CEP-33237 demonstrated a safety profile in this study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Reported adverse events occurring five percent more often in hydrocodone-treated patients versus placebo included gastrointestinal (e.g. constipation) and central nervous system (e.g. somnolence) events. The potential abuse-deterrent properties of CEP-33237 were confirmed in previously conducted in vitro and pharmacokinetic studies and a human abuse liability study. Teva’s proprietary technology with potential abuse-deterrent properties is designed with the intent to reduce the abuse liability of opioid products. CEP-33237 has been formulated in this technology platform and has been evaluated to measure vulnerability against physical manipulations, chemical extractions and multi-step chemical extractions, as well as the “likeability” of a manipulated tablet in a clinical abuse potential study.“With more than 100 million Americans living with the distress of chronic pain, patients, clinicians and society as a whole have a real need for effective opioid therapies,” said Michael Hayden, Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “CEP-33237 is an example of Teva’s commitment to responding to the healthcare needs of patients and society alike through the development of treatment options that support responsible pain management.” Teva expects to submit a New Drug Application (NDA) for CEP-33237 to the U.S. Food and Drug Administration (FDA) by the end of 2014. These are top-line results from this trial and it is intended that additional data from this trial will be published in scientific literature and also presented at forthcoming medical congresses. About Teva Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
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