Date: 2014-10-08
Type of information: Results
phase: 3
Announcement: results
Company: Teva Pharmaceutical Industries (Israel)
Product: CEP-33237 (Hydrocodone Bitartrate) Extended-Release Tablets
Action mechanism:
Disease: chronic pain
Therapeutic area: CNS diseases
Country:
Trial details:
Latest
news: * On October 8, 2014, Teva Pharmaceutical Industries 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 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 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 (P=0.004 for both measures). • 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 (P<0.001). 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.
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 (WPI) and weekly Average Pain Intensity (API) 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 (IASP) in Buenos Aires , October 6-11 .
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.
