INDIANAPOLIS, IN-- An Indianapolis company is a step closer to introducing a new form of pain medication it said could be an alternative to opioid use.
Eli Lilly and Company and Pfizer announced Tuesday, the FDA granted fast track designation for Tanezumab for treating chronic pain in patients with osteoarthritis and chronic low back pain. It's an injection given every 8 weeks. The company said if approved, it would be the first of its kind on the market.
This all comes as the FDA looks at ways it can fight the nationwide opioid crisis.
"This will be an alternative to opioid use in the United States," Christa Shaw said.
She's the vice president and president of Lily Bio-Medicines, but the mission to find a non-opioid chronic pain medication is personal for her.
"I have a sister who's living with cancer pain and so although that phase three study is a little bit longer behind, I see her struggling with the pain and struggling with the fact of I don't want to get addicted to opioids so she takes as little possible so then she has pain," Shaw said.
Shaw said the FDA's fast track designation will give the companies greater access to the FDA as they work through the review and approval process. Right now, there are six phase three studies ongoing involving thousands of patients. The company expects those results to begin reporting next year.
Shaw said in completed studies they found patients had pain reduction.
"What we found with Tanezumab is it doesn't cross into the brain and so what that means is patients don't experience that euphoria or the mood effects, the things that can really make a patient become addiction or abuse potential or become dependent on opioids," she said.
Eli Lilly and Company said in previous clinical studies, peripheral edema, join pain, muscle pain and transient abnormal cutaneous sensations, such as burning, tingling and numbness, were the most common adverse events associated with Tanezumab administration. They occurred in less than 10 percent of patients treated with the drug.