Charleston Laboratories, Inc. Initiates Patient Enrollment in a Phase 1 Study of Charleston’s Second Product, CL-H1T

Jupiter, Florida – August 3, 2015 – Charleston Laboratories, Inc., an emerging specialty pharmaceutical company, announced initiation of its second clinical development program with a Phase 1 study on its migraine drug candidate, CL-H1T.

CL-H1T contains fast-dissolving promethazine and sumatriptan. This novel migraine product is being developed as a treatment for migraine headache pain and migraine-induced nausea and vomiting (MINV).

“Many patients with migraine headaches also suffer from nausea and vomiting,” said Bernard Schachtel, MD, Chief Scientific Officer at Charleston Laboratories, Inc. “CL-H1T contains a known medication for migraine headache with specially formulated promethazine, a safe and effective anti-emetic medication,” Dr. Schachtel said. “This Phase I study will identify the bioavailability of both active ingredients in this new combination treatment.”

“This announcement is another example of the depth of our innovation pipeline and our overall commitment to research and development in the area of pain management,” said Mr. Paul Bosse, President and Chief Executive Officer at Charleston Laboratories, Inc. “We look forward to getting this product to physicians and their migraine patients who need the dual therapy that CL-H1T provides.”

Charleston Laboratories currently has a development and commercialization partner, Daiichi Sankyo, Inc., for its first product, CL-108, which is completing Phase 3 clinical trials.

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 for the development and US 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 prevention of Opioid-Induced Nausea and Vomiting (OINV).

Charleston’s product pipeline seeks to address unmet medical needs in treating 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