PALM SPRINGS, Calif. — Phase 3 data on a treatment that is designed to address moderate-to-severe pain while also reducing or preventing opioid-induced nausea and vomiting were presented at the 34th Annual Scientific Meeting of the American Pain Society held here this week.
CL-108 (Daiichi Sankyo) contains 12.5 mg immediate-release promethazine with 7.5 mg hydrocodone and 325 mg acetaminophen. The treatment ensures delivery of promethazine, an anti-emetic therapy, prior to the onset of the pain-relieving properties of hydrocodone and acetaminophen to help prevent nausea and vomiting, according to a company press release.
The data were presented in separate posters at the meeting.
In the first poster, researchers reported that they were looking to determine the occurrence and severity of OINV in patients without a clear-cut history of OINV through the use of a Nausea-Prone Questionnaire (NPQ) to identify evidence of previous OINV or other conditions that might predispose patients to nausea and/or vomiting.
The researchers concluded: “a surprisingly high proportion ( 60%) of patients who have no history of previous OINV but who are only possibly at risk of OINV actually develop this condition after using an opioid-containing analgesic.”
The second poster included subgroup analysis of patients undergoing oral surgery who did not have immediate post-operative vomiting.
That analysis examined the incidence of OINV in patients without immediate post-operative nausea and vomiting and the prophylactic anti-emetic effect of CL-108 compared to 7.5 mg hydrocodone/325 mg acetaminophen.
The researchers in that study concluded: “Moderate or severe nausea and single-episode or repeat vomiting occurred in 49% and 36% of patients treated with hydrocodone/acetaminophen over the initial 48 post-operative hours when most patients treated pain. These outcomes were significantly reduced for patients who used CL-108, representing a 41% relative risk reduction for the occurrence of nausea and 50% relative reduction in the risk of vomiting.” Fewer patients who received CL-108 also used anti-emetics.