April 22, 2005
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EQUETRO(TM) Now Available for Treatment of Manic and Mixed ...
drugs for bipolar disorder
suspect medicated for bipolar disorder
Shire's EQUETRO(TM) Now Available for Treatment of Manic and Mixed Episodes in Bipolar Disorder.
BASINGSTOKE, England and PHILADELPHIA, April 19 /PRNewswire-FirstCall/ -- Shire Pharmaceuticals Group plc announced today that EQUETRO(TM) (carbamazepine extended-release capsules), the only carbamazepine formulation proven effective for patients with Bipolar Disorder, is now available in the United States.
"The availability of carbamazepine extended-release capsules is a significant milestone in bipolar disorder therapy," said Richard H. Weisler, M.D., Adjunct Professor of Psychiatry at University of North Carolina at Chapel Hill School of Medicine, Adjunct Assistant Professor of Psychiatry and Behavioral Sciences at Duke University Medical Center, and primary investigator of two carbamazepine extended-release capsule clinical trials. "A lot of patients have trouble responding to bipolar medications, so a new treatment option means we can reach more people who suffer from bipolar disorder and help them restore balance in their lives."
Bipolar disorder causes unusual changes in mood - including overly "high" and/or irritable symptoms ("manic episodes"), and symptoms of depression. Some patients experience both manic and depressed symptoms at the same time ("mixed episodes").
EQUETRO has received FDA approval for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. EQUETRO has been shown to significantly reduce manic symptoms in bipolar patients with manic and mixed episodes. In clinical trials,* patients treated with EQUETRO demonstrated a low incidence of clinically significant weight gain. The unique three-bead extended release delivery system of EQUETRO provides patients with smooth carbamazepine levels, and convenient administration. Patients take EQUETRO in twice-daily doses, which can be taken with or without food, and capsules may be opened and sprinkled onto soft food.
"Bipolar Disorder is a serious and debilitating psychological disorder that not only seriously affects patients, but also their family members and friends," said Matthew Emmens, Chief Executive of Shire. "We are pleased to bring this new choice of treatment to patients and hope that EQUETRO will help them to restore balance in their lives and improve quality of life."
Bipolar Disorder is one of the six leading mental disorders worldwide, according to the World Health Organization. More than two million American adults or about 1 percent of the population age 18 and older in any given year, are affected with Bipolar Disorder, also known as manic depression. The disorder is often not recognized as an illness, and as a result people may suffer for years before they are properly diagnosed and treated.
About Bipolar Disorder
Bipolar Disorder is characterized by episodes of mania and depression, with periods of normal mood in between. The disorder can have devastating effects on an individual's life, although proper diagnosis and early treatment can usually alter the course of the illness.
Because of the severity of the illness, bipolar disorder is disruptive to patients, their families, friends and colleagues and can damage relationships, cause poor job or school performance and suicide. Although bipolar disorder is not curable, it is treatable and recovery is possible. Early diagnosis combined with drug therapy is key to optimal treatment.
EQUETRO(TM) contains carbamazepine. Please ensure patient is not taking any other form of carbamazepine.
The most frequently reported adverse events are dizziness, drowsiness, unsteadiness, nausea and vomiting. Initiating therapy at the lowest possible effective dose can minimize adverse events. Reports of transient or persistent decreased platelet or white blood cell count are not uncommon in association with the use of carbamazepine. Although the vast majority of cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis, complete pretreatment hematological testing should be obtained as a baseline. Patients should be monitored and discontinuation of the drug should be considered if any evidence of bone marrow depression occurs.
Because the possibility of a suicide attempt is inherent in bipolar disorder, close supervision of high-risk patients should accompany drug therapy.
EQUETRO was approved by the Food & Drug Administration on December 10, 2004 for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. It is available in 100 milligram (mg), 200 mg and 300 mg dosage strengths. EQUETRO has a formulation patent that runs until 2011 and will have three years market exclusivity under the US Hatch-Waxman Act.
Notes to editors
EQUETRO(TM) is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder.
*An analysis of pooled data from two nearly identically designed, three- week, double-blind, placebo-controlled phase III trials of EQUETRO monotherapy in patients initially requiring hospitalization. The trials involved 443 patients aged 18 to 76 with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV(R)) diagnosis of bipolar disorder (current episode manic or mixed) who were randomized to double-blind treatment with either EQUETRO or placebo.
The pooled analysis revealed that by the end of the trials, EQUETRO patients, both manic and mixed, experienced significant reductions in Young Mania Rating Scale total scores as well as significant improvements in Clinical Global Impression-Severity and Clinical Global Impression-Improvement scores. Investigators measured the safety and tolerability of EQUETRO by measuring participants' weight, blood glucose, cholesterol and interval between heartbeats, as well as adverse event monitoring. Dr. Weisler reported the pooled data analysis Nov. 18, 2004 at the 17th annual U.S. Psychiatric and Mental Health Congress in San Diego, California.
Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.
For further information on Shire, please visit the Company's website: http://www.shire.com/
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward- looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit & Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to Health Canada's suspension of ADDERALL XR sales in Canada and the expected product approval dates of methylphenidate transdermal system (MTS) (ADHD), SPD503 (ADHD), SPD 465 (ADHD), SPD 476 (ulcerative colitis), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Agency in the United States, Shire's ability to secure new products for development, and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2004.
COPYRIGHT 2005 PR Newswire Association LLC
Research and Markets: In US, It Is Estimated 22.1% of Adults Suffer From a Diagnosable Psychiatric Disorder.
DUBLIN, Ireland, April 19 /PRNewswire/ -- Research and Markets (http://www.researchandmarkets.com/reports/c16047 ) has announced the addition of Psychiatric Drugs: New Developments and Market Analysis by Drug Class and Clinical Indication to their offering.
In the U.S. alone, it is estimated that 22.1% of adults ages 18 and older (about 45 million) suffer from a diagnosable psychiatric (or mental) disorder.
Pharmacologic treatment of psychiatric indications is evolving, as the number of new compounds in development for these indications continues to grow, enabled by basic neuroscience research and pharmaceutical R&D efforts that are broad and deep. During the last two decades many new drugs for psychiatric indications have been introduced, paradigm shifts in treatment of major disorders have occurred, and huge and expanding pharmaceutical markets have emerged.
Because of the great cross-over of psych drug classes into many different clinical applications, the Report is broken out into two major sections - drug classes and clinical markets. The Report reviews drugs in the pipeline and provides a sophisticated analysis of changing clinical practices, market dynamics, and informed projections. This Report provides a large database of important classes of psychiatric drugs in development and the multiple indications for which they will be used. In addition, the Report includes a sophisticated analysis of clinical trends (such as and combination drug therapy) and market dynamics.
- Create atypical antipsychotics for bipolar and other indications, which account for far greater sales than the schizophrenia indication
- Produce antiepileptic drugs for bipolar, neuropathic pain, and other indications, which account for far greater sales than epilepsy indications
- Develop cognitive / memory enhancing compounds for Alzheimer's disease and mild cognitive impairment, a potentially huge new market
- Wake-promoting drugs for narcolepsy are in development for and/or obtaining approvals for stimulant-type indications (including ADHD) and have created an entirely new indication - excessive daytime sleepiness - with huge market potential
Key Reasons to Read This Report
- Gain comprehensive insight across the various drug classes with an overview of the ten major psychiatric drugs including tables of drugs in development and in clinical trials, important R&D trends, critical upcoming developments, markets, and market drivers.
- Learn about clinical market trends via a thorough analysis of the nine major psychiatric indications including basic definitions, etiology, prevalence estimates, and current therapies.
- Look inside 58 companies who are involved in psychiatric drug development from small companies developing only a few drugs to major pharmaceutical companies developing a dozen to more than 20 drugs for psychiatric indications.
This Report Answers These Crucial Industry Questions
- What is the status of new drugs in development by drug class and clinical indication?
- Which drugs are promising for which (potentially multiple) clinical indications?
- How are multiple indications having an impact on new drug development and pursuit of new, multiple market opportunities?
- What are the new and upcoming compounds with novel mechanisms of action and new, potentially, first-in-class compounds, and how soon will they have a clinical market impact?
- Will new compounds sustain the remarkable growth experienced by psychiatric drugs during the last two decades, or is market stagnation or decline an inevitable result of generic competition?
- What are the potential applications and market opportunities for psychiatric drugs by drug class?
- What drugs are competing for the same indications?
- In which clinical markets are drugs from disparate drug classes having a current impact and how will these markets change during the next 5 to 10 years?
COPYRIGHT 2005 PR Newswire Association LLC
Sick lawyer who cheated clients to get medical care in specialized setting.
Sarasota Herald Tribune; 4/19/2005
Byline: Tom Lyons
Donald Pervis is a lawyer gone bad, and justice has finally been served.
His ads listed phone numbers in Sarasota, Venice and Bradenton, but never mentioned his hobby: day trading on the Internet.
That obsession was losing him lots of money, so Pervis started ripping off his clients.
As I've written in two previous columns, the first in 2003 before I ever thought Pervis would face criminal charges, most clients took a long time to suspect they were being robbed. Mostly they were car accident victims awaiting insurance settlements to pay medical bills. Pervis repeatedly made settlement deals and collected from insurance companies. He told his clients their medical bills were being paid. Some clients also had money coming to them.
But the bills weren't paid and checks to clients weren't in the mail. Pervis was pilfering his trust account to do more day trades he desperately hoped would win back all the money he had already lost on other bad trades, as his lawyer, Martin Burzynski, acknowledged in court on Friday.
Pervis squandered his own money as well as that of at least 16 clients who lost a total of more than $300,000, Burzynski said.
The Florida Bar eventually reimbursed many victimized clients. But there is a cap on what the Bar will pay any one victim, usually $50,000, and some had lost more. So despite $188,576 in reimbursements, some clients were still out a total of more than $116,000.
Pervis was sentenced Friday after a guilty plea to the charge of scheming to defraud.
That's a first-degree felony. By state statute, it is punishable by up to 30 years in prison, but not really. Sentencing guidelines for a first-time offender like Pervis didn't call for a day in prison.
And Burzynski argued that Pervis has too many serious health problems for prison. He asked for house arrest or probation.
After all, Pervis, 59, sleeps with an oxygen tank, has had a heart attack and heart surgery, and has diabetes, vision loss, memory problems and headaches. Oh, and a court-appointed psychologist recently diagnosed a touch of bipolar disorder.
Some of those factors surely contributed to the man's bad decisions, Burzynski told me. He said Pervis pleaded guilty to spare the victims a more drawn-out process.
So, do you feel guilty about ever thinking the poor sick guy should be locked up?
Well, you shouldn't. That guy was a predator ruled by greed. He tried to get rich the easy way, and violated the trust placed in him as a professional by stealing from those he was sworn to serve.
And if you hate to put a sick guy in prison, consider this: Prosecutor Kate Wallace got unexpected help when she cross-examined a doctor who testified for the defense. In the enforced regimentation of a prison facility for inmates with medical problems, he said, Pervis might fare better than supervising himself.
I'm happy to say Judge Andrew Owens went well over the guideline recommendation. He gave Pervis five years in prison, as Wallace asked, followed by much probation.
With credit for time served and such, Pervis should be out in three and a half years.
Or maybe not. I almost forgot: Pervis has another charge pending. Prosecutors say he was part of an investment scam that defrauded many members of the church where he was a trusted elder.
If so, I'm sure it was bad health making him do it. Haven't you noticed that feeling poorly always gives a guy the urge to organize schemes to steal from everyone who trusts him?
I'm glad the state has a treatment for it.
COPYRIGHT 2005 Sarasota Herald-Tribune
Supervisors to hear mental health issue.
North County Times (Escondido, California) (via Knight-Ridder/Tribune Business News); 4/19/2005
Byline: Gig Conaughton
Apr. 19--SAN DIEGO ---- Ignoring objections from their own mental-health advisory board, county officials have already started turning over mental health services in North County to a private company to shave an estimated $427,000 a year off their system's $14.3 million annual cost.
Critics said Monday that the relatively meager savings did not justify turning county services over to a private company, which they worried would hurt mental health patients by cutting services and hiring cheaper "interns" to replace clinicians.
County officials rejected those arguments Monday and said no services would be cut.
"No one is going to get hurt," said Alfredo Aguirre, director of the county's mental health system.
Supervisors, meanwhile, are scheduled to vote on the changeover today.
Aguirre suggested that board approval was considered mostly a formality, required because the change would cut five county jobs and move 59 other workers to new departments. He said the transition had already started.
But members of the advisory panel and mental health advocates said they would ask the board today to reconsider.
Officials from North County's chapter of the National Alliance for the Mentally Ill -- a nonprofit that advocates for the mentally ill -- said a company striving for profit would cut services designed to keep mentally ill patients functioning normally.
In particular, the group said they feared the changeover would end the county's current "triaging" of mental health patients who come to North County's Oceanside and Escondido offices for help.
They said the result could be more poor, mentally ill patients ending up in local jails and emergency rooms.
Paul Cumming, a member of the county's Mental Health Advisory Board -- which is comprised of health officials, mental-health clients, psychiatrists and others -- agreed with the alliance's concerns.
Cumming, 49, who was diagnosed with bipolar disorder when he was in his 20s, said the county's program now has personnel on staff to immediately help mental health patients when they come in with a problem or episode.
Aguirre said Mental Health Services Inc. -- the company that would take over in North County -- would not cut services, but would slightly change the triage system.
Aguirre said the company would promise to see anyone walking in their doors within 72 hours.
But Cumming and others said sending already-fragile mental health patients away when they come to get help would increase what he called "spin-outs" -- mental health patients suffering setbacks that could include visits to emergency rooms or acting out and ending up in jail.
"If they spin out, it's always expensive," Cumming said. "It's never cheap. They're just asking for trouble."
At the same time, Cumming said advisory board members didn't think the cost savings the county would get by contracting with Mental Health Services Inc. in North County was enough to justify taking the risk.
Aguirre said Mental Health Services Inc. submitted a bid to handle the county's mental health patient caseload in Oceanside -- one of North County's two county offices -- for just under $2 million in 2005-06.
Aguirre said that was $1.5 million less than what the county did the job for last year.
However, Aguirre also said that it was only $85,000 a year less than what county mental health officials say they could do the job for next year after reviewing, and cutting, costs.
Likewise, Mental Health Services Inc. said they could handle the county's Escondido caseload for $1.7 million a year, much less than the county's $2.8 million cost last year.
But again, the private company's bid is only $262,000 a year less than what county officials say they can do the job for themselves next year.
In any case, Cumming and Aguirre said the county stands to shave millions off its mental health costs next year.
Aguirre said that's because county supervisors voted last June to have its seven, regional mental health offices compete against private companies to see who could do the jobs more efficiently.
Five of the seven county offices said they could do the job for less than competing private companies and will continue to provide services.
And Aguirre said with Mental Health Services Inc. taking over in Oceanside and Escondido, the county expects to cut last year's $21.9 million mental health services budget by $7.6 million -- or 34 percent -- in 2005-06, down to $14.3 million.
"That's significant savings," Aguirre said.
But Cumming -- who said Mental Health Services Inc. was a "fine company -- and representatives from the North County mental health alliance said the county could save almost all of that $7.6 million a year without contracting out to private business in North County.
Because of that, those officials said they hope to convince county supervisors not to give the contract to Mental Health Services Inc.
"It's an insignificant savings in the long run," Cumming said.
COPYRIGHT 2005 North County Times
RESOURCES FOR BIPOLAR DISORDERS.
The Cincinnati Post (Cincinnati, OH); 4/19/2005
Q.: I am trying to learn more about lifestyle issues that accompany the treatment regime for a person diagnosed with bipolar disorder.
Do they have sleep disorders and weight gain brought on by the medication? If yes, how do they cope with these two areas?
Are there any online references that I can learn more about these two topics? books? Thanks,
A.: Thank you for your excellent questions regarding "lifestyle issues that accompany the treatment regime for a person diagnosed with bipolar disorder."
With respect to your question, "Do they have sleep disorders and weight gain brought on by the medication?" and "If yes, how do they cope with these two areas?":
Yes, children, teens and adults who have bipolar disorder frequently report sleep problems associated with mania (a decreased need for sleep), depression (problems falling/staying asleep, waking-up too early or sleeping too much) and as a side-effect of the medication. Although weight-gain is not a symptom of mania, it can be a symptom of depression. It can also be a side-effect of medication. The key question to answer is did these problems begin with the medication or were they occurring even before the onset of meds?
Regarding coping with sleep problems and weight-gain: If these problems are due to the medication, talk to the prescribing M.D. about them and ask him/her about ways to help.
Sometimes a change in the time meds are taken, the dose, the type of medication or even the addition of another medication can reduce side-effects. If these problems are not due to the medication, seek the assistance of a therapist trained to treat mood disorders of childhood, adolescence or adulthood.
Regarding "online references that I can learn more about these two topics? books?" -- take a look at the following.
For Adults with Bipolar Disorder:
* Depressive & Bipolar Support Alliance (DBSA) 1-800-826-3632, local chapter: 614-792-9749 www.dbsalliance.org;
* "The Bipolar Survival Guide: What You and Your Family Need to Know," by D.J. Miklowitz;
* For Children/Teens with Bipolar Disorder: Child & Adolescent Bipolar Foundation (CABF) 1-847-256-8525. www.bpkids.org or www.cabf.org;
* "Raising a Moody Child: How to Cope with Depression and Bipolar Disorder," M.A. Fristad & J.S. Goldberg-Arnold;
* "The Ups and Downs of Raising a Bipolar Child," J. Lederman & C. Fink.
I hope my answers are helpful. Best wishes!
Today's answer is from Nicholas Lofthouse, Ph.D., Clinical Assistant Professor of Psychiatry, Child and Adolescent Psychiatry, Department of Psychiatry, College of Medicine and Public Health, Ohio State University.
NetWellness, a collaboration of the University of Cincinnati, Ohio State University and Case Western Reserve University, is a consumer health information Web site. You can ask your questions through the site, www.netwellness.org.
COPYRIGHT 2005 The Cincinnati Post. All rights reserved. Reproduced with the permission of the Dialog Corporation by Gale Group.