Pain is one of the most frequent symptoms facing today’s society. To treat short term pain that is moderate to severe in intensity, physicians rely on opioid analgesics such as hydrocodone and acetaminophen combination products. In fact, with over 131 million prescriptions of hydrocodone and acetaminophen products annually, this combination is the most widely prescribed medicine in the US (more than other commonly used products such as statins for cholesterol reduction and ACE inhibitors for high blood pressure). Even with the widespread use of hydrocodone-containing products for the treatment of moderate to severe pain, however, 30-60% of treated patients experience opioid induced nausea and vomiting (OINV), causing poor pain control and low overall patient satisfaction.
Charleston has recognized that physicians and patients do not have the ideal opioid analgesic for the treatment of moderate to severe acute pain because the currently available commercial products carry this high incidence of nausea and vomiting. The company’s lead product, CL-108, is designed to meet this need. Currently in Phase 3 clinical development, CL-108 is a novel bi-layered tablet containing 12.5 mg of immediate-release promethazine with a modified release formulation of 7.5 mg of hydrocodone and 325 mg of acetaminophen. CL-108 will be indicated as treatment for patients who suffer from moderate to severe acute pain while preventing Opioid Induced Nausea & Vomiting (OINV).
CL-108 has the potential to benefit millions of patients who suffer from OINV associated with their pain management regimen.
Charleston’s objective is to submit the New Drug Application for CL-108 to the US Food and Drug Administration in the 4th Quarter of 2015.