Phase 3 study of CL-108 meets primary endpoints

Charleston Laboratories and Daiichi Sankyo have 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. It 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 study in over 550 patients who experienced moderate to severe pain after bunionectomy surgery. Results from the study demonstrated  significant pain relief and prevention of OINV by CL-108.

 OINV can affect a patient’s ability to achieve effective pain control

“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 U.S. FDA review.”