Acacia Pharma has announced plans to initiate clinical trials on a drug for the prevention and treatment of nausea & vomiting and on another potential product for dry mouth.
First up is APD421, which Acacia says is an intravenous formulation of a currently-marketed dopamine D2 antagonist which has been shown to be highly effective in preclinical models of both post-operative nausea and vomiting (PONV) and chemotherapy-induced nausea & vomiting (CINV). Initially, APD421 will be developed for PONV, the Cambridge, UK-based firm says, as this provides "the most rapid development and commercialisation opportunity owing to the acute nature of the condition and the large number of surgical procedures performed".
Acacia said the active ingredient in APD421 "also has the potential to be formulated in non-injectable presentations for use by patients outside the hospital environment". PONV is currently treated using a multimodal approach, including the use of combination pharmacotherapy, but despite this about a third of patients given prophylaxis require rescue therapy in the first six hours after surgery and 40% in the first 24 hours.
The other product going into the clinic is APD515, an optimised oromucosal formulation of a currently-available drug for the new use of xerostomia, or dry mouth. APD515 has been developed as a liquid formulation to be applied directly to the inner lining of the mouth allowing it to act locally on the salivary glands, "with little or no absorption into the general circulation". Initially, it will be developed as a treatment for xerostomia in advanced cancer patients.
Acacia chief executive Julian Gilbert said both products comprise new uses for drugs currently marketed "in a completely different indication, and both work by a clinically validated mechanism of action". He added that this approach to generating new products "is able greatly to reduce development risk and time to market.”
Clinical studies for both drugs will begin in the final quarter of 2010.