Phase 2 Study of AVP-923 for Central Neuropathic Pain in MS
Avanir Pharmaceuticals announced that it has filed an IND application for its Phase 2 study of AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis (MS). Following approval, Avanir expects to enroll approximately 400 patients at 65 centers in the U.S. and internationally. The objectives of the study are to evaluate the safety, tolerability, and efficacy of three dose levels of AVP-923 capsules.
AVP-923 is a combination of two compounds: the active ingredient dextromethorphan hydrobromide and the enzyme inhibitor quinidine sulfate (a CYP450 2D6 inhibitor), which serves to increase the bioavailability of dextromethorphan. The dosage form of AVP-923 of 20mg dextromethorphan hydrobromide/10mg quinidine sulfate (twice daily) is approved by the FDA under the brand name NUEDEXTA capsules which is indicated for the treatment of pseudobulbar affect (PBA).
For more information call (949) 389-6700 or visit www.avanir.com