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Acacia Pharma Initiates Pivotal Phase 3 Studies with APD421 in Post-Operative Nausea & Vomiting (PONV)
Date:9/17/2013

e therapy in the first 6 hours after surgery, representing a substantial unmet medical need and commercial opportunity.

PONV offers Acacia Pharma a rapid development opportunity for APD421, owing to the acute nature of the condition, the large number of surgical procedures and the well-documented, benign safety profile of amisulpride, which has been widely used at much higher doses as an antipsychotic agent for 25 years. Amisulpride is also being developed by Acacia Pharma as APD403 for the prevention of chemotherapy induced nausea & vomiting (CINV).

Dr Gabriel Fox, Acacia Pharma's Chief Medical Officer commented: "Our Phase 3 programme will give a very robust read-out on the efficacy and safety of APD421 compared to placebo in a broad population of surgical patients at risk of suffering PONV. We have been highly encouraged by the positive feedback from regulatory agencies and experienced clinical investigators in Europe and the US and look forward to seeing the data from these studies."

Acacia Pharma's CEO, Dr Julian Gilbert, added: "We are delighted to have initiated these Phase 3 studies so soon after securing our recent funding. The Phase 2 data we generated last year were excellent and we are confident of obtaining similar results in these bigger pivotal clinical studies."

About Acacia Pharma

Acacia Pharma (http://www.acaciapharma.com) is a pharmaceutical company focused on cancer supportive care, a rapidly developing commercial opportunity. The growth in the cancer supportive care market has been driven by the increasing incidence of cancer, the expansion of effective cancer therapies and the desire to improve both the effectiveness of treatment and the quality of life of cancer patients.

Acacia Pharma has generated a pipeline of product opportunities addressing a range of supportive care i
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