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FDA Approves sNDA for Invega Sustenna (paliperidone palmitate) for Schizoaffective Disorder

TITUSVILLE, N.J., Nov. 13, 2014 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. The symptoms of schizoaffective disorder are complex and, without treatment, disabling. The FDA approved these sNDAs under priority review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

Invega Sustenna is the first and only FDA-approved once-monthly medication to treat schizoaffective disorder as monotherapy.

"Clinicians often find themselves taking a complicated approach using multiple medications to address schizoaffective disorder symptoms because widely accepted guidelines for the treatment of the condition are not available," said David P. Walling, PhD, study lead investigator and Chief Executive and Clinical Officer, Collaborative NeuroScience Network, Inc., Los Angeles. "The approval of an effective once-monthly medication that can be used as monotherapy or adjunctive therapy to manage the symptoms associated with schizoaffective disorder has the potential to change that approach."

The approval is based on data from a 15-month period of a long-term maintenance study measuring ability to delay relapse in schizoaffective disorder. The study found that treatment with Invega Sustenna resulted in a statistically significant delay in relapse due to mood (depression and mania) and psychotic symptoms of schizoaffective disorder compared to placebo. Results of the study were presented in May at the 167th Annual Meeting of the American Psychiatric Association. "Schizoaffective disorder is a difficult-to-treat disease. Approval of Invega Sustenna to manage the mood as well as the psychosis that define the condition has the potential to change the lives of the 750,000 adult Americans who suffer from it," said Dong-Jing Fu, MD, PhD, Director of Clinical Development at Janssen Scientific Affairs, LLC. "Janssen is proud to expand treatment options for those living with schizoaffective disorder and to provide new possibilities for the family members and friends who care for them."

Few large, controlled studies have systematically studied the clinical characteristics of schizoaffective disorder and long-term treatment options. This study, which included a 6-month open-label treatment period and a 15-month double-blind period, was the first registration trial to study maintenance treatment of a long-acting injectable in this complex disease. In addition to the approval of Invega Sustenna as monotherapy for schizoaffective disorder, it is approved as adjunctive therapy to mood stabilizers or antidepressants.

The most common Invega Sustenna adverse reactions, defined by at least a 5% incidence and twice that of placebo, are injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder. No occurrences of these adverse events reached this threshold in this study of patients with schizoaffective disorder.

About Schizoaffective Disorder

Schizoaffective disorder is a mental illness with an overlap of psychotic and mood symptoms. Psychotic symptoms include delusions or hallucinations, and mood symptoms include depression and mania. The exact cause of schizoaffective disorder is unknown. The disorder is diagnosed via a mental health assessment of symptoms over an extended period of time conducted by a licensed mental health professional. The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5 or current version). Schizoaffective disorder is a complex condition that is generally treated with a combination of medications. In 2009, Invega, another product manufactured by Janssen, became the first atypical antipsychotic approved to treat schizoaffective disorder. Other than Invega (paliperidone) and Invega Sustenna (paliperidone palmitate), there are no antipsychotic medications indicated to treat this disorder in the U.S. or most other countries, and no widely accepted guidelines for the treatment of the disease are available.

About Janssen Pharmaceuticals, Inc.

As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Pharmaceuticals, Inc., is dedicated to addressing and resolving the major unmet medical needs of our time. Driven by our commitment to patients, healthcare professionals, and caregivers, we strive to develop sustainable and integrated healthcare solutions by working in partnership with all stakeholders on the basis of trust and transparency. Our daily work is guided by meeting goals of excellence in quality, innovation, safety, and efficacy in order to advance patient care. Our company provides medicines for an array of illnesses and disorders in several therapeutic areas. For more information on Janssen Pharmaceuticals, Inc., visit us at www.JanssenPharmaceuticalsInc.com or follow us on Twitter at www.Twitter.com/JanssenUS and on YouTube at www.YouTube.com/JanssenUS.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding approval of a new indication. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., Janssen Scientific Affairs, LLC, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to laws and regulations, including domestic and foreign health care reforms; and general industry conditions, including trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments).

SOURCE Janssen Pharmaceuticals, Inc.

Posted: November 2014

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