Jupiter, Florida – September 9, 2014 – Charleston Laboratories, Inc., an emerging specialty pharmaceutical company focused on the research and development of novel pain products, announced two key clinical updates for the company. The company has submitted an Investigational New Drug Application (“IND”) to the U.S Food and Drug Administration (“FDA”) Division of Neurology Products (DNP) for the clinical development of CL-H1T as a novel treatment for patients who suffer from migraine pain and migraine induced nausea or vomiting. Additionally, the FDA’s Division of Pulmonary, Allergy and Rheumatology Products (“DPARP”) has granted Charleston’s request for a Type B Pre-Investigational New Drug meeting (“Pre-IND”) to discuss the proposed Investigational New Drug, CL-AT-313, as a novel treatment for the relief of cough and other symptoms associated with upper respiratory allergies or a common cold.
“Both of these developments demonstrate Charleston’s continued ability to advance novel drug candidates,” said Paul Bosse, President and Chief Executive Officer of Charleston Laboratories. “Our successfully completed Phase 3 study with our lead asset CL-108 combined with the clinical developments around CL-H1T and CL-AT-313 show Charleston’s core strengths and abilities to leverage our rich pipeline of products. We will continue to aggressively diversify our pipeline with our sights on defined milestones that benefit both patients and our stakeholders.”
Charleston Laboratories, Inc. is a privately held, specialty pharmaceutical company focused on the research and development of novel pain products to significantly reduce the burdensome side effects related to opioid analgesics and other products. The Company recently announced a strategic collaboration for the development and U.S. commercialization of Charleston Laboratories’ novel hydrocodone combination products, including CL-108, being studied for the treatment of moderate to severe acute pain as well as the reduction of Opioid-Induced Nausea and Vomiting (OINV).
Charleston’s product pipeline currently seeks to address unmet needs in 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). Charleston Laboratories intends to enter into other discovery and commercialization alliances with partners motivated to introduce novel pain therapies that reduce the burdensome side effects related to opioid analgesics and other products. For more information, please visit www.charlestonlabs.com.
Charleston Laboratories, Inc.