Actavis Receives FDA Approval for VIIBRYD® (vilazodone HCl) 20mg Once Daily as a Therapeutic Dose

DUBLIN, March 16, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced the U.S. Food and Drug Administration (FDA) has approved a lower therapeutic dose of VIIBRYD^® (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose. This supplemental new drug application (sNDA) approval for VIIBRYD expands dosing options available to health care providers when using VIIBRYD to treat their adult patients with MDD. The VIIBRYD 20mg therapeutic dose is now available in pharmacies.

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VIIBRYD was approved in January 2011 as the first and only selective serotonin reuptake inhibitor (SSRI) and 5HT1a receptor partial agonist for the treatment of MDD in adults at a dose of 40 mg/day. The approval of the 20 mg dose fulfills a post-marketing commitment with the FDA to identify the minimum effective dose of vilazodone.

Approval of the 20 mg dose was supported by a 10-week, multicenter, double-blind, placebo-controlled and active-comparator, parallel-group, fixed-dose trial of 1133 adult patients with MDD. The primary efficacy outcome was the mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week 10. Significantly greater reduction in mean MADRS total scores from baseline to week 10 was found in both vilazodone treatment groups (Least square mean difference (LSMD): vilazodone 20, 40 mg/day: -2.6, -2.8 respectively) compared with placebo. A secondary outcome was the change from baseline to week 10 on the Clinical Global Impressions-Severity scale (CGI-S), which is a measure of illness severity that is commonly used in MDD clinical trials. Both vilazodone dose groups significantly reduced illness severity compared with placebo as measured by the change from baseline in CGI-S score. For both the MADRS total score and CGI-S score, significant differences in favor of the vilazodone groups were observed as early as week 2 and were maintained through week 10. Whether the statistically significant differences observed at time points earlier than 10 weeks in MADRS total score and CGI-S score represent clinically relevant treatment effects in this study are unknown. Adverse events that occurred in at least 5% of patients in either vilazodone dose group and at twice the rate of placebo were diarrhea, nausea, insomnia, and vomiting. These results support the efficacy, safety, and tolerability of VIIBRYD 20 mg once daily as a therapeutic dose in the treatment of MDD in adults.

VIIBRYD has been shown to be effective in the treatment of MDD in adults across 4 clinical studies. VIIBRYD should be taken with food and initiated at a dose of 10 mg once daily for 7 days, followed by 20 mg once daily. Based on efficacy and tolerability, the dose may be increased to 40 mg daily after a minimum of 7 days between dosage increases.

About Vilazodone
Vilazodone, also known by its brand name VIIBRYD, is a selective serotonin reuptake inhibitor (SSRI) and 5-HT1A receptor partial agonist approved by the FDA for the treatment of adults with Major Depressive Disorder (MDD). While the mechanism of the antidepressant effect of vilazodone is not fully understood, it is thought to be related to enhancement of serotonergic activity through selective inhibition of serotonin reuptake. The role of 5HT1A partial agonist activity on serotonergic transmission and antidepressant effect is unknown.

Visit www.VIIBRYD.com for more information.

IMPORTANT RISK INFORMATION

What is the most important information I should know about VIIBRYD?

VIIBRYD and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the symptoms described below, or call 911 if there is an emergency.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts or actions in some people 24 years of age and younger. Watch closely for worsening depression and for suicidal thoughts and behaviors. Call your healthcare provider right away if you notice any new or sudden changes in mood, behavior, thoughts or feelings. Pay particular attention when VIIBRYD is started or when the dose is changed.

VIIBRYD is not approved for use in patients under 18.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• Attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent; thoughts about suicide or dying; new or worse depression, anxiety, or panic attacks; feeling agitated, restless, angry or irritable; trouble sleeping; an increase in activity or talking more than normal (mania); or other unusual changes in behavior or mood

Serotonin Syndrome: Agitation, hallucinations, coma or other changes in mental status; coordination problems or muscle twitching; fast heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting or diarrhea; muscle stiffness or tightness.

Increased chance of bleeding: VIIBRYD and other antidepressant medicines may increase your chance of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin^®, Jantoven^®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.

Manic episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.

Discontinuation symptoms: Do not suddenly stop VIIBRYD without first talking to your healthcare provider. Stopping VIIBRYD suddenly may cause serious symptoms including: flu-like symptoms (eg, headache, sweating, nausea); anxiety, high or low mood, irritability, feeling restless or sleepy; dizziness, electric shock-like sensations, tremor, and confusion.

Seizures or convulsions.

Glaucoma (angle-closure glaucoma): Many antidepressants, including VIIBRYD, may cause an eye problem called angle-closure glaucoma. Call your healthcare provider if you have changes in your vision or eye pain.

Low salt (sodium) levels in the blood: Elderly people may be at greater risk for this.  Symptoms may include headache; weakness or feeling unsteady; confusion, problems concentrating or thinking or memory problems.

Who should not take VIIBRYD?

• Do not take any drugs known as monoamine oxidase inhibitors (MAOIs), including linezolid (an antibiotic), with VIIBRYD or within 14 days of stopping VIIBRYD
• Do not start VIIBRYD if you started or stopped taking an MAOI in the last 14 days

People who take VIIBRYD close in time to taking an MAOI may have serious or even life-threatening side effects.

What should I tell my healthcare provider before taking VIIBRYD?

• Tell your healthcare provider about any medical conditions or if you:
  • Have liver or kidney problems
  • Have or had mania, bipolar disorder (manic depression), seizures or convulsions
  • Have or had bleeding problems. VIIBRYD may increase your chance of bleeding or bruising
  • Have low salt (sodium) levels in your blood or are taking diuretics (water pills)
  • Drink alcohol
  • Are pregnant, breastfeeding or are planning to become pregnant or to breastfeed
• Tell your healthcare provider about all prescription, over-the-counter medications, vitamins, and herbal supplements you are taking or plan to take, especially:
  • Triptans used to treat migraine headaches; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics; tramadol, mephenytoin (Mesantoin) or over-the-counter supplements such as tryptophan or St. John's Wort; this is necessary to avoid a potentially life-threatening condition
  • Aspirin, NSAID pain relievers, or blood thinners (eg, warfarin, Coumadin, or Jantoven) because they may increase the risk of bleeding
  • Diuretics (water pills)

What should I avoid when taking VIIBRYD?

• Until you know how VIIBRYD affects you, you should not drive, operate heavy machinery, or engage in other dangerous activities. Avoid drinking alcohol while taking VIIBRYD.

What are the most common side effects of VIIBRYD? =

• The most common side effects in people taking VIIBRYD include diarrhea, nausea or vomiting, and trouble sleeping.
• Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VIIBRYD. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

About Major Depressive Disorder (MDD)
MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7% of the adult U.S. population. MDD, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms occur nearly every day for at least two weeks and interfere with a person's ability to function. Depression costs the U.S. an estimated $83 billion each year. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability by the year 2020.

About Actavis

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.

Forward-Looking Statement

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' 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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