By Susan Heavey
WASHINGTON, Sept 16 (Reuters) - Alkermes Inc's Vivitrol drug to treat alcoholics should be approved to help treat people addicted to opioid painkillers, a U.S. Food and Drug Administration advisory panel said on Thursday.
The FDA panel of outside experts, in a 12-1 vote, said the drug could help a desperate group of people with few options to help kick their dangerous addictions.
Sales could reach $125 million by 2015 if the drug wins wider approval, according to Leerink Swann Research Analyst Steve Yoo. Vivitrol's net sales were $20.2 million for fiscal 2010, compared with $16.9 million in 2009 for Alkermes and its then-partner Cephalon Inc, according to Alkermes.
'We do need tools,' said panelist Betty Tai, director of the Center for Clinical Trials Network at the National Institute on Drug Abuse at the National Institutes of Health. 'We do need options, and we have so few options for addiction.'
Vivitrol was approved for alcohol addicts in 2006, but the biotechnology company is seeking to expand its approval. Formal FDA clearance allows the company to legally market the new use and can also impact insurance reimbursement.
FDA officials will consider the panel's recommendation as they make their final approval decision, expected by Oct. 12.
(Reporting by Susan Heavey; Editing by Bernard Orr) Keywords: ALKERMES VIVITROL/ (sheavey@thomsonreuters.com; +1 202-354-5848; Reuters Messaging: susan.heavey.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
WASHINGTON, Sept 16 (Reuters) - Alkermes Inc's Vivitrol drug to treat alcoholics should be approved to help treat people addicted to opioid painkillers, a U.S. Food and Drug Administration advisory panel said on Thursday.
The FDA panel of outside experts, in a 12-1 vote, said the drug could help a desperate group of people with few options to help kick their dangerous addictions.
Sales could reach $125 million by 2015 if the drug wins wider approval, according to Leerink Swann Research Analyst Steve Yoo. Vivitrol's net sales were $20.2 million for fiscal 2010, compared with $16.9 million in 2009 for Alkermes and its then-partner Cephalon Inc, according to Alkermes.
'We do need tools,' said panelist Betty Tai, director of the Center for Clinical Trials Network at the National Institute on Drug Abuse at the National Institutes of Health. 'We do need options, and we have so few options for addiction.'
Vivitrol was approved for alcohol addicts in 2006, but the biotechnology company is seeking to expand its approval. Formal FDA clearance allows the company to legally market the new use and can also impact insurance reimbursement.
FDA officials will consider the panel's recommendation as they make their final approval decision, expected by Oct. 12.
(Reporting by Susan Heavey; Editing by Bernard Orr) Keywords: ALKERMES VIVITROL/ (sheavey@thomsonreuters.com; +1 202-354-5848; Reuters Messaging: susan.heavey.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.