ALISO VIEJO, CA, USA I July 1, 2013 I Avanir Pharmaceuticals, Inc. (AVNR) today announced completion of patient enrollment in the company’s phase II, placebo controlled study testing three doses of AVP-923 for the treatment of central neuropathic pain in multiple sclerosis. Top-line results from this study are expected in the fourth calendar quarter of 2013.
“Final completion of enrollment in PRIME is an important milestone in the AVP-923 development pathway,” said Joao Siffert, MD, chief scientific officer at Avanir. “We are looking forward to the results from this study to help guide design of our phase III studies in neuropathic pain.”
About the PRIME Study
The objectives of the PRIME (Pain Research In Multiple sclErosis) study are to evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis. The trial is a multicenter, randomized, double-blind, placebo-controlled, 4-arm parallel group study. Eligible patients receive one of three dose levels of AVP-923 containing either 45mg DM/10 mg Q, 30mg DM/10mg Q, 20mg DM/10mg Q or placebo, daily for 12 weeks. The primary efficacy endpoint will be measured based on the Numeric Pain Rating Scale (PRS) as recorded in patient diaries. Primary analysis of this endpoint will correlate pain scores with dextromethorphan plasma concentrations. Secondary analysis will correlate pain scores with AVP-923 dose and also compare pain scores for those treated with placebo versus drug in each dose group. Secondary assessments include measures of fatigue, impact of MS on daily life, sleep quality, spasticity, cognition and depression. Standard safety assessments were also conducted.
About AVP-923
AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is being studied in several ongoing company sponsored Phase II clinical trials including agitation in Alzheimer’s disease, neuropathic pain in Multiple Sclerosis, levodopa-induced dyskinesia in Parkinson’s disease, and an investigator initiated study of behavioral symptoms of autism in adults. AVP-923 is an investigational drug not approved by the FDA.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
SOURCE: Avanir Pharmaceuticals
Post Views: 660
ALISO VIEJO, CA, USA I July 1, 2013 I Avanir Pharmaceuticals, Inc. (AVNR) today announced completion of patient enrollment in the company’s phase II, placebo controlled study testing three doses of AVP-923 for the treatment of central neuropathic pain in multiple sclerosis. Top-line results from this study are expected in the fourth calendar quarter of 2013.
“Final completion of enrollment in PRIME is an important milestone in the AVP-923 development pathway,” said Joao Siffert, MD, chief scientific officer at Avanir. “We are looking forward to the results from this study to help guide design of our phase III studies in neuropathic pain.”
About the PRIME Study
The objectives of the PRIME (Pain Research In Multiple sclErosis) study are to evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis. The trial is a multicenter, randomized, double-blind, placebo-controlled, 4-arm parallel group study. Eligible patients receive one of three dose levels of AVP-923 containing either 45mg DM/10 mg Q, 30mg DM/10mg Q, 20mg DM/10mg Q or placebo, daily for 12 weeks. The primary efficacy endpoint will be measured based on the Numeric Pain Rating Scale (PRS) as recorded in patient diaries. Primary analysis of this endpoint will correlate pain scores with dextromethorphan plasma concentrations. Secondary analysis will correlate pain scores with AVP-923 dose and also compare pain scores for those treated with placebo versus drug in each dose group. Secondary assessments include measures of fatigue, impact of MS on daily life, sleep quality, spasticity, cognition and depression. Standard safety assessments were also conducted.
About AVP-923
AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is being studied in several ongoing company sponsored Phase II clinical trials including agitation in Alzheimer’s disease, neuropathic pain in Multiple Sclerosis, levodopa-induced dyskinesia in Parkinson’s disease, and an investigator initiated study of behavioral symptoms of autism in adults. AVP-923 is an investigational drug not approved by the FDA.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
SOURCE: Avanir Pharmaceuticals
Post Views: 660
