The Aliso Viejo, Calif-based company Avanir Pharmaceuticals Inc reports that results yielding from the first of a two-stage pharmacokinetic study centered on AVP-786 suggest that the drug exhibits a formulation comparable a pharmacokinetic, safety and tolerability profile to the drug AVP-923. The company notes that AVP-923 is a blend of two compounds, the active CNS ingredient dextromethorphan hydrobromide and a low-dose quinidine sulfate, which increases the bioavailability of dextromethorphan.
According to a recent news release, AVP-923 is currently being studied in several ongoing clinical trials that target neuropathic pain in multiple sclerosis (MS), behavioral symptoms of autism, agitation in Alzheimer’s disease, and levodopa-induced dyskinesia in Parkinson’s disease.
The release notes that in the current phase I study, AVP-923 was used as a control. The study is designed as a single-center, randomized, double-blind 2-way crossover to assess the pharmacokinetic profile, safety, and tolerability of single and multiple doses of AVP-786.
In an ongoing phase II clinical study of AVP-923 in central neuropathic pain in MS, the company adds that it will modify the enrollment target to 200 patients. The research is a component of the Pain Research in Multiple sclErosis (PRIME). The PRIME study is intended to evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of neuropathic pain in patients with MS. Avanir Pharmaceuticals reports that during the trial, eligible patients will receive one of three dose levels of AVP-923 containing either 45-milligram DM/10-milligram Q, 30-milligram DM/10-milligram Q, 20-milligram DM/10 milligram Q or placebo, daily for 12 weeks.
For more information on the trial, click here.
Source: Avanir Pharmaceuticals Inc