Tanezumab for Chronic Low Back Pain Relief: Phase 3 study

“Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.” Link

“Tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics.” Link

Comments from Pfizer regarding the study of Tanezumab for chronic low back pain, July 21 2020.

Pfizer and Lilly made the decision to prioritize tanezumab as a potential treatment for osteoarthritis, based on an assessment of the totality of SC tanezumab data and an initial discussion with the FDA.

At this time, regulatory submissions are not planned for tanezumab in patients with moderate-to-severe chronic low back pain (CLBP), but we recognize the significant patient needs and intend to maintain an open dialogue with regulatory authorities on potential future regulatory pathways for tanezumab. Additional data analyses, and potentially further clinical study, may be required to more fully characterize tanezumab in CLBP patients.

Additional information:

Alliance announced in early March that the U.S. FDA accepted the regulatory submission for Tanezumab, a potential first-in-class treatment for patients with chronic pain due to moderate-to-severe osteoarthritis.


Markman, John D.a,*; Bolash, Robert B.b; McAlindon, Timothy E.c; Kivitz, Alan J.d; Pombo-Suarez, Manuele; Ohtori, Seijif; Roemer, Frank W.g,h; Li, David J.i; Viktrup, Larsj; Bramson, Candacek; West, Christine R.k; Verburg, Kenneth M.k Tanezumab for chronic low back pain, PAIN: June 25, 2020 – Volume Articles in Press – Issue – doi: 10.1097/j.pain.0000000000001928

FDA Approved Emgality Offers New Hope For Migraine Prevention

PainRelief.com Interview with:
Gudarz Davar, M.D., Vice President
Neuroscience Platform Leader
Eli Lilly and Company

PainRelief.com: What is the background for this announcement?  How big a problem is migraine in the US?  Who is primarily affected? 

Response: Migraine is a disabling, neurologic disease that affects more than 30 million American adults. According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the U.S. is estimated to be as high as $56 billion annually. People with migraine can miss out on significant moments in their lives—birthdays and anniversaries—and there remains an unmet need for treatment options that can help patients achieve significant reductions in the overall frequency of migraine attacks.

Emgality (galcanezumab-gnlm) was approved by the FDA on Thursday, September 27, for the preventive treatment of migraine in adults. Emgality is a humanized monoclonal antibody indicated for the preventive treatment of migraine in adults that binds to CGRP ligand and blocks its binding to the receptor, which is believed to play a role in migraine. It is offered as a self-administered, once-monthly subcutaneous injection. Emgality offers new hope to people living with migraine as one of the first medicines developed specifically for the prevention of migraine.

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