Psychiatry - July 2008 - (Page 16)

Psych Rx US PANEL REJECTS STRONG EPILEPSY DRUG WARNING BELTSVILLE, MD—Reuters— Antiseizure drugs for treating epilepsy carry an increased risk of suicidal thoughts and behavior, but not enough to warrant a black box warning, a US advisory panel concluded recently. Members of the Food and Drug Administration’s (FDA) panel of outside experts rejected the agency’s proposed caution, expressing concern that a strong warning could scare epilepsy patients from being treated with effective drugs. “We need to be very careful about scaring the patients into not taking their drugs,” said panelist Rochelle Caplan, a professor of psychiatry at the University of California in Los Angeles. The FDA, which sought the panel’s advice, will make the final decision. The agency usually follows the advice of its advisory panels, but could still implement the boxed warning. Agency officials said their analysis of available data pointed to greater suicidal complications in patients taking nearly a dozen epilepsy medications, including Pfizer Inc.’s Lyrica and Neurontin, GlaxoSmithKline Plc.’s Lamictal, Johnson & Johnson’s Topamax, and UCB Inc.’s Keppra, among others. The medications brought in more than $10 billion in 2007 sales, according to healthcare information company IMS Health. Some epilepsy drugs already carry cautions about possible suicide, and officials from Glaxo said they agreed with the FDA’s findings. But Pfizer argued its products showed no such risk and should be exempt from a black box warning. 16 Psychiatry 2008 [JULY] The advisers said all epilepsy medications should include some warning about possible suicide, but not a black box. “It feels like taking a canon to an issue where we don’t really have a clear, definitive idea about the most appropriate action to take,” said panelist Daniel Pine, head of child research at the the National Institute of Mental Health. Similar boxed warnings have been added in recent years to drugs for depression. Some panel members expressed concerns about the effect they had on patients, noting that antidepressant prescriptions have declined. “What we saw was a real scare factor,” said Gail Griffith, a consumer representative on the panel. But unlike antidepressants, data shows epilepsy drugs are clearly effective, the panelists said. FDA officials said it was too early to see what impact the depression drug warnings had on suicides but said boxed warnings are meant draw attention to risks, not deter use. “It doesn’t mean don’t use this drug. It means pay attention,” said Robert Temple, who oversees one of the FDA’s drug evaluation offices. After the meeting, FDA officials said they would discuss the panel'’s advice and expected to make a decision soon. Pfizer said it was glad the panel rejected the black box warning and it would work with the FDA on any label changes. chronic insomnia met its main goal and significantly improved sleep in adult patients, sending the company’s shares up 18 percent. The primary endpoint of the study evaluated the immediate and short-term ability of the drug, tasimelteon, to improve sleep onset. The four-week trial evaluated 322 patients with chronic primary insomnia. It tested 20mg or 50mg doses of tasimelteon against a dummy drug, the biopharmaceutical company said in a statement. Additional study results showed tasimelteon achieved a number of statistically significant improvements on sleep maintenance parameters during the portion of the night in which the patients studied suffered the greatest impairment, the company said. PREPARED STUDY DEMONSTRATES REQUIPMODUTAB IS A HIGHLY EFFECTIVE TREATMENT IN THE MANAGEMENT OF PARKINSON’S DISEASE CHICAGO—New data presented recently at the 12th International Congress of Parkinson’s Disease and Movement Disorders prove that ropinirole is a highly effective molecule in managing Parkinson’s disease (PD). Results from the PREPARED study confirm that Requip-Modutab* (ropinirole prolonged release tablets) offers a highly effective and more simplified treatment regimen compared to ropinirole three-times daily, by providing continuous delivery of ropinirole day and night from a single daily dose. Professor Stocchi, lead trial investigator and Professor of Neurology, IRCCS San Raffaele, Rome, Italy, commented, “For PD patients, continuous control of symptoms throughout the day and 16 VANDA SAYS INSOMNIA DRUG TRIAL MEETS MAIN GOAL BANGALORE (Reuters)—Vanda Pharmaceuticals Inc. said a latestage trial of its drug for treating

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Psychiatry - July 2008 Editor's Message Editorial Advisory Board Contents PsychRx Letters to the Editor Reliability of Diagnoses: Do Psychiatrists Use Structured Interviews In Real Clinical Settings? Trend Watch: Use of Atypical Antipsychotics in the Elderly Review: The Struggle for Mental Healthcare in New Orleans-One Case at a Time Psychotherapy Rounds: Psychotherapeutic and Adjuntive Pharmacologic Approaches to Treating Posttraumatic Stress Disorder Original Research: Baseline Dissociation and Prospective Success in Special Forces Assessment and Selection Commentary: Performance-Enhancing Drugs: Where Should the Line Be Drawn and By Whom? Commentary: Psychiatric Diagnosis and the Pathlogist's View of Schizophrenia Journal Watch Classified Advertising Information for Authors

Psychiatry - July 2008

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