pharmafileOctober 25, 2018
The drug’s efficacy was determined by evaluating changes from baseline after 16 weeks of treatment in pain intensity and physical function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscale alongside patient-reported outcomes assessments.
It was found that tanezumab demonstrated a "significant reduction" in pain symptoms compared to placebo, when patients were unable to find relief through other treatments, including opioids; more than half of patients taking the drug experienced a 50% or greater reduction in pain.
"The results demonstrated by tanezumab in this study are particularly meaningful, given that patients had moderate-to-severe pain and were unable to achieve adequate pain relief with other treatment options, including opioids and NSAIDs," said Ken Verburg, Tanezumab Development Team Leader at Pfizer Global Product Development. "Our goal is to be able to offer tanezumab as a potential non-opioid treatment option for these patients suffering from osteoarthritis pain."
OA affects over 27 million people in the US, and many are left without relief from ongoing, progressive, debilitating pain due to limited available treatments. If approved, tanezumab, provide the first non-opioid treatment option for OA patients, as well as those with chronic low back pain, helping to alleviate the ongoing opioid crisis in the country, where the addictive mediations killed 49,000 in 2017 alone.
"Pfizer and Lilly each have a long-standing heritage of scientific innovation in developing novel pain treatments and a shared commitment to the development of tanezumab," said Christi Shaw, senior vice president, Eli Lilly and Company and president, Lilly Bio-Medicines. "These initial results from our Phase 3 program for tanezumab are promising, and we’re eager to gain further insights as additional data report out next year."
The drugmaking pair plans to present the data to the FDA next year in support of a regulatory submission.
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