Pharmaceutical company, Neumentum committed to transforming the way acute and chronic pain are treated-without opioids asserted the confirmation of Type B meeting with the U.S FDA (Food and Drug Administration). The company also declared its appointment of Robert B. Raffa, Ph.D., as Chief Scientific Officer and IIona Steigerwald, M.D., as Chief Medical Officer.
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.
Scott Shively, President and Chief Executive Officer of Neumentum said “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.Steigerwald brings on board 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.
Joseph Pergolizzi, M.D., Executive Chairman of Neumentum said “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.”