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|October 08, 2014 8:01 a.m.|
|Teva Announces Initiation of New Drug Application and Positive Results from Second Human Abuse Liability Study for CEP-33237 (Hydrocodone Bitartrate) Extended-Release Tablets|
Comprehensive clinical development program, including nasal and oral HAL studies,support NDA submission for investigational pain medication formulated with Teva’s proprietary abuse deterrence technology
Teva also announced positive results from a nasal Human Abuse Liability (HAL) 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.
“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,” said
Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal.
“The comprehensive clinical program supporting CEP-33237 is an example of Teva’s long-term commitment to advancing responsible pain care,” said
Topline results from the CEP-33237 pivotal Phase III study announced on
CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in five percent or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included: nausea, constipation, vomiting, headache, somnolence and dizziness.
About Chronic Pain
Chronic pain is persistent pain that is not amenable to treatments based upon specific remedies or to the routine methods of pain control. An
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