By Bill Berkrot
NEW YORK, July 22 (Reuters) - European health regulators recommended on Thursday restricting the use of Cephalon's sleep disorder drug Provigil for treating narcolepsy only, over concerns that risks may outweigh the benefits of the medicine in other uses.
The European Medicines Agency said doctors and patients should no longer use medicines that contain modafinil -- the active ingredient in Provigil -- for sleep apnea, chronic shift work sleep disorder or other previously approved uses.
Cephalon, whose shares fell nearly 2 percent, said it will request a re-examination of the agency's assessment.
Analysts said any damage from new Provigil restrictions in Europe should be limited.
The 'recommendation to restrict the use of Provigil in Europe will have a minimal impact on earnings,' Louise Chen, an analyst for Collins Stewart, said in a research note.
Robert W Baird analyst Thomas Russo said he still expects Cephalon to raise its full year forecast when it reports second-quarter earnings next week due to growth of the cancer drug Treanda and U.S. price increases on Provigil.
A review of the drug was initiated by European regulators over a number of safety concerns related to psychiatric disorders, skin and subcutaneous tissue reactions as well as significant off-label use and potential for abuse, the agency said.
On the basis of the available data the agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the drug only outweighs the risks in the treatment of narcolepsy, a chronic sleep disorder characterized by excessive daytime sleepiness.
Narcolepsy was the original use for which Provigil was approved.
For all other uses European officials said safety risks outweighed evidence of clinical efficacy.
The CHMP also identified particular cardiovascular risks with modafinil and recommended that it not be prescribed to patients with uncontrolled high blood pressure or irregular heart rhythms.
'Modafinil has been used safely and effectively for its licensed indications in Europe for many years and we believe the risk/benefit profile in all approved indications is positive,' Cephalon spokeswoman Candace Steele Flippin said.
Modafinil is currently licensed in 21 countries in Europe.
Cephalon shares closed down $1.14, or 1.9 percent, at $59.89 on Nasdaq.
(Reporting by Bill Berkrot, editing Bernard Orr and Carol Bishopric) Keywords: CEPHALON/EUROPE (bill.berkrot@thomsonreuters.com; +1 646 223-6030; Reuters Messaging: bill.berkrot.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.
NEW YORK, July 22 (Reuters) - European health regulators recommended on Thursday restricting the use of Cephalon's sleep disorder drug Provigil for treating narcolepsy only, over concerns that risks may outweigh the benefits of the medicine in other uses.
The European Medicines Agency said doctors and patients should no longer use medicines that contain modafinil -- the active ingredient in Provigil -- for sleep apnea, chronic shift work sleep disorder or other previously approved uses.
Cephalon, whose shares fell nearly 2 percent, said it will request a re-examination of the agency's assessment.
Analysts said any damage from new Provigil restrictions in Europe should be limited.
The 'recommendation to restrict the use of Provigil in Europe will have a minimal impact on earnings,' Louise Chen, an analyst for Collins Stewart, said in a research note.
Robert W Baird analyst Thomas Russo said he still expects Cephalon to raise its full year forecast when it reports second-quarter earnings next week due to growth of the cancer drug Treanda and U.S. price increases on Provigil.
A review of the drug was initiated by European regulators over a number of safety concerns related to psychiatric disorders, skin and subcutaneous tissue reactions as well as significant off-label use and potential for abuse, the agency said.
On the basis of the available data the agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the drug only outweighs the risks in the treatment of narcolepsy, a chronic sleep disorder characterized by excessive daytime sleepiness.
Narcolepsy was the original use for which Provigil was approved.
For all other uses European officials said safety risks outweighed evidence of clinical efficacy.
The CHMP also identified particular cardiovascular risks with modafinil and recommended that it not be prescribed to patients with uncontrolled high blood pressure or irregular heart rhythms.
'Modafinil has been used safely and effectively for its licensed indications in Europe for many years and we believe the risk/benefit profile in all approved indications is positive,' Cephalon spokeswoman Candace Steele Flippin said.
Modafinil is currently licensed in 21 countries in Europe.
Cephalon shares closed down $1.14, or 1.9 percent, at $59.89 on Nasdaq.
(Reporting by Bill Berkrot, editing Bernard Orr and Carol Bishopric) Keywords: CEPHALON/EUROPE (bill.berkrot@thomsonreuters.com; +1 646 223-6030; Reuters Messaging: bill.berkrot.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.