Neumentum today announced it has confirmed its Type B meeting with the U.S. Food and Drug Administration (FDA).
The Type B meeting, scheduled for May 8, 2018, will cover the clinical development program for Neumentum’s lead non-opioid product candidate NTM-001, an alcohol-free formulation of ketorolac in a pre-mixed bag. This novel analgesic candidate is designed for continuous intravenous infusion and has the potential to treat moderately severe acute postoperative pain that requires analgesia at the opioid level, which may help to reduce the need for opioids in clinical settings. The related, novel formulation has strong patent protection until 2032.
“Patients and caregivers have limited options when it comes to postsurgical pain management,” said Scott Shively, President and Chief Executive Officer of Neumentum. “We believe NTM-001 may provide the benefits of safe and effective pain management without the limitations and risks frequently associated with opioids. We look forward to meeting with the FDA to confirm the regulatory and development pathway for NTM-001.”
Neumentum also announced Robert B. Raffa, Ph.D., and Ilona Steigerwald, M.D., have joined the company as Chief Scientific Officer and Chief Medical Officer, respectively. Dr. Raffa shall oversee Neumentum’s scientific research operations, while Dr. Steigerwald shall lead Clinical Development, Medical and Regulatory Affairs as the company continues to advance its product candidates.
Dr. Raffa has devoted his professional career to pharmacology and understanding the balance between therapeutic utility and abuse potential of drugs. He was team co-leader for analgesics drug discovery at Johnson & Johnson, where he was involved in the elucidation of the mechanism-of-action of tramadol and the discovery of tramadol combinations. Dr. Raffa has published over 300 peer-reviewed papers, is co-author or editor of several books on pharmacology and is a co-editor of the Journal of Clinical Pharmacy and Therapeutics. He is a past president of the Mid-Atlantic Pharmacology Society and he lectures and consults worldwide on analgesics and analgesic combinations.
Dr. Steigerwald brings to Neumentum 20 years of international and cross-cultural pharmaceutical experience, with a focus on innovative treatments for acute and chronic pain. Most recently, she was Business Lead of late research and development at Grünenthal GmbH. There, she led research and development strategies for a late-stage portfolio focused in analgesia, central nervous system and orphan drugs. She has worked previously in senior medical affairs and research and development positions on a variety of opioid and non-opioid pain products and product candidates including tramadol, tramadol-acetaminophen, transdermal buprenorphine, topical lidocaine patch and tapentadol for acute and chronic pain. She has extensively published in international peer-reviewed journals and on congress abstracts and posters.
“We are delighted to welcome Bob and Ilona to the Neumentum team,” said Joseph Pergolizzi, M.D., Executive Chairman of Neumentum. “Their impressive pharmaceutical experience, coupled with their passion for the analgesic space, will further bolster our strong leadership team. Bob and Ilona will play vital roles in the development of our product candidates and transforming the future of pain management.”
