Teva Initiates NDA for Abuse-Deterrent HydrocodoneBy
Teva Pharmaceutical Industries Ltd., has initiated a rolling new drug application (NDA) submission to the US Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva's proprietary technology providing potential abuse-deterrent properties (CEP-33237) as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. CEP-33237 is an investigational, 12-hour, acetaminophen-free, formulation of extended-release (ER) 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.
Teva also announced positive results from a nasal human abuse liability study, which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release (IR) hydrocodone.
Source: Teva Pharmaceutical Industries