Charleston Laboratories, Inc. Completes Patient Enrollment in a Phase 3

Jupiter, Florida – April 6, 2015 – Charleston Laboratories, Inc. announced completion of patient enrollment in another Phase 3 clinical trial evaluating the use of CL-108 for the treatment of moderate to severe pain associated with osteoarthritis of the knee or hip. The study is being conducted at 17 research centers across the U.S.

CL-108 is a tablet containing 7.5 mg of hydrocodone and 325 mg of acetaminophen with 12.5 mg of fast-absorbed promethazine. This novel therapy is being developed as a treatment for moderate to severe pain and the prevention of opioid-induced nausea and vomiting, or OINV.

“We are very pleased to have achieved this milestone,” said Bernard Schachtel, MD, Chief Scientific Officer at Charleston Laboratories. “In this study we have a broad representation of the adult population who suffer ‘flares’ of osteoarthritis of the knee or hip. Under real-life conditions, these patients are evaluating the effectiveness and safety of CL-108 while doing their regular daily activities.”

“Charleston Laboratories prides itself on the quality of all our R&D activities,” said Mr. Paul Bosse, President and Chief Executive Officer at Charleston Laboratories. “Recently we completed a pivotal pharmacokinetic study as we progress the development of CL-108. The early completion of patient enrollment in this major study on patients with arthritic pain speaks to the planning and management of our research program as well as the care and dedication of the many physicians and nurses who are conducting this study throughout the U.S. We look forward to learning the results of this informative Phase 3 study.”

About Charleston Laboratories, Inc.

Charleston Laboratories, Inc. is a privately held, specialty pharmaceutical company focused on the research and development of novel pain products that prevent the burdensome side effects related to opioid analgesics and other products. The Company recently announced a strategic collaboration with Daiichi Sankyo, Inc. for the development and U.S. commercialization of Charleston Laboratories’ novel hydrocodone products, including CL-108, being studied for the treatment of moderate to severe pain as well as the prevention 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 prevent the burdensome side effects related to opioid analgesics and other products. For more information, please visit www.charlestonlabs.com.

Contact

Megan Driscoll
Charleston Laboratories, Inc.
mdriscoll@charlestonlabs.com
+917.633.4380