Dr. Neil Singla, Chief Scientific Officer of Lotus Clinical Research will discuss opioid sparing endpoints and criteria for submission of opioid-sparing labels to the FDA at the 11th Annual Pain and Migraine Therapeutics Summit, taking place in San Diego, CA on September 27-28, 2017.
MINNEAPOLIS, MN (PRWEB) AUGUST 22, 2017
One of the biggest opportunities to reduce the dependency on opioids in pain management is the practice of opioid-dose sparing. Opioid-dose sparing refers to the reduction of opioid dosage by combining with a non-opioid. This practice has shown promising results, including with non-steroidal anti-inflammatory drugs (NSAIDs).
The potential for new therapies to replace opioids and/or reduce dosages, however, is limited by the success of clinical trials and the utilization of effective endpoints for judging efficacy. Dr. Neil Singla, Chief Scientific Officer of Lotus Clinical Research will discuss these endpoints and criteria for submission of opioid-sparing labels to the FDA at the 11th Annual Pain and Migraine Therapeutics Summit, taking place in San Diego, CA on September 27-28, 2017. For more information, please visit: http://paintherapeuticsummit.com/brochure.
Dr. Singla will outline the regulatory criteria required when seeking an opioid-sparing claim on drug labels. He will provide examples of recently approved drugs for which opioid-sparing claims were sought, both successfully and unsuccessfully. He will also review labels, protocol designs and endpoints, and resulting publications for these drugs. Lastly, he will elaborate on the types of opioid-sparing labels the FDA awards.
Lotus Clinical Research, a specialty analgesic CRO and research site, has performed more than 100 analgesic clinical trials, as well as guided several analgesic agents through FDA approval. Dr. Singla’s expertise will provide attendees of the conference will an informative overview of maneuvering these labels. For more information on the services provided by Lotus Clinical Research, please visit: http://www.lotuscr.com/.
This annual conference provides a discussion platform for key industry and academic research leaders to network and deliberate many themes, including cutting-edge drug discovery science, preclinical development trends, analysis of novel clinical-stage pain therapies and newly marketed products. We will highlight the field’s most important developments in recent years, including: Nav 1.7 sodium channel blocker research, safer opioid analgesics, anti-CGRP receptor monoclonal antibodies, abuse-deterrent opioid development and more.
Please visit http://www.paintherapeuticsummit.com/agenda for the full agenda, which also includes numerous presentations covering clinical trial design and endpoints, regulatory and commercial issues, tools and technologies supporting pain drug discovery, and new scientific discoveries.