Healthcare Industry News:  antiemetic 

Biopharmaceuticals

 News Release - August 12, 2016

Acacia Pharma Announces Positive Results From a Pivotal Phase 3 Trial of BAREMSIS(TM) for the Treatment of Post-Operative Nausea & Vomiting

BAREMSIS Now Shown to Treat PONV, as Well as Prevent it

CAMBRIDGE, England, August 12, 2016 -- (Healthcare Sales & Marketing Network) -- Acacia Pharma Group plc ("Acacia Pharma"), the supportive care company developing products for US and international markets, announces positive results from a pivotal Phase 3 study investigating BAREMSIS™ (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting ("PONV"). These data further support the efficacy of BAREMSIS which has previously been shown to prevent PONV alone, and in combination with standard anti-emetics in pivotal Phase 3 prophylaxis studies.

Dr Julian Gilbert, Acacia Pharma's CEO commented: "We are delighted with these data demonstrating that BAREMSIS is safe and effective at treating patients suffering PONV after surgery. It confirms our confidence in the dopamine antiemetic mechanism of action, and that BAREMSIS is effective at treating, as well as preventing, PONV. Our objective is to seek approval for BAREMSIS for the treatment and prophylaxis of PONV alone and in combination, which will provide us with a broad and unique label once approved. No other antiemetic has a PONV treatment claim following failed prophylaxis with standard antiemetics and no other antiemetic has a combination use claim in PONV prophylaxis."

This Phase 3 treatment trial compared two doses of BAREMSIS, a novel dopamine D2/D3 antagonist antiemetic, against placebo in patients with established nausea and/or vomiting after surgery, who had not previously received any prophylactic antiemetics. The study took place in leading institutions in the USA, Canada, France and Germany and recruited 568 patients. The primary endpoint was the successful resolution of the episode of PONV (no recurrence of vomiting or requirement for further antiemetic rescue) in the 24-hour period after treatment, termed a complete response. Both doses of BAREMSIS significantly improved the complete response rate when compared to placebo (p<0.025), the magnitude of effect was consistent with previous trial results. Detailed data will be presented in due course at relevant scientific meetings and submitted for publication in a peer-reviewed journal.

A second pivotal Phase 3 treatment study of BAREMSIS in surgical patients who develop PONV despite receiving prior prophylaxis is ongoing. Acacia Pharma has already shown BAREMSIS prevents PONV in pivotal Phase 3 prophylaxis studies, alone and in combination with other antiemetics. The results from these studies, along with the results announced today, will complete the efficacy package Acacia Pharma aims to submit to the US FDA as part of its New Drug Application (NDA), looking to gain approval for BAREMSIS for the treatment and prophylaxis of PONV alone and in combination.

About Acacia Pharma

Acacia Pharma is developing supportive care product opportunities for post-surgical and cancer patients. Patients and healthcare professionals urgently need new and improved interventions in these rapidly expanding, yet poorly served, areas of supportive care, to improve treatment outcomes and patients' quality of life.

Acacia Pharma has generated its pipeline of product opportunities using a commercially driven approach to product discovery, identifying completely new uses for marketed drugs, a process termed repurposing. This strategy leads to opportunities with a higher probability of success and enables more rapid development. All of Acacia Pharma's repurposed programmes are optimised for their new use, by using a new route of delivery and dose that are appropriate for the new indication identified, thereby differentiating them from the original marketed product.

The lead project, BAREMSIS for post-operative nausea & vomiting (PONV), has generated positive results in Phase 3 clinical studies. Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV) has successfully completed one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy. In addition, the company has completed a Phase 2 study with APD515 for xerostomia (dry mouth) in advanced cancer patients and a Phase 2a study with APD209 for cancer cachexia (muscle wasting).


Source: Acacia Pharma

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.