By Manojna Maddipatla and Tamara Mathias
(Reuters) – A non-opioid drug developed by Pfizer and Eli Lilly met the main goals of a late-stage study, in which over half of the patients reported a significant reduction in osteoarthritis pain of the knee or hip.
The results come as the United States faces an opioid abuse epidemic, because of which health regulators have been pushing drugmakers to develop alternative pharmaceuticals.
Addiction to opioids, mainly prescription painkillers, heroin and fentanyl, have fueled overdoses which killed 49,000 people in 2017, according to provisional data from the National Institute on Drug Abuse.
Pfizer and Lilly’s drug, tanezumab, belongs to a new category of pain medications that target nerve growth factor (NGF), a protein involved in the growth of nerve cells.
If approved by regulators, it would be the first non-opioid treatment for osteoarthritis.
Regeneron and Israel-based Teva are developing their own NGF-targeting drug called fasinumab.
Data from tanezumab’s trial is meaningful since patients had moderate-to-severe pain and were unable to achieve proper relief with other treatments, including opioids, Ken Verburg of Pfizer Global Product Development said.
The results, presented at the American College of Rheumatology conference in Chicago, showed that over half of the patients who were given the drug saw a 50 percent or greater reduction in pain. Results from the trial were first announced in July.
Pfizer and Lilly plan to apply for marketing approval for tanezumab with the U.S. Food and Drug Administration next year.
Osteoarthritis is a progressive disease that causes degeneration of joints, which leads to joint pain, stiffness, and swelling.
The condition affects over 30 million patients in the United States and has limited treatment options, according to the Centers for Disease Control and Prevention.
Common cold, pain inextremity and paresthesia (tingling or numbing) were the most common adverse events in the study, with a higher frequency in both tanezumab treatment groups compared to placebo-treated patients, Pfizer and Lilly said.
0.4 percent and 1.3 percent of patients in the tanezumab 2.5 mg and 2.5/5 mg arms, respectively, discontinued treatment due to adverse events while 1.3 percent of patients in the placebo arm discontinued treatment due to adverse events, the companies said.
The overall safety profile of tanezumab observed in this study was similar to previous studies, according to the statement.
(This story has been corrected to reflect details of adverse events)
(Reporting by Tamara Mathias and Manogna Maddipatla in Bengaluru; Editing by Sai Sachin Ravikumar)