Charleston Laboratories, Inc, an emerging specialty pharmaceutical company, has completed its scheduled pre-IND meeting with the US 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 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 Programme 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 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.