Charleston Laboratories Inc., a privately held, specialty pharmaceutical company, and Daiichi Sankyo Inc., a global pharmaceutical company, announced that a third phase 3 clinical trial of CL-108, an opioid-containing formulation, met its primary endpoints. CL-108 is a bi-layered tablet containing 7.5 mg of hydrocodone and 325 mg of acetaminophen uniquely formulated with 12.5 mg of rapid-release promethazine. This novel formulation is being developed as a treatment for moderate to severe pain and the prevention of opioid-induced nausea and vomiting (OINV).

This recently completed phase 3 clinical trial was a randomized, double-blind, placebo- and active-controlled study in over 550 patients in the US who experienced moderate to severe pain after bunionectomy surgery (removal of bunions from the foot). Results from the study demonstrated significant pain relief and prevention of OINV by CL-108 (both p<0.001).

"Meeting the primary endpoints of this pivotal phase 3 study marks an important  milestone in the development of CL-108 as a potential treatment option for patients with moderate to severe pain while preventing opioid-induced nausea and vomiting,” said Bernard Schachtel, M.D., chief scientific officer at Charleston Laboratories, Inc.

“OINV is a condition that can affect a patient’s ability to achieve effective pain control,” said Mark T. Marino, M.D., vice president, clinical development at Daiichi Sankyo, Inc.

“Daiichi Sankyo is committed to developing medicines, such as CL-108 that address unmet patient needs for pain management."

Mr. Paul Bosse, president and chief executive officer at Charleston Laboratories, Inc., said, “This major milestone marks a critical step forward in the development of CL-108 and the joint Charleston Laboratories and Daiichi Sankyo clinical research programme. We look forward to providing the full results of this study, as well as additional reports on CL-108  in the near future, as we prepare to submit a New Drug Application (NDA) for US FDA review.”

“The synergy between Charleston Laboratories and Daiichi Sankyo has enabled great progress in the development of CL-108,” said Ken Keller, president, US commercial of Daiichi Sankyo, Inc.

“If approved, CL-108 represents an opportunity to deliver on our commitment to bring important new therapies to patients and to continue to build the Daiichi Sankyo US portfolio of medicines in the area of pain management.”

Further analysis of the study results is ongoing and the results will be submitted to an upcoming medical conference and peer-reviewed publication.