Actavis Receives FDA Approval of SAPHRIS® for Pediatric Patients (age 10-17) for Acute Treatment of Manic or Mixed Episodes of Bipolar I Disorder

DUBLIN, March 13, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for SAPHRIS^® (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 – 17). SAPHRIS is the only atypical antipsychotic treatment option with a sublingual (under the tongue) formulation.

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Approximately 1.2 million children and teens in the United States meet the criteria for bipolar I disorder. Patients with bipolar I disorder experience "mood episodes" ranging from manic episodes, depressive episodes, or mixed episodes (a combination of both mania and depression). Often, younger patients with bipolar I disorder experience more frequent mood episodes.

"We were pleased to see that SAPHRIS was effective across a range of doses, in the largest registrational pediatric trial for an atypical antipsychotic in bipolar I disorder," said David Nicholson, Executive Vice President Global R&D at Actavis. "SAPHRIS is the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last five years. As part of our commitment to mental health, we look forward to making this treatment option available to patients as soon as possible."

The FDA approval of SAPHRIS is based on the results of a 3-week monotherapy trial in 403 pediatric patients (ages 10 – 17), of which 302 pediatric patients received SAPHRIS twice daily in doses of either 2.5 mg, 5 mg or 10 mg.

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 in a pediatric clinical trial.

"Bipolar I disorder in children and teens is a significant public health problem in the U.S. The diagnosis and recognition of bipolar I disorder in children and teens continues to rise, and this illness can often be more severe in pediatric patients than adults," said Kiki Chang, MD, Professor of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Division of Child Psychiatry. "The FDA approval of this pediatric indication for SAPHRIS is very important because it provides an additional treatment option for children and teens affected by this complex condition."

In the pediatric clinical trial 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.

SAPHRIS will be available for pediatric patients with bipolar I disorder in 2.5 mg, 5 mg and 10 mg black cherry flavor sublingual tablets in Q2 2015.

About SAPHRIS^®
SAPHRIS^® (asenapine) is a second-generation atypical antipsychotic that was initially approved in 2009 and is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy or as adjunctive therapy with either lithium or valproate, and for the acute and maintenance treatment of schizophrenia in adults. It is now also indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 – 17) as monotherapy. More than one million prescriptions for SAPHRIS have been dispensed since its initial approval. As of December 2014, asenapine is available in 62 countries.

About Bipolar I Disorder
Bipolar disorder, which encompasses bipolar I and bipolar II disorders, affects approximately 6.2 million people in the United States. Bipolar I disorder is also known as manic-depressive illness. People with bipolar I disorder experience "mood episodes" ranging from manic episodes (i.e., overexcited, extreme irritability, racing thoughts, difficulties with sleep), depressive episodes (i.e., extreme sadness, fatigue, hopelessness), or mixed episodes (a combination of both mania and depression).

IMPORTANT RISK INFORMATION

Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs, including SAPHRIS, are at an increased risk for death. SAPHRIS is not approved for treating people with dementia-related psychosis. An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis.

Severe liver impairment: Do not take SAPHRIS if you have certain liver problems.

Serious allergic reaction: Do not take SAPHRIS (asenapine) if you are allergic to any of its ingredients. Get emergency medical help if you think you are having an allergic reaction. Symptoms may include difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness.

Neuroleptic malignant syndrome (NMS): Stop taking SAPHRIS and 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.

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. TD may not go away, even if you stop taking SAPHRIS. TD may also start after you stop taking SAPHRIS.

SAPHRIS can cause 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 (such as being overweight or a 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 of high blood sugar or diabetes, 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 your treatment with SAPHRIS.
• Weight gain: Your healthcare provider should check your weight regularly.

Also tell your healthcare provider if:

• You have or had low white blood cell counts, because low white blood cell counts and related conditions have been reported with SAPHRIS and similar medicines
• You have any reactions under your tongue (where you place SAPHRIS), such as sores, blisters, peeling/sloughing or inflammation, because these reactions have been reported with SAPHRIS. SAPHRIS may also cause numbness or tingling of the mouth or throat 
• You have certain heart conditions such as irregular heartbeats, or take certain medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances
• You have a seizure disorder, have had seizures, or have conditions that increase your risk for seizures
• You are taking or plan to take prescription or over-the-counter medicines, because there is a risk for drug interactions with SAPHRIS
• You have thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your healthcare provider or go to an emergency room right away
• You have or have had swallowing problems, because SAPHRIS and medicines like it have been associated with swallowing problems and choking
• You experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because SAPHRIS and medicines like it may raise the levels of prolactin. The levels may continue to be high when SAPHRIS is used over time
• You are pregnant or planning to get pregnant while taking SAPHRIS

Other important information to remember:

• Get up slowly after sitting or lying down to avoid getting dizzy, especially at the start of treatment, or when your dose is increased. Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting position has been reported with SAPHRIS
• Do NOT drive or use dangerous machines until you know how SAPHRIS affects you, because SAPHRIS and medicines like it can affect your judgment, thinking, and motor skills
• Be careful when exercising or when doing things likely to cause dehydration or make you warm, because SAPHRIS may make you more sensitive to heat. You may have trouble cooling off
• The most common side effects that occurred with SAPHRIS were:
  • In adults: sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness
  • In children (ages 10-17): sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain

This is not a complete summary of safety information. Please discuss the full Prescribing Information, including Boxed Warning, for SAPHRIS with your doctor.  

About Actavis plc
Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory, and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis' website at www.Actavis.com.

Actavis Cautionary Statement Regarding Forward-Looking Statements

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Annual Report on Form 10-K for the year ended December 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

SOURCE Actavis plc

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