UK firm Acacia Pharma says a fourth and pivotal late-stage study assessing Baremsis as a rescue treatment for patients experiencing post-operative nausea & vomiting (PONV) despite prophylactic therapy has hit its targets, pushing the drug closer to US filing.
PONV can have a detrimental impact on surgical outcomes and significantly impede the post-operative recovery process, potentially delaying hospital discharge and leading to unanticipated readmissions. Therefore, better management of the condition can decrease hospital costs and improve patient outcomes/satisfaction, the group noted.
Surgical patients at moderate or high risk of PONV are given prophylactic antiemetics prior to surgery, with standard-of-care based upon 5HT3 antagonists and corticosteroids, but up to 40 percent still develop the condition and thus need further treatment with a difference class of antiemetic. Baremsis is a dopamine antagonist antiemetic and thus "is able to fulfil this important unmet medical need and better manage PONV".
Acacia Pharma has now completed four pivotal Phase III studies, which all met their primary endpoints and will form the basis of an efficacy and safety package which Acacia now intends to submit to the US Food and Drug Administration in the first half of this year. A "broad and unique approval" for Baremsis for the rescue treatment and prophylaxis of PONV, alone and in combination with other therapies, is being targeted.
"No other anti-emetic has a specific label for treating this significant unmet need and we intend to position Baremsis as the drug of choice for treating the 30 percent-40 percent of surgical patients who suffer PONV despite prior prophylaxis, as well as for combination prophylaxis in high-risk patients," said Dr Julian Gilbert, Acacia chief executive.
The firm also noted that "detailed" trial data will be presented "in due course" at relevant scientific meetings and submitted for publication in a peer-reviewed journal.