and intranasal routes of abuse in Human Abuse Liability (HAL) trials.
Teva president of Global R&D and chief scientific officer Michael Hayden said: "With positive results from Human Abuse Liability studies in the two most common routes of hydrocodone abuse, CEP-33237 with potential abuse deterrence properties, represents a positive step towards responsible pain management."
The 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) and weekly Average Pain Intensity (API) scores.
Teva vice-president of Global Clinical Development and Therapeutic Area head of Pain Richard Malamut said: "The impact of living with chronic pain can be devastating, affecting many aspects of daily life.
"If approved, CEP-33237 will provide an important treatment option for people living with chronic pain and healthcare professionals who care for them."
In the oral HAL trial carried out in nondependent, recreational opioid users, 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.
The intranasal HAL trial showed that in nondependent, recreational opioid users, 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 Zohydro ER capsules [C-II] as commercially available at the time the study was conducted.