Teva Pharmaceutical Industries Ltd., (TEVA) Wednesday said it initiated a New Drug Application or NDA submission to the U.S. Food and Drug Administration for CEP-33237 or hydrocodone bitartrate extended-release tablets. The compound intended to manage severe pain daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. CEP-33237, free with acetaminophen, is expected to have abuse-deterrent properties and thus was allowed for fast track designation.
Teva also announced positive results from a nasal Human Abuse Liability or HAL study which supports the NDA. The study found that in non-dependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone.
According to the company, overall drug liking was also significantly lower for crushed CEP-33237 compared to IR hydrocodone. In both studies, intact CEP-33237 showed similar abuse potential to placebo.
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