Teva Submits NDA For Abuse-Deterrent Hydrocodone Bitartrate, Reports Positive Results In Abuse Liability Study

Teva Pharmaceutical Industries has submitted a New Drug Application (NDA) to the Food and Drug Administration for hydrocodone bitartrate (CEP-33237) tablets with abuse-deterrent properties. The announcement in a press release also conveyed positive results from a Human Abuse Liability (HAL) study showing that the tablets were less likely to be abused than intranasal immediate-release (IR) hydrocodone. Teva states that the study supports its rolling NDA, which is expected to be complete by the end of 2014. Michael Hayden, M.D., Ph.D., President of Global R&D at Teva, said, “Teva understands the risk of opioid abuse is a societal challenge and one many health care professionals face in treating people living with chronic pain.”

Hydrocodone Bitartrate ER

Hydrocodone bitartrate ER is an acetaminophen-free, 12-hour formulation to manage severe pain. Formulated with Teva’s proprietary abuse deterrence technology, CEP-33237 is engineered for oral and nasal administration. Zogenix’s Zohydro is also a hydrocodone bitartrate ER formulation, approved by the FDA in 2013. That approval proved controversial as doctors, patient groups, and legislators have opposed the drug, saying that it is too strong and provides ample opportunity for abuse.

Nasal HAL Study

The nasal HAL study enrolled non-dependent, recreational opioid users and tested the potential for abuse of crushed CEP-33237 snorted intranasally vs. intranasal immediate-release (IR) hydrocodone. Teva states that the abuse potential was significantly lower for crushed intranasal CEP-33237 compared to intranasal IR hydrocodone powder. Investigators made the finding using measures of drug liking, both peak at-the-moment and peak overall.

CEP-33237 Efficacy

In another study, announced in April 2014, CEP-33237 patients with chronic low back pain showed significant improvement as measured by weekly average Worst Pain Intensity (WPI) and weekly Average Pain Intensity (API) scores. Teva intends to present the full results of that study at the World Congress on Pain in Buenos Aires.

FDA’s Anti-Abuse Actions

The FDA has acted recently to address the problem of opioid abuse. In August 2014, the federal agency informed Acura of its doubts that its Aversion hydrocodone with acetaminophen tablet was sufficiently effective at averting intranasal abuse.

In October, Douglas C. Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, also wrote in the FDA Voice, expanding upon the agency’s new prescribing requirements that went into effect for hydrocodone combination products.