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NDA for Naltrexone Submitted for FDA Review
"This NDA submission is a major milestone in our Vivitrex development program, which comprises a comprehensive U.S. clinical trials program, manufacturing infrastructure and extensive regulatory and research expertise," commented Richard Pops, chief executive officer of Alkermes. "I'd like to take this opportunity to congratulate the many employees at Alkermes who built and integrated these capabilities and made this regulatory filing possible."
Vivitrex, an injectable, long-acting formulation of the currently approved drug naltrexone, was designed utilizing Alkermes' proprietary Medisorb® drug-delivery technology. Using the Medisorb technology, naltrexone is encapsulated in microspheres made of a biodegradable polymer that dissolve slowly and release drug at a controlled rate following intramuscular injection.
About Alcohol Dependence
In the U.S., approximately 18 million people are dependent on or abuse alcohol(1) and 2.3 million adults seek treatment each year(2). Taking prescribed medication, an important determinant in therapeutic outcomes(3), is particularly challenging for patients with addictive disorders such as alcohol dependence(4). Alcohol is causally related to more than 60 medical conditions, including heart disease, liver disease, infectious disease, and cancer(5),(6), and contributes to more than 100,000 deaths in the U.S. each year(7). In addition, alcohol dependence accounts for approximately $134 billion in lost earnings annually(8).
(1)Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC and Pickering RP. The 12-month prevalence and trends in DSM-IV alcohol abuse and dependence: United States, 1991-1992 and 2001-2002. Drug and Alcohol Dependence 2004; 74: 223-234.
(2)Alkermes Forecasting Data 2005.
* (3)Weiss RD. Adherence to pharmacotherapy in patients with alcohol and opioid dependence. Addiction 2004; 99: 1382-1392.
* (4)Rinn W, Desai N, Rosenblatt H, Gastfriend DR. Addiction denial and cognitive dysfunction: A preliminary investigation. J Neuropsychiatry Clin Neurosci 2002; 14: 52-57.
* (5)Room R, Babor T, Rehm J. Alcohol and public health. Lancet 2005; 365: 519-530.
* (6)Bagnardi V; Blangiardo M; Vecchia C, et al. Alcohol consumption and the risk of cancer. Alcohol Res Health 2001; 25(4): 263-270.
* (7)McGinnis JM, Foege WH. Mortality and morbidity attributable to use of addictive substances in the United States. Proc Assoc. Am. Physicians. 1999; 111:109-118.
* (8)US DHHS: The Economic Costs of Alcohol and Drug Abuse in the United States: Estimates, Update Methods, and Data, 2000.