Drug manufacturers Pfizer and Eli Lily announced that the FDA has granted Fast Track designation to tanezumab, a non-opioid biologic currently in Phase 3 development for the treatment of chronic low-back pain and osteoarthritis.
Tanezumab is a special antibody that selectively targets, binds to, and inhibits nerve growth factor, which is central to the stimulation of pain. Fast Track designation is reserved for drugs that treat unmet medical needs, and as the opioid epidemic continues to cause serious harm and financial loss, the need for strong, non-opioid pain relief is great.
With Fast Track drugs, the FDA increases communication with drug developers and reviews portions of the New Drug Application (NDA) ahead of submission of the completed application, which can significantly help manufacturers in improving their NDAs, increasing their likelihood of approval.
Current clinical trials for tanezumab are expected to produce results by 2018. For further information, read the official press release.