SAPHRIS® (asenapine) 2.5 mg Sublingual Tablets for the Acute Treatment of Manic or Mixed Episodes of Bipolar I Disorder in Pediatric Patients (ages 10-17) Now Available in Pharmacies throughout the U.S.

Jul 17, 2015, 08:00 ET from Allergan plc

DUBLIN, July 17, 2015 /PRNewswire/ -- Allergan plc today announced that SAPHRIS® (asenapine) 2.5 mg sublingual (placed under the tongue) black-cherry flavored tablets are available in pharmacies throughout the U.S. In March 2015, the U.S. Food and Drug Administration (FDA) approved SAPHRIS for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 – 17).

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"The approval of the pediatric indication and the availability of SAPHRIS 2.5 mg tablets at pharmacies throughout the U.S. means that children, teens and their physicians will have a new treatment option available for this complex disorder," said David Nicholson, Executive Vice President Global R&D at Allergan.

Approximately half a million children and teens in the U.S. have experienced symptoms of bipolar I disorder at some time in their lives. Patients with bipolar I disorder experience "mood episodes", which include manic episodes or mixed episodes (consisting of symptoms of both mania and depression). Often, younger patients with bipolar I disorder experience more frequent mood episodes than adults.

"Children with bipolar I disorder can present with varying symptoms and needs, which requires that physicians address the critical need for individualized treatment," said Adelaide Robb, MD, Chief of the Division of Psychology and Behavioral Health, Children's National Medical Center. "SAPHRIS provides an important option for pediatric patients living with this debilitating and serious psychiatric mood disorder."

The FDA approval of SAPHRIS was based on the results of a 3-week monotherapy trial in 403 pediatric patients (ages 10 – 17), the largest registrational pediatric bipolar I mania trial for an atypical antipsychotic to date.i Of pediatric patients enrolled in the trial, 302 received SAPHRIS in doses of either 2.5 mg twice daily, 5 mg twice daily or 10 mg twice daily. SAPHRIS was shown to demonstrate improvement in Young Mania Rating Scale (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) Severity of Illness overall score versus placebo at endpoint at each dose. The most common side effects that occurred with SAPHRIS were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain.

Allergan is committed to helping patients access our medicines. A co-pay card is available on www.SAPHRIS.com.

About SAPHRIS®  
SAPHRIS® (asenapine) is an atypical antipsychotic that was initially approved by the FDA in 2009 for use in adults.  SAPHRIS is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy in adults and pediatric patients (ages 10 – 17), or as adjunctive therapy with either lithium or valproate in adults. SAPHRIS is also indicated for the acute and maintenance treatment of schizophrenia in adults. More than one million prescriptions for SAPHRIS have been dispensed since its initial approval in 2009.

IMPORTANT RISK INFORMATION   
What is the most important information I should know about SAPHRIS?

Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk for death. SAPHRIS is not approved for treating people with dementia-related psychosis.

SAPHRIS may cause serious side effects, including:  

  • Stroke (which can be fatal) in elderly people with dementia
  • Neuroleptic malignant syndrome (NMS): Call your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; or sweating. These can be symptoms of a rare but potentially fatal side effect called NMS. SAPHRIS should be stopped if you have NMS
  • Tardive dyskinesia (TD): Tell your healthcare provider if you cannot control the movements of your face, tongue, or other body parts. These could be signs of a serious and sometimes permanent side effect called TD. Risk of developing TD and the chance that it will become permanent are thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop even after a person has been taking the medicine for a short time at low doses. TD may not go away, even if you stop taking SAPHRIS. TD may also start after you stop taking SAPHRIS
  • Problems with your metabolism, which may increase your risk for heart disease or stroke, such as:
    • High blood sugar and diabetes: If you have diabetes or risk factors for diabetes (eg, being overweight or family history of diabetes), your blood sugar should be tested before you start SAPHRIS and regularly during treatment. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have symptoms such as feeling very thirsty or very hungry, urinating more than usual, or feeling weak
    • Increased blood cholesterol or triglycerides: Your healthcare provider may decide to check your cholesterol and triglyceride levels during treatment
    • Weight gain: Weight gain has been reported with SAPHRIS. Your healthcare provider should check your weight regularly
  • Decreased blood pressure: You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Ask your healthcare provider about ways to reduce feeling dizzy or lightheaded upon standing, such as sitting on the edge of the bed for several minutes before getting up in the morning or slowly rising after sitting
  • Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including SAPHRIS. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics
  • Increases in prolactin levels: Tell your healthcare provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because SAPHRIS may raise the levels of prolactin. The levels may continue to be high when SAPHRIS is used over time
  • Seizures
  • Impaired judgment, thinking, and motor skills: Do NOT drive or use dangerous machinery until you know how SAPHRIS affects you. SAPHRIS may make you drowsy
  • Increased body temperature: SAPHRIS may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm
  • Suicide: Tell your healthcare provider right away or go to an emergency room if you have thoughts of suicide or of hurting yourself or others. People with schizophrenia and bipolar disorder may have these thoughts
  • Difficulty swallowing: SAPHRIS and medicines like it have been associated with difficulty swallowing

Who should not take SAPHRIS?

Do not take SAPHRIS if you have certain liver problems, or if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness).

What should I tell my healthcare provider before taking SAPHRIS?

Tell your healthcare provider about any medical conditions and if you have or have had:

  • Diabetes or high blood sugar in you or your family
  • High levels of total cholesterol, triglycerides, or LDL-cholesterol; or low levels of HDL-cholesterol
  • Seizures or conditions that increase your risk for seizures
  • Low or high blood pressure
  • Low white blood cell count
  • Certain heart problems such as irregular heartbeats or are at risk for these problems, or if you take medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances

Tell your healthcare provider if you are pregnant, or if you plan to become pregnant. SAPHRIS may cause harm to your unborn baby. A special program (National Pregnancy Registry for Atypical Antipsychotics) collects information on the safety of antipsychotic drugs, including SAPHRIS, during pregnancy. For information, contact the program at 1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Tell your healthcare provider about all medicines that you take or have recently taken, including prescriptions, over-the-counter medicines, and supplements. SAPHRIS may affect the way other medicines work, and other medicines may affect how SAPHRIS works.

What are possible side effects of SAPHRIS?

  • The most common side effects in adults were sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness. The most common side effects in children (ages 10-17) were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain
  • Since FDA approval, patients taking SAPHRIS have reported reactions under the tongue (where you place SAPHRIS), such as sores, oral blisters, peeling/sloughing, or inflammation. Choking has also been reported

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all possible side effects of SAPHRIS.

Please see the full Prescribing Information, including Boxed Warning at www.Saphris.com.

About Allergan

Allergan plc, headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com.

i Based on randomized, double-blind, placebo-controlled, U.S. registrational trials of atypical antipsychotics FDA-approved as monotherapy in pediatric patients with bipolar I disorder, as of March 12, 2015.

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