Avanir Pharmaceuticals Announces Enrollment of First Patient in Study of AVP-923 for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease
"This is an important study of a compound with multifaceted pharmacology for the management of levodopa induced dyskinesia in Parkinson's disease," said
Top line data for this study is expected in the second half of calendar 2014.
About the Study
This proof-of-concept, double blind, randomized, crossover study will compare AVP-923 (45 mg of dextromethorphan / 10 mg of quinidine) with placebo for treatment of LID. The study will enroll approximately 16 PD patients across three study centers in the US and
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 and neuropathic pain in Multiple Sclerosis. AVP-923 can interact with other medications and cause serious side effects and should not be used in patients taking certain drugs and in patients with specific cardiovascular risk factors. These are not all the risks from use of AVP-923. AVP-923 is an investigational drug and is not approved for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.
About Parkinson's Disease
Over one million people in the US and an estimated 5 million people globally suffer from Parkinson's disease, a neurodegenerative disorder leading to diminished production of dopamine, a key neurotransmitter, resulting primarily in progressive impairment of motor function characterized by tremors, rigidity and slow movements.
Dyskinesia often occurs as a disabling side effect of long-term treatment of Parkinson's with levodopa and presents as jerky, uncoordinated motions or smooth tics of the upper or lower extremities. Current treatment options are limited and not always effective.
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Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Avanir's operating performance and financial position, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new products domestically and internationally, including the risks and uncertainties associated with meeting the objectives of the clinical study of AVP-923 for levodopa-induced-dyskinesia in Parkinson's disease, including, but not limited to, continued funding, delays or failures in enrollment, and the occurrence of adverse safety events, obtaining additional indications for commercially marketed products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the
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