Press Release – PASADENA, Calif. – Oct 09, 2019 – Lotus Clinical Research announced that Neil Singla, MD, Chief Scientific Officer spoke at Arrowhead’s Pain & Migraine Therapeutics Summit in Washington, D.C. on Sept. 23, 2019. Arrowhead’s Pain & Migraine Therapeutics Summit is the “U.S.’s premier pain conference covering the field of pain research and therapeutics. Leaders from the biopharmaceutical industry, academia and government attend this conference to learn about the latest advances in the treatment of various types of pain and to network with colleagues from industry, academia, clinical research organizations, and government.” Dr. Singla’s presentation was on “Opioid Sparing Outcomes: Updates from the November 2018 FDA Advisory Committee,” touching on the humanitarian, clinical, and commercial importance of opioid sparing in analgesic clinical research.
Opioid sparing is when “non-opioid drugs provide analgesic relief that otherwise would have been provided by opioids. Thus, the patient receives less opioids than they otherwise would have, and as such, suffers from less opioid-related side effects.” Dr. Neil Singla, Chief Scientific Officer at Lotus Clinical Research, is a recognized industry expert on analgesic clinical research, corresponding frequently with the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) in the U.S. Food and Drug Administration (FDA) on behalf of pharmaceutical clients. According to the U.S. Department of Health and Human Services, 11.4 million people misused prescription opioids and 47,600 people have died from overdosing on opioids. This public health emergency requires the attention of pharmaceutical companies, the FDA, and clinical researchers to collaborate in an effort to combat the opioid epidemic.
Dr. Singla closed his presentation with the following information: “There are several non-opioid drugs that provide analgesia and therefore, reduce opioid consumption. The clinical phenomenon exists, but it has been difficult to demonstrate statistically. Demonstrating opioid sparing via Opioid-Related Adverse Events (ORAEs) is difficult, and the pathway to success involves appropriate exploratory Phase 2 work to understand potency and models, and clear regulatory communication utilizing the current ‘rule structure’ above and focus regulatory communication on the details of how you will achieve your claim within this ‘rule structure.’ Using an opioid-free patient’s endpoint could provide a solution.”
“Lotus Clinical Research is a dedicated analgesic CRO and clinical research site, which is currently working on a number of clinical trials to provide opioid alternatives for pain relief and management. Our mission at Lotus is to reduce prescription drug misuse and abuse,” said Dr. Singla. “We hope that our work will help patients with acute or chronic pain lead as normal of a life as possible, without the potentially dangerous side effects from opioids.“ Based in Pasadena, California, Lotus Clinical Research is an established leader in acute and chronic pain CROs and research sites within the U.S. Since its inception in 2001, Lotus Clinical Research has conducted over 350 pain studies.
About Lotus Clinical Research: Lotus Clinical Research is a specialty analgesic CRO, research site and regulatory consulting firm supporting all phases of development for analgesic treatments and has played a role in 10 analgesic FDA approvals. Led by Dr. Neil Singla, Lotus focuses on optimizing design/conduct of clinical trials in pain providing scientific leadership at every step of the development process. In assisting with the advancement of pain therapies, Lotus Clinical Research seeks to invent and operationalize research methods that improve study design and conduct for analgesic trials, which supports our mission to help discover novel analgesics that reduce prescription drug misuse and abuse.