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FDA grants fast track designation for tanezumab in treatment of chronic pain
The FDA has granted fast track designation for Pfizer and Eli Lilly’s tanezumab for the treatment of chronic pain in patients with osteoarthritis and for chronic low back pain, according to a company press release.
“If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications,” Ken Verburg, chief development officer of Neuroscience & Pain at Pfizer Global Product Development, said in the release. “We believe it would represent an important medical advance in the treatment of debilitating osteoarthritis and chronic low back pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications.”
Tanezumab is the first nerve growth factor inhibitor to receive a fast track designation. Tanezumab’s phase 3 program includes six studies of about 7,000 patients with osteoarthritis, chronic low back pain or cancer pain who did not have adequate pain relief from approved therapies. The results of these studies will be reported in 2018, according to the release. The studies each examine subcutaneous administration of tanezumab once every 8 weeks for periods ranging between 16 weeks and 56 weeks. There is also a 24-week safety follow-up period.
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