Next month the Brain Behavior and Research Foundation will host a free webinar on Schizophrenia. The “Meet the Scientist” session will be moderated by Dr. Jeffrey Borenstein of the Brain & Behavior Research Foundation and will feature Dr. Carol Tamminga, Psychiatrist and co-founder of the International Congress on Schizophrenia Research. The session will be held on Tuesday, November 10, from 2-3pm Easter Time, and will feature a Q&A. To learn more about the session or to register, visit the Brain Behavior & Research Foundation website.
FDA Approves ARISTADA™ for Treatment of Schizophrenia
— First Long-Acting Atypical Antipsychotic With Both Once-Monthly and Six-Week Dosing Options —
— Product Features Include Range of Dose Strengths and Multiple Dosing Intervals Designed to Address Individual Patient Needs —
— Company to Host Conference Call at 7:30 a.m. EDT Tomorrow —
DUBLIN–(BUSINESS WIRE)–Oct. 5, 2015– Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA™ (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection. Alkermes is preparing to launch ARISTADA immediately.
This Smart News Release features multimedia. View the full release here:http://www.businesswire.com/news/home/20151005006733/en/
“ARISTADA is a new treatment option designed to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Building on nearly two decades of experience developing innovative medicines for chronic and serious CNS diseases, we are dedicated to helping to improve the lives of patients as well as meeting the needs within the treatment ecosystem of caregivers, physicians, payers and society. We look forward to making ARISTADA available to patients and healthcare providers as quickly as possible.”
ARISTADA’s features, including a range of dose strengths and dosing interval options, are designed to address the individual needs of patients and challenges in the treatment of schizophrenia. As a long-acting injectable medicine, ARISTADA provides patients, clinicians and families the certainty that patients receive medication for this serious brain disorder. Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time1 and help healthcare providers to track patient adherence.2
“Schizophrenia is a serious and debilitating disease where, despite the existence of many medicines, there remains significant unmet medical need and suffering. New treatment options are needed to help patients and their families better manage this illness,” said David Henderson, M.D., Associate Professor of Psychiatry at Massachusetts General Hospital. “Long-acting therapies are rapidly evolving to the forefront of the treatment of schizophrenia as clinicians increasingly recognize the potential benefits of less frequent dosing and consider their use earlier in disease progression.”
The FDA approval of ARISTADA was based on a proven safety and efficacy profile, including data from a randomized, double-blind, placebo-controlled, phase 3 study in 623 patients with schizophrenia. Data from that trial showed that multiple dose strengths of ARISTADA met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12, met the key secondary endpoint and demonstrated significant improvements in schizophrenia symptoms versus placebo. The most common adverse events in the study were insomnia, akathisia and headache. The results of the phase 3 study were published in June 2015 by The Journal of Clinical Psychiatry, a peer-reviewed medical journal.
Alkermes will host a conference call on Tuesday, Oct. 6, 2015, at 7:30 a.m. EDT (12:30 p.m. BST). The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. The conference call will also be webcast on the Investors section of Alkermes’ website at www.alkermes.com. In addition, a replay of the conference call will be available from 9:30 a.m. EDT (2:30 p.m. BST) on Tuesday, Oct. 6, 2015, through5:00 p.m. EDT (10:00 p.m. BST) on Tuesday, Oct. 13, 2015, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.
Excerpt from a Press Release on the Alkermes Investor Website
On Wednesday, October 7, 2015 the National Journal will host a Mental Health Reform forum. The forum, will feature lawmakers, key experts, and stakeholders and answer questions like, “Are expanded behavioral health provisions under the Affordable Care Act being adequately Implemented?”and “How can we protect the rights of the mentally ill and safely integrate them back into their communities?” Admission to the Forum is free and the event will be held at the Newseum on Pennsylvania Avenue in Washington, D.C. To RSVP or get more information please visit the event page on Eventbrite.
Places for People, a St. Louis-based organization that offers outpatient mental health care, is bringing visibility to mental health issues through the “Hear Our Voices” campaign. The purpose of #HearOurVoices is to change perceptions of people living with schizophrenia spectrum disorders and severe persistent mental illness by having people experience the auditory hallucinations experienced by someone with schizophrenia. Here are three ways you can participate:
- Visit http://placesforpeople.org/hear-our-voices and participate in the auditory activity (NOTE: Places for People warns that this activity may not be suitable for people with mental illnesses or vertigo)
- Share your experiences or support by using the #HearOurVoices hashtag on Twitter, Facebook, and other social media sites.
- Challenge your friends and family to participate in the campaign by engaging in the experience or posting to social media.
For more information visit placesforpeople.org.
This week Mount Sinai Hospital and Mount Sinai School of Medicine posted a statement saying that tracking changes in the retina, a part of the eye, may help doctors to track the progression of Schizophrenia and better treat patients with the disorder. People with Schizophrenia commonly experience specific vision problems which has allowed doctors to better predict a Schizophrenia diagnosis in children before symptoms emerge. The most recent study attempts to link Schizophrenia to physical changes in the eye, specifically the retina, finding that abnormal response to light suggest cellular-level differences between the eyes of people unaffected with Schizophrenia and those who are.
Read the full statement here.
A study published earlier this month linked Omega 3-s with the decrease in symptoms and slower progression of psychotic disorders including schizophrenia. The study followed 81 adolescents and young adults aged 13 to 25 who were at ultra-high risk of psychotic disorders; the study participants received fish oil capsules containing Omega-3 fatty acid daily for 12 weeks. After the trial period the rate of transition to psychosis was reduced and participants also experienced improvement in their symptoms and functioning. Follow ups at seven years also showed reduced rates of conversion to psychosis as well as lower scores on Positive and Negative Syndrome Scale measures, than others who had not received the medication. There is more research needed to confirm the results of this study, but as stated by William Carpenter, M.D. a professor of psychiatry and pharmacology, “If the results are valid, it will represent the most important advance related to psychosis treatment and prevention since chlorpromazine was introduced over 60 years ago.”
Click Here to read more about the study.
(ARLINGTON, VIRGINIA) Senator John Cornyn (R-TX) today introduced sweeping criminal justice reform legislation aimed at reducing mass incarceration of people with mental illness.
The Mental Health and Safe Communities Act would expand federally proven programs aimed at providing treatment for people with mental illness before they become involved in confrontations with law enforcement, a strategy long advocated by mental health experts, including the Treatment Advocacy Center. The bill also increases training for law enforcement on how to interact with people in a psychiatric crisis and expands data collection on the criminalization of mental illness.
The measure is the most comprehensive proposal to date to deal with the decades’ old problem of warehousing people with mental illness in jails and prisons.
“For too many people who aren’t able to access lifesaving mental health treatment, interaction with the criminal justice system has led to even greater injustice,” said John Snook, executive director of the Treatment Advocacy Center.
“Law enforcement is increasingly on the frontlines of mental health, a position that wastes resources and too often leads to tragic outcomes,” the executive continued. He said as much as twenty percent of the incarcerated population and fifty percent of the people shot and killed by law enforcement each year suffer from a mental illness.
Among many important provisions, the Mental Health and Safe Communities Act would:
- Make assisted outpatient treatment (AOT) eligible for federal funding. AOT provides court-ordered treatment in the community for at-risk people with severe mental illness and has been shown to significantly reduce crime and violence among its target population.
- Fund mental health courts, programs proven to divert qualifying criminal defendants with mental illness from jail into community-based mental health treatment. Nationwide, less than 40% of the U.S. population lives in jurisdictions with mental health courts.
- Promote crisis intervention team training (CIT) for law enforcement. These teams consist of officers who are trained to respond to calls involving mental illness and are consistently found to reduce the arrest and incarceration of individuals with severe mental illness. Nationwide, only 49% of the U.S. population lives in jurisdictions where police departments are using CIT.
- Require reporting on the criminalization of severe mental illness, including reporting on homicides when individuals with mental illness are involved and the cost of treating severe mental illness in the criminal justice system.
The Treatment Advocacy Center supports the efforts of Senator Cornyn to reduce mass incarceration of people with serious mental illness and commends him for providing needed federal leadership in this area.
The Treatment Advocacy Center is a national nonprofit organization dedicated to eliminating barriers to the timely and effective treatment of severe mental illness. The nonprofit promotes laws, policies and practices for the delivery of psychiatric care and supports the development of innovative treatments for and research into the causes of severe and persistent psychiatric illnesses, such as schizophrenia and bipolar disorder.
(This article is a repost from a press release by the Treatment Advocacy Center)
I woke up one day with a diagnosis of schizophrenia. I could not fathom that just like being an addict in Narcotics Anonymous, I also had to learn to believe and accept my disease as a paranoid schizophrenic. “We admitted we were powerless over our addiction, that our lives had become unmanageable”. Please believe it. I know from all of my years of drinking and drugging, self-medicating, I have a lot worse problems than just being a drug addict.
I had to accept my disease and believe that I was really sick. With Narcotics Anonymous meetings and treating my sickness with medication and doctors it has been a long 2 years and 10 months of clean time. Being in and out of hospital situations, my friends, my family, and myself doctors, social workers and other addicts helped to keep me going. Drugs make my disease so much worse. I would never make it not accepting I have schizophrenia. I just wanted to write that down and share it with someone who is sick like me.
In an op-ed for the Washington Post (4/13, 553K), former Sen. Pete Domenici, a senior fellow at the Bipartisan Policy Center, and former Sen. Gordon Smith, president and chief executive of the National Association of Broadcasters, call on the Obama Administration to “issue its final regulations to implement the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act for mental health parity in health insurance.” They note that when Congress passed the Act in 2008, then-Sen. Obama voted for it, and “all indications are that he remains supportive” as president. However, “regulatory action has stalled since 2010. The final rule that would provide clarity to the millions who have a mental illness or substance-use disorder, and to their employers, has not been issued.”
Outstanding event with profound speakers and enthusiastic attendees. Many heroes involved in driving brain research and treatment, especially those who are “consumers”. We thank The Honorable Patrick Kennedy for his passionate, courageous and tenacious work to eliminate discrimination and champion research.