The Phase III trial results showed significant improvement in the treatment of chronic low back pain.
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The results 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. CEP-33237 is a hydrocodone bitartrate acetaminophen-free formulation 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. The drug had a safety profile consistent with the known safety profile of hydrocodone and other opioid analgesic therapies.
“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 Teva Global R&D president and Chief Scientific Officer Dr. Michael Hayden.
Teva plans to submit a New Drug Application (NDA) for CEP-33237 to the US Food and Drug Administration (FDA) by the end of 2014.