Alkermes, Inc. (NASDAQ: ALKS) today announced that NASDAQ has halted trading of the company’s common stock this morning. The Psychopharmacologic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) meets today to review the company’s supplemental New Drug Application (sNDA) for VIVITROL ® (naltrexone for extended-release injectable suspension) for opioid dependence.
The sNDA for VIVITROL for the treatment of opioid dependence was submitted in April 2010. In May the FDA designated the sNDA a priority review, a designation that accelerates the FDA’s target review timeline from ten to six months for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. With priority review, the Prescription Drug User Fee Act (PDUFA) date for the FDA’s decision regarding approval of the VIVITROL sNDA for opioid dependence is October 12, 2010.
About Opioid Dependence
A chronic brain disease, opioid dependence is characterized by cognitive, behavioral and physiological symptoms in which an individual continues to use opioids despite significant harm to oneself and others. 1 The misuse of opioids can create euphoria of such intensity that it reinforces drug taking behavior and may lead to opioid dependence or addiction. 2 In addition to the use of heroin, an illegal opioid drug, opioid abuse and addiction includes the non-medical use of opioid analgesics, including prescription pain relievers, and represents a growing public health problem in the U.S. According to the 2008 U.S. National Survey on Drug Use and Health, an estimated 1.3 million people aged 18 or older were dependent on pain relievers or heroin. 3 The overall cost of prescription opioid abuse in the U.S. has been estimated at $9.6 billion, including health care, criminal justice, and workplace costs, 4 and the overall cost of heroin addiction in the U.S. has been estimated to be approximately $22 billion, including productivity losses, criminal activity, healthcare and social welfare costs. 5
About VIVITROL
VIVITROL is the first and only once-monthly, extended-release injectable medication for the treatment of alcohol dependence and was approved by the FDA in April 2006. The proprietary Medisorb ® drug delivery technology in VIVITROL enables the medication to be gradually released into the body at a controlled rate over a one-month time period. For a copy of the VIVITROL full prescribing information, including boxed warning, please visit www.vivitrol.com or call 1-800-VIVITROL (1-800-848-4876).
IMPORTANT SAFETY INFORMATION FOR VIVITROL
VIVITROL is contraindicated in patients receiving opioid analgesics or with current physiologic opioid dependence, patients in acute opiate withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, or in patients who have previously exhibited hypersensitivity to naltrexone PLG, carboxymethylcellulose or any other components of the diluent.
