Avanir intends to start the trial by evaluating AVP-786 for the adjunctive treatment of major depressive disorder (MDD) during the third quarter of 2014.
Avanir Pharmaceuticals chief medical officer Joao Siffert said the endorsement of the Phase II trial by the division of Psychiatry Products at the FDA lends support for the expedited development path for AVP-786 and is allowing it to reference the extensive data generated during AVP-923 development programs.
"This is an important moment for the company, as this will be our first clinical study evaluating AVP-786 in patients," Siffert said.
"There are millions of patients with MDD who do not respond adequately to existing therapies. With a mechanism of action addressing multiple neurotransmitter systems involved in depression, AVP-786, if approved, could offer a potential new treatment option for these patients. We look forward to initiating our clinical research program in the coming months."
The submission of this IND represents the first step in the company’s plan to develop AVP-786 for a broad array of neurological and psychiatric conditions.
The Phase II trial will evaluate the efficacy and safety of AVP-786 in patients suffering from MDD who have had an inadequate response to commonly prescribed antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).
About 200 patients in the US will be enrolled in the multicenter, randomized, double-blind, placebo-controlled proof-of-concept trial.
During the trial, eligible patients will be randomized to receive either AVP-786 or placebo for 10 weeks.
Image: Avanir’s Phase II trial of AVP-786 will enroll about 200 patients in the US. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net