Charleston Laboratories, Inc, an emerging specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting related to opioid analgesics and other pain associated disease states, announced today the completion of its scheduled Pre-IND meeting with the U.S Food and Drug Administration (FDA) for the proposed Investigational New Drug, CL-H1T, as a novel treatment for patients who suffer from migraine pain and migraine induced nausea or vomiting.
“The Pre-IND meeting with FDA’s Division of Neurology Products (DNP) was positive and productive” said Mr. John Ameling, Vice President of Regulatory Affairs at Charleston. “The questions we raised in the Briefing Document were answered and clarified in the meeting. I am confident that Charleston will be able to conduct the Drug Development Program that DNP agreed to and submit an approvable a 505 (b) (2) New Drug Application.”
“From a drug development standpoint, the information we received from FDA during our Pre-IND meeting will facilitate our ability to complete our proposed program on CL-H1T” said Dr. Bill Kozarek, Charleston’s Vice President of Product Development. “I am very excited to advance the CL-H1T program to demonstrate significant benefits for patients who suffer from migraines, relieving pain and reducing or eliminating nausea and vomiting.”
Charleston Laboratories, Inc is a specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting, the two most burdensome side effects related to opioid analgesics and other pain associated disease states. Charleston’s new products will address Opioid Induced Nausea and Vomiting (OINV), Postoperative Nausea and Vomiting (PONV), Chemotherapy Induced Nausea and Vomiting (CINV), Radiation Induced Nausea and Vomiting (RINV), and Migraine Induced Nausea and Vomiting (MINV). In addition, Charleston is developing other products without acetaminophen to reduce the potential for liver injury and formulations with abuse deterrent technologies designed to curb misuse and abuse. Charleston Laboratories intends to enter into discovery and commercialization alliances with partners motivated to introduce novel pain therapies that eliminate or significantly reduce nausea and vomiting.