Month: November 2013

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Technology capable of reaching deeper brain areas may provide relief of symptoms for patients resistant to medication

Cincinnati, Ohio – For more than four million Americans in the United States, the symptoms of depression are not relieved by the use of antidepressant medications. This class of depression falls into one of two categories, treatment resistant depression (TRD)or treatment intolerant depression (TID). The TRD group often tries and fails several different types of medications – either alone or in combination – while the TID group has medication side effects so debilitating that they cannot tolerate the treatment.

For these patients, an entirely new type of treatment is being studied at the Lindner Center of HOPE, led by John Hawkins, M.D., chief of psychiatry at the center. The technology, called multicoil repetitive transcranial magnetic stimulation (rTMS) or simply TMS, is a non-medication, non-systemic and non-invasive approach to treating depression.

“TMS offers patients that either do not respond to, or cannot tolerate medication, a new treatment option,” said Dr. Hawkins. “Our clinic is currently studying a new approach to this technology and we are hopeful that it will provide relief for these patients that have been suffering from depression in some cases for several years.”

Depression is thought to occur because of less than optimalchemical activity in the brain. TheTMS treatment currently under study by Dr. Hawkins and his team uses multiple magnetic fields, generated by coils placed on a patient’s scalp, to stimulate specific brain regions both on the surface and in deeper regions of the brain. This research is important in understanding whether TMS treatment restores normal brain chemical activity, thereby reducing the symptoms of depression. To date, more than 100 patients have been studied using this approach without the occurrence of serious side effects related to the device.

Depression is a mental disorder characterized by loss of interest or pleasure in activities that were previously enjoyable, a decrease in energy, feelings of low self-worth, disturbed sleep or appetite and difficultyin concentrating.1 Depression often comes with symptoms of anxiety and these problems can become chronic, substantially impairing the ability of an individual to take care of everyday responsibilities.  On a global scale, depression affects more than 350 million people and is the leading cause of disability worldwide.2

To find out more information about the TMS study at Lindner Center of HOPE contact 513-536-0712 or visit http://clinicaltrials.gov/ct2/show/NCT01909232.

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1Marcus, M. et al. Depression: A Global Public Health Concern. World Health Organization 2012, Department of Mental Health and Substance Abuse. http://www.who.int/mental_health/management/depression/who_paper_depression_wfmh_2012.pdf.Accessed 04.6.2013.

2Marcus, M. et al.

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Lindner Center of HOPE today was named Top Performer on Key Quality Measures® by The Joint Commission, the leading accreditor of health care organizations in America. Lindner Center of HOPE was recognized by The Joint Commission for exemplary performance in using evidence-based clinical processes that are shown to improve care for certain conditions. The clinical processes focus on care for heart attack, pneumonia, surgery, children’s asthma, stroke and venous thromboembolism , as well as inpatient psychiatric services. New this year is a category for immunization for pneumonia and influenza.

Lindner Center of HOPE is one of 1,099 hospitals in the U.S. earning the distinction of Top Performer on Key Quality Measures for attaining and sustaining excellence in accountability measure performance. Lindner Center of HOPE was recognized for its achievement on the following measure sets:  Hospital- Based Inpatient Psychiatric Services. The ratings are based on an aggregation of accountability measure data reported to The Joint Commission during the 2012 calendar year. The list of Top Performer organizations increased by 77 percent from last year and it represents 33 percent of all Joint Commission-accredited hospitals reporting accountability measure performance data for 2012.

Lindner Center of HOPE and each of the hospitals that were named as a Top Performer on Key Quality Measures must:  1) achieve cumulative performance of 95 percent or above across all reported accountability measures; 2) achieve performance of 95 percent or above on each and every reported accountability measure where there are at least 30 denominator cases; and 3) have at least one core measure set that has a composite rate of 95 percent or above, and within that measure set all applicable individual accountability measure have a performance rate of 95 percent or above. A 95 percent score means a hospital provided an evidence-based practice 95 times out of 100 opportunities. Each accountability measure represents an evidence-based practice.

“Lindner Center of HOPE and all the Top Performer hospitals have demonstrated an exceptional commitment to quality improvement and they should be proud of their achievement,” says Mark R. Chassin, M.D., FACP, M.P.P., M.P.H., president and chief executive officer, The Joint Commission. “We have much to celebrate this year. Nearly half of our accredited hospitals have attained or nearly attained the Top Performer distinctions. This truly shows that we are approaching a tipping point in the hospital quality performance that will directly contribute to better health outcomes for patients.”

“We understand that what matters most to patients at Lindner Center of HOPE is safe, effective mental health care. That’s why Lindner Center of HOPE has made a commitment to accreditation and to positive patient outcomes through evidence-based care processes. Lindner Center of HOPE is proud to receive this distinction of being a Joint Commission Top Performer on Key Quality Measures, says Dr. Paul Keck, President and CEO.

In addition to being included in The Joint Commission’s “Improving America’s Hospitals” annual report, Lindner Center of HOPE will be recognized on The Joint Commission’s Quality check website, www.qualitycheck.org. The Top Performer program will be featured in the December issues of The Joint Commission Perspectives and The Source.

Lindner Center of HOPE  provides excellent, patient-centered, scientifically-advanced care for individuals suffering with mental illness. A state-of-the-science, mental health center and charter member of the National Network of Depression Centers, the Center provides psychiatric hospitalization and partial hospitalization for individuals age 12-years-old and older, outpatient services for all ages, diagnostic and short-term residential services for adults, intensive outpatient program for substance abuse and co-occurring disorders for adults and research. The Center is enhanced by its partnership with UC Health as its clinicians are ranked among the best providers locally, nationally and internationally. Together Lindner Center of HOPE and UC Health offer a true system of mental health care in the Greater Cincinnati area and across the country. The Center is also affiliated with the University of Cincinnati (UC) College of Medicine.

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Each year, millions of Americans find themselves caught in a cycle of addiction to alcohol, drugs, gambling, or other substances/ behavior.  They must struggle daily with the effort to become and remain free of the drugs or behaviors to which they feel uncontrollably drawn.

Affected individuals are diagnosed on the basis of the particular substance or activity to which they are addicted.  However, individuals with any type of addictive disorder may exhibit related symptoms, and both causes and treatment are similar.

The Nature of Addiction

An addictive disorder, as opposed to temporary reliance on a particular substance or behavior, can be distinguished by several distinct symptoms:

Tolerance. Over time, an individual requires increasing amounts of the preferred substance/behavior to achieve the same physical or psychological effects.

Withdrawal. When an individual tries to curb the addiction, withdrawal symptoms such as anxiety, rapid heartbeat, sweating, etc., will occur.

Lack of control. The individual has extreme difficulty cutting back or controlling the addictive behavior, even when aware of negative consequences.

Preoccupation. Cravings for the desired substance or behavior are constant.  Increasing amounts of time are spent planning, participating in, and then recovering from the addictive behavior, with employment and relationships often threatened.

Causes of Addiction

Are addicts “born that way,” or do they develop addictive disorders due to environmental factors?  In this nature vs. nurture debate, both answers may be true. Psychological, genetic, environmental, and other factors that determine a particular individual’s likelihood of developing an addiction may be interrelated.

Biological factors.  Studies have shown that the likelihood of twins developing the same addiction is 50-70%, and familial rates of such addictions as alcoholism are significant. Other research has pointed to such biological factors as abnormal dopamine levels influencing addictive behavior.

Psychological factors.  Is there such a thing as an addictive personality? While no such diagnostic code exists, many experts believe that certain personality traits make individuals more vulnerable to addiction.  They include: sensation seeking, impulsivity, poor coping skills, anxiety or depression, insecurity, and feelings of social alienation.

Environmental factors.  Stress may the factor that figuratively pulls the addiction trigger in an individual who is biologically or psychologically prone to develop one. A history of trauma, for example, is frequently found in individuals who develop an addiction, particularly any type of severe stress in childhood.  Physical or sexual abuse also increases the risk of developing an addictive disorder.

Treatment of Addiction

Numerous treatment approaches have developed that provide benefit to individuals in acute stages of addiction, and a robust recovery movement provides ongoing support and management of the illness. Treatment modalities include:

Medical approaches.  Depending upon the nature of the addiction, an individual may benefit from medical detoxification and an inpatient rehabilitation program.  While the use of medication is often discouraged, short-term use of medication is necessary in some instances.

Psychotherapy.  Many contemporary forms of “talk therapy” have demonstrated positive results in individuals with addiction, including the following:

  • Cognitive behavioral therapy;
  • Motivational enhancement therapy;
  • Dialectical behavioral therapy;
  • Relapse prevention therapy.

These therapies teach individuals better coping skills, including recognition of triggers to addictive behavior, stress reduction, relapse avoidance, and impulse control.

Psychotherapy may be conducted in an individual or group setting. Family therapy is often encouraged in order to reduce enabling of addictive behaviors, as well as to heal broken relationships.

Community and family supports. Peer support is a cornerstone of most successful recovery programs. Recovering individuals find ongoing support through a variety of community organizations such as Alcoholics Anonymous (AA), Narcotics Anonymous (NA), or similar groups.  Many support groups are based on the twelve-step recovery model first established for AA.

In addition to counseling, families may benefit from support groups such as Al-Anon for assistance in dealing with a loved one’s addictive behavior.

Addictive disorders can be daunting, but with proper treatment and support, individuals can experience recovery and return to full function in their homes and communities.

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Positive Top-line Results Shown for Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) in Adults with Binge Eating Disorder

Shire Plans to Submit a Supplemental New Drug Application (sNDA) by Q3 2014

05 November 2013 – Shire plc (LSE: SHP, NASDAQ: SHPG) announces positive top-line results from two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) versus placebo in adults with binge eating disorder (BED). In both studies Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis (p-value <0.001) of the change from baseline at weeks 11 to 12 in terms of number of binge days per week. The safety for Vyvanse in these two studies appears to be generally consistent with the known profile established in studies in adults with Attention-Deficit/Hyperactivity Disorder (ADHD). The Company is reporting the data sooner than originally anticipated because of faster than expected completion of both studies.

“We are extremely pleased with these results, and will be working expeditiously to submit an application to the U.S. Food and Drug Administration for a new indication of BED for Vyvanse, already well established for its efficacy and safety in ADHD,” said Flemming Ornskov, M.D., Chief Executive Officer, Shire. “BED is a condition for which there is no currently approved pharmacologic treatment and yet there is significant unmet patient need, as was demonstrated with the faster than expected enrollment of participants in our clinical trial program. Our development of Vyvanse for BED also aligns well with Shire’s growth strategy of developing innovative treatments to address significant unmet patient needs.”

In addition to the positive top-line primary results, both studies showed statistically significant (p-value <0.001) and consistent treatment effects for Vyvanse across the key secondary efficacy endpoints that have been analyzed thus far in the top-line data. These include the Clinical Global Impressions – Global Improvement (CGI-I), 4-week binge cessation, percent change from baseline in body weight, and change from baseline in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE). Additional analyses continue for other secondary endpoints. Shire anticipates presenting the efficacy and safety data from both studies at a major scientific meeting in 2014. The company plans to file for FDA regulatory approval of Vyvanse for the treatment of BED in adults (ages 18 to 55) by Q3 2014.

Vyvanse is a prescription medicine currently only approved for the treatment of ADHD in the United States, Canada, Australia, several European countries (trade name: Elvanse®/Tyvense®) and Brazil (trade name: Venvanse™). Vyvanse should only be used in accordance with locally approved prescribing information.

CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

BED has a lifetime prevalence of 2.8 percent in adults in the United States, and is characterized by recurring episodes of binge eating, feeling out of control while binging, and feeling guilt and shame afterward. It is formally recognized as a distinct psychiatric disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5™).

“Binge eating disorder is an important public health problem that is under-recognized, and causes great distress for patients,” said Susan L. McElroy, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine; and principal investigator of both studies. “Increased awareness of binge eating disorder among the medical community is greatly needed, as are novel treatment strategies for individuals suffering from this often secretive disorder.”

ABOUT THE BED STUDIES

Each of the two identically designed pivotal Phase 3, multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-optimized studies was designed to assess the safety, efficacy, and tolerability of Vyvanse in patients aged 18 to 55 who met DSM-IV-TR® criteria for a diagnosis of BED. Study SPD489-343 randomized 383 patients and study SPD489-344 randomized 390 patients. Patients were randomized in a 1:1 ratio to Vyvanse or placebo. The primary efficacy endpoint for these studies was defined as the change from baseline to Weeks 11 – 12 (Visit 8) in the number of binge days per week determined by clinical interview based on participant diary data. Vyvanse was statistically superior to placebo on the primary efficacy analysis for both studies.

Safety and tolerability evaluations of Vyvanse included treatment-emergent adverse events (TEAEs), vital signs, weight, and electrocardiograms (ECGs).

The key secondary endpoints analyzed to date included CGI-I, 4-week binge cessation, percent change from baseline in body weight, and change from baseline in Y-BOCS-BE. The CGI-I was dichotomized as improved (including categories of ‘very much improved’ and ‘much improved’) or not improved (other categories excluding ‘not assessed’). The endpoint 4-week cessation of binge eating is defined as no binge episodes for 28 consecutive days prior to the last study visit. The Y-BOCS-BE is a modified version of Yale-Brown Obsessive Compulsive Scale that measures the obsession of binge eating thoughts and compulsiveness of binge eating behaviors. Vyvanse was statistically superior to placebo on the key secondary efficacy endpoints analyzed to date for both studies.

Study SPD489-343

In study SPD489-343 there were 3 patients treated with Vyvanse who reported serious adverse events (SAEs); 2 patients treated with placebo reported SAEs. There were 12 patients on Vyvanse who reported treatment-emergent adverse events (TEAEs) that led to study discontinuation; 5 patients on placebo reported TEAEs that led to study discontinuation. The most commonly reported (>=5% of patients) TEAEs in patients taking Vyvanse included dry mouth, insomnia, headache, decreased appetite, nausea, irritability, heart rate increased, anxiety, feeling jittery, constipation, hyperhidrosis.

Study SPD489-344

In study SPD489-344 there was 1 patient treated with Vyvanse who reported a serious adverse event (SAE); 2 patients treated with placebo-reported SAEs. There were 7 patients on Vyvanse reported TEAEs that led to study discontinuation; 4 patients on placebo reported TEAEs that led to study discontinuation. The most commonly reported (>=5% of patients) TEAEs in patients taking Vyvanse included dry mouth, headache, insomnia, fatigue, nausea, diarrhoea, decreased appetite, constipation, feeling jittery, blood pressure increased, and irritability.

There were no deaths in either of the studies.

Further evaluation of the safety information related to vital signs, ECG, clinical laboratory and other safety assessments results is currently underway.

The safety profile for Vyvanse in these two studies, based on top-line data, appears to be generally consistent with the known profile established in studies in adults with ADHD.

The studies consisted of a minimum 2-week screening period, a 12-week treatment phase (4 weeks of dose-optimization and 8 weeks of maintenance), and a follow-up visit 1 week after the last on-treatment visit. During the screening period, eligible patients demonstrated BED of at least moderate severity, defined in the study protocol as at least three or more binge days per week, for each of the 2 weeks prior to baseline, per diary entries. Patients were randomized to Vyvanse or placebo treatment groups. During the dose optimization period, all Vyvanse-treated patients were initiated at the 30-mg dose, and then titrated in 20-mg increments to their optimal dose (either 50 or 70mg).

Patients were excluded if they had a concurrent diagnosis of bulimia nervosa, anorexia nervosa, other psychiatric disorders, or certain medical co-morbidities (e.g., cardiovascular risk, moderate to severe hypertension, diabetes mellitus); a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 18 or more at baseline visit; a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence.

RESEARCH CRITERIA FOR BED DIAGNOSIS

Both clinical trials used the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR®) research criteria for BED. DSM-IV-TR® research criteria for BED, as set forth in Appendix B (Criteria Sets and Axes Provided for Further Study), characterizes the disorder by recurrent episodes of eating unusually large amounts of food in a short period of time (e.g., within a 2-hour period), a sense of lack of control over the act of eating during the episode, and marked distress. BED episodes also are associated with at least three of the following: eating more rapidly than normal; eating until feeling uncomfortably full; eating large amounts of food when not feeling physically hungry; often eating alone because of embarrassment by how much food is being eaten; feeling disgusted with oneself, depressed or guilty after overeating. Binge eating occurs, on average, at least two days a week for six months. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
The recently published DSM-5™ (May 2013) includes BED as a formal Eating Disorder diagnosis. DSM-5™requires that binge eating occurs on average at least once a week for three months.

SHIRE PIPELINE UPDATE

In light of the early availability of top-line data for the BED phase 3 program, Shire has reviewed timelines for two other major phase 3 programs: lifitegrast in Dry Eye Disease and Vyvanse as an adjunctive treatment in Major Depressive Disorder (MDD). The Company now anticipates that top-line data from OPUS 2 for lifitegrast could become available before the end of 2013. The Sonata safety study for lifitegrast is scheduled for completion by mid-2014. The MDD program for Vyvanse is also on track for completion in the first half of 2014.

ABOUT Vyvanse® (lisdexamfetamine dimesylate)

INDICATION

Vyvanse is indicated for the treatment of ADHD in patients ages 6 and above. Efficacy was established in short-term controlled studies in children aged 6 to 17 and in adults. Vyvanse is also approved as a maintenance treatment for patients ages 6 and above with ADHD based on one maintenance study in patients aged 6 to 17 and one maintenance study in adults.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence.

Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

  • Contraindications:
    • Known hypersensitivity to amphetamines or other ingredients in Vyvanse. Anaphylactic reactions, Stevens – Johnson syndrome, angioedema, and urticaria have been observed in postmarketing reports.
    • Concurrent administration of monoamine oxidase inhibitors (MAOI) or administration of Vyvanse within 14 days of the last MAOI dose. Hypertensive crisis can occur.
  • Educate patients about abuse and periodically re-evaluate the need for Vyvanse.
  • Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Prior to treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Vyvanse treatment.
  • CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
  • Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychosis. Clinical evaluation for bipolar disorder is recommended prior to stimulant use.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor weight and height in children during treatment with Vyvanse. Treatment may need to be interrupted in children not growing as expected.
  • Stimulants used to treat ADHD, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes (e.g., numbness, pain, skin color change, or sensitivity to temperature, and rarely ulcerations and/or soft tissue breakdown) is necessary during treatment and may require further evaluation (e.g., referral).
  • The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:
  • Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth and dizziness;
    • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
    • Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety and anorexia.

Please click here for Full Prescribing Information.

For further information please contact:

Investor Relations
Eric Rojas
[email protected]
+1 781 482 0999

Sarah Elton-Farr
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+44 1256 894157

Media
Jessica Mann
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+44 1256 894 280

Gwen Fisher
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+1 484 595 9836

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better lives.

Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.

We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal, Internal Medicine and Regenerative Medicine, and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.

www.shire.com

The Vyvanse®, Elvanse®, Tyvense®, and Venvanse™ marks used in this release are trademarks of Shire plc or companies within the Shire group.

FORWARD – LOOKING STATEMENTS – “SAFEHARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

  • Statements included in this announcement that are not historical facts are forward-looking statements. 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 adversely affected. The risks and uncertainties include, but are not limited to, that:
  • Shire’s products may not be a commercial success;
  • Revenues from ADDERALL XR are subject to generic erosion;
  • The failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire’s products may impact future revenues and earnings;
  • Shire relies on a single source for manufacture of certain of its products and a disruption to the supply chain for those products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis;
  • Shire uses third party manufacturers to manufacture many of its products and is reliant upon third party contractors for certain goods and services, and any inability of these third party manufacturers to manufacture products, or any failure of these third party contractors to provide these goods and services, in each case in accordance with its respective contractual obligations, could adversely affect Shire’s ability to manage its manufacturing processes or to operate its business;
  • The development, approval and manufacturing of Shire’s products is subject to extensive oversight by various regulatory agencies and regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
  • The actions of certain customers could affect Shire ‘s ability to sell or market products profitably and fluctuations in buying or distribution patterns by such customers could adversely impact Shire’s revenues, financial conditions or results of operations;
  • Investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in the distraction of senior management, significant legal costs and the payment of substantial compensation or fines;
  • Adverse outcomes in legal matters and other disputes, including Shire’s ability to obtain, maintain, enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of operations; and other risks and uncertainties detailed from time to time in Shire’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10K.