FDA Approves ARISTADA™ for Treatment of Schizophrenia

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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.

Conference Call

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

SARDAA Founder at IMHRO Music Festival for Brain Health

Linda Stalters, SARDAA Executive Director & founder and her husband, Russ Stalters, SARDAA volunteer, traveled to the Staglin Family Vineyard in Rutherford, CA to support the One Mind Institute (IMHRO) 21st Music Festival for Brain Health fundraiser. Linda stated “I feel so strongly about the importance of  cutting-edge research to better diagnose, treat, prevent, and, ultimately, cure severe brain disorders that my husband and I are willing to personally donate to this important cause. This research is vital and complimentary to the work SARDAA is doing to support those diagnosed and their families and to increase awareness.”

21 IMHRO Music Festival Scientific SymposiumThe day started off with a Scientific Symposium featuring rock-star neuroscientists presenting updates on the state of brain health research and discussing paths for prevention and cures for brain disorders followed by a Q&A session with the experts.

In this short video below Linda was able to catch up with Brandon Staglin to thank him for all the work he has done as Board member of One Mind Institute (IMHRO) and as a member of the SARDAA Consumer Advisory Council.

Mental Health Reform Forum October 7

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.



Hear what schizophrenia sounds like with #HearOurVoices

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:

  1. 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)
  2. Share your experiences or support by using the #HearOurVoices hashtag on Twitter, Facebook, and other social media sites.
  3. 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.

Retinal Changes Provide Clues About The Progression Of Schizophrenia

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.

Schizophrenia and Omega-3s

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.


Ambitious Plan to Reduce Mass Incarceration Focuses on Mental Illness

(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)





      Joanne Verbanic, founder of Schizophrenics Anonymous, an international self-help group for people with Schizophrenia that is modeled after Alcoholics Anonymous, died May 7th in Detroit of complications following abdominal surgery. She was 70 years old.

       Ms. Verbanic, who suffered from paranoid schizophrenia throughout her adult life, put a small ad in a Detroit newspaper in 1984 inviting people burdened with the same illness to meet and talk in a diner in downtown Detroit. Three people came. Today, Schizophrenics Anonymous has peer-support chapters throughout the world and is linked with an umbrella mental health organization called Schizophrenia and Related Disorders Alliance of America, or SARDAA. Schizophrenics Anonymous’ estimated global membership is thousands.

      Stricken with the illness as a young mother, Ms. Verbanic managed to continue working as a financial counselor at Ford Motor Company for more than 20 years following a divorce, despite the constant intervention of internal “voices” that plague so many patients with the disease. Acting alone, she taught herself to ignore the taunting and threatening that comes from internal voices, which are auditory hallucinations and a common symptom of the illness. Her ability to back away from them, almost unheard-of until she pioneered the technique, was a major lesson she passed on to her followers. She never attempted to suggest that she had found a cure for the illness, just a helpful way to manage it.

        Ms. Verbanic was also known as a tireless mother-hen to Schizophrenics Anonymous members, taking local and long-distance telephone calls any hour of the day or night in her Detroit home, sitting in on chapter meetings, organizing help for members in trouble, traveling to make speeches and accept awards. Beyond her interest in peer-group work, she was a tireless crusader against the public stigma that attaches to people with mental illness. “Sometimes I think the stigma is worse than the disease,” she told a reporter from Time Magazine.

       Ms. Verbanic is survived by her son, Dennis, her brother, Robert Gaynor Jr., sister, Jeanette Christiansen, and her granddaughter, Christina Bowers. She was preceded in death by her son, Douglas, her brothers, Tim and Jim, and her sister, Cindy Fraser.

Integrating Substance Use Disorder and Health Care Services in an Era of Health Care Reform

Integrating Substance Use Disorder and Health Care Services in an Era of Health Care Reform  This white paper is the first in a series of white papers from SAMHSA’s Addiction Technology Transfer (ATTC) Network discussing the unique issues involved in integrating substance use disorder services in health care

Help Support SARDAA!

Please take a moment to find out how you can help support SARDAA, not only today but every day – at no extra cost to you!!

When you shop at AmazonSmile, Amazon donates 0.5% of the purchase price to Schizophrenia And Related Disorders Alliance Of America.

IT’S SO SIMPLE: just bookmark this link http://smile.amazon.com/ch/33-1213657, start shopping and support us every time you shop.

Texas and Louisiana Friends:
You can support SARDAA without spending a penny! Register Schizophrenia and Related Disorders on your Kroger Plus Card and they will donate a percentage to SARDAA each time you use your card.

2014 Re-Enrollment Info in English and Spanish (PDF)
Please register online at www.krogercommunityrewards.com
Link to: Schizophrenia and Related Disorders–Kroger Plus Card 90425

Re-Enroll Your Kroger Plus Cards Beginning August 1st.