Teva initiates rolling NDA at FDA for CEP-33237 for Severe Pain.
Teva Pharmaceutical Industries Ltd., announced the initiation of a rolling New Drug Application (NDA) submission to the FDA 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 (HAL) study which supports the NDA. The nasal HAL study found that in non-dependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release (IR) hydrocodone.
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