Date: 2012-05-28
Type of information:
phase: 2
Announcement: results
Company: Acacia Pharma (UK)
Product: APD421 (intravenous formulation of a currently marketed dopamine D2 antagonist for the new use of prevention and treatment of nausea & vomiting)
Action mechanism:
Disease: prevention of post-operative nausea & vomiting (PONV)
Therapeutic area: Digestive diseases
Country: France, Germany, USA
Trial details: The double-blind, Phase II study, comparing three doses of APD421 with placebo, was conducted in ten major centres in France, Germany and the USA, and recruited 223 surgical patients with two or more of the four established “Apfel” risk factors for PONV. The primary endpoint was protection against PONV, defined as no vomiting or retching and no requirement for anti-emetic rescue medication in the first 24 hours after surgery.
Latest
news: * On May 28, 2012, Acacia Pharma has announced positive results from its Phase II study of APD421, in the prevention of post-operative nausea & vomiting (PONV). The study showed that APD421 significantly reduced the incidence of nausea and vomiting compared to placebo in adult surgical patients at moderate-to-high risk of suffering PONV. Vomiting and especially nausea remain a major problem for patients after surgical operations, despite the availability of a number of approved anti-emetics. APD421 was highly significantly superior to placebo at preventing PONV, the optimal dose approximately halving the PONV rate, from 67% in the placebo group to 36% (p=0.004). The incidence and severity of nausea were also significantly reduced.
APD421 was very well tolerated at all three dose levels, with no significant difference in the frequency of any adverse event for any dose of APD421 compared to placebo, and no serious adverse reactions.
No prolongation of the QT interval was seen with APD421 nor was there any evidence of sedation, psychological symptoms, extrapyramidal toxicity or gastrointestinal disturbance, a clear advantage over many other anti-emetics.
* On January 4, 2012, Acacia Pharma has announced that it has initiated a Phase II study of APD421, in the prevention of post-operative nausea & vomiting (PONV). PONV remains a clinically significant problem in patients undergoing major surgery, despite the availability of a range of anti-emetic medications. Acacia Pharma has generated positive Phase IIa clinical data when the drug was given prophylactically to cancer patients being treated with the highly emetogenic chemotherapeutic agent, cisplatin. These data indicate that APD421 has the potential to be an effective anti-emetic in man with particular value in controlling nausea.
PONV offers Acacia Pharma a rapid, low risk 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 the active ingredient. APD421 has been widely used at much higher doses as a CNS agent for 25 years. The active ingredient in APD421 is also being developed as APD403 for the prevention of chemotherapy induced nausea & vomiting (CINV).
