JERUSALEM - Teva Pharmaceutical Industries on Wednesday announced the initiation of a rolling new drug application submission to the 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 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 hydrocodone.
“Teva understands the risk of opioid abuse is a societal challenge and one many healthcare professionals face in treating people living with chronic pain,” said Michael Hayden, president of global R&D and chief scientific officer at Teva. “While the science of abuse deterrence is rapidly evolving, we are pleased with the results of our HAL studies and the comprehensive clinical program that supports the NDA for CEP-33237.”
"Teva understands the risk of opioid abuse is a societal challenge and one many healthcare professionals face in treating people living with chronic pain.”
Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal.
In the intranasal HAL study, abuse potential was significantly lower for crushed intranasal CEP-33237 (45 mg) than for intranasal IR hydrocodone powder (45 mg) based on peak at-the-moment drug liking and peak overall drug liking.
In the oral HAL study, abuse potential was significantly lower for crushed CEP-33237 (45 mg) powder than for IR hydrocodone (45 mg) based on peak at-the-moment drug liking. 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.
“The comprehensive clinical program supporting CEP-33237 is an example of Teva’s long-term commitment to advancing responsible pain care,” said Richard Malamut, VP global clinical development and therapeutic area head of pain at Teva. “While no product or technology can completely eliminate abuse, having both positive oral and nasal HAL data speaks to the potential of CEP-33237 as a chronic pain treatment option with abuse deterrence properties.”
Topline results from the CEP-33237 pivotal Phase III study announced on April 30, 2014 showed significant improvement in the treatment of patients’ chronic low back pain as measured by both weekly Average Worst Pain Intensity and weekly Average Pain Intensity scores. The full results from the Phase III trial will be presented at the 15th World Congress on Pain hosted by The International Association for the Study of Pain in Buenos Aires, October 6 to11.
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 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included: nausea, constipation, vomiting, headache, somnolence and dizziness.