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7/26/2013 6:37:56 AM
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Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of FETZIMA™ for the Treatment of Major Depressive Disorder in Adults
NEW YORK & CASTRES, France--(BUSINESS WIRE)-- Forest Laboratories, Inc. (FRX) and Pierre Fabre Laboratories announced today that FETZIMA™ (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), discovered by Pierre Fabre Laboratories and co-developed by Forest Laboratories, Inc. was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder (MDD) in adults.
Major Depressive Disorder, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. MDD affects almost 16 million adults in the United States every year, with a range of severity from mild to severe.
In the placebo-controlled, pivotal Phase III studies of adult patients with MDD, statistically significant and clinically meaningful improvement in depressive symptoms (primary endpoint) was demonstrated across three FETZIMA dosage strengths of 40, 80, and 120 mg once daily compared with placebo as measured by the Montgomery Åsberg Depression Rating Scale (MADRS) total score (primary endpoint). FETZIMA also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score (secondary endpoint).
“Because people respond differently to different medications, Forest Laboratories is dedicated to bringing a range of treatment possibilities to adults living with MDD, as part of our growing mental health portfolio,” said Howard Solomon, Chairman, Chief Executive Officer and President of Forest Laboratories. “The approval of FETZIMA fulfills that commitment to the millions of people living with MDD.”
"We are proud that another product stemming from Pierre Fabre’s research has received approval in the United States. This marketing authorisation represents a key milestone for our laboratory, and it confirms our choice to make neuropsychiatry a strategic axis of our R&D efforts, next to oncology and dermatology ", said Frédéric Duchesne, President Pharmaceutical Division, Pierre Fabre Laboratories.
The most common adverse reactions (incidence =5% and at least twice the rate of placebo) in the placebo-controlled trials were nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations. Rates of adverse events were generally consistent across doses (40-120 mg); the only dose-related adverse events (greater than 2% overall incidence) were urinary hesitation and erectile dysfunction.
“As many people with MDD struggle to find a treatment that works for them, FETZIMA provides patients and physicians with an additional option for treating this serious disease,” said Michael Liebowitz, MD, Professor of Clinical Psychiatry at Columbia University.
Forest Laboratories Inc. expects FETZIMA to be available to wholesalers in the 4th calendar quarter 2013.
The efficacy of FETZIMA was demonstrated in three positive double-blind Phase III studies comprising two fixed-dose studies and one flexible-dose study that compared FETZIMA to placebo in adults with MDD. A total of more than 1,600 adult patients received a once-daily dose of either FETZIMA (40, 80, 120mg) or placebo in the three studies. In each study, the primary endpoint was change from baseline to endpoint in the Montgomery Åsberg Depression Rating Scale (MADRS) total score and the secondary endpoint was change from baseline to endpoint in the Sheehan Disability Scale (SDS) total score. In all three studies, statistically significant improvement was seen for the FETZIMA group compared with placebo on both the primary and secondary endpoints using both the mixed-effects model for repeated measures (MMRM) and last-observation-carried-forward (LOCF) analyses.
Primary Endpoint MADRS (Reduction in depressive symptoms)
In all three studies, FETZIMA demonstrated superiority over placebo in the improvement of depressive symptoms as measured by the change from baseline to Week 8 in the MADRS total score. MADRS is a widely used, clinician-rated scale to assess the severity of 10 depressive symptoms. A total MADRS score of 35 or greater is suggestive of severe depression. The primary efficacy endpoint in the pivotal trials was change from baseline to week 8 in the total MADRS score. A 2-point difference between drug effect and placebo is generally considered to represent a clinically meaningful improvement in depressive symptoms.
For study 1, the mean baseline MADRS total score was 36 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at all three FETZIMA doses (-3.2 at 40 mg/day, -4.0 at 80 mg/day, and -4.9 at 120 mg/day). For study 2, the mean baseline MADRS total score was 31 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at both FETZIMA doses studied (-3.3 at 40 mg/day, -3.1 at 80 mg/day). For study 3, the mean baseline MADRS total score was 35 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant for the FETZIMA dosing range studied (-3.1 at 40-120 mg/day).
Secondary Endpoint SDS (Improvement in functional impairment)
FETZIMA also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score. SDS is a validated scale that measures the extent that emotional symptoms disrupt patient functioning in 3 life domains: work/school, social life, and family life with each item scored from 0 (unimpaired) to 10 (highly impaired).
About Major Depressive Disorder
MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7.3% 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 work, sleep, study, eat, and enjoy once-pleasurable activities. Depression costs the U.S. an estimated $44 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.
FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD). The recommended therapeutic dose range for FETZIMA is 40 mg to 120 mg once daily and can be taken with or without food.
While the exact mechanism is unknown, it is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of reuptake at serotonin and norepinephrine transporters. Non-clinical studies have shown that FETZIMA is a potent and selective serotonin and norepinephrine reuptake inhibitor.
Levomilnacipran was licensed to Forest Laboratories Inc. by Pierre Fabre, in the U.S. and Canada. Pierre-Fabre will also be the active pharmaceutical ingredient (API) supplier.
Visit FETZIMA.com for more information on this once-daily option for the treatment of MDD in adults.
FETZIMA Indication and Usage
FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD).
FETZIMA is not approved for the management of fibromyalgia. Efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.
Important Safety Information
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. FETZIMA is not approved for use in pediatric patients.
FETZIMA is contraindicated in patients with a hypersensitivity to levomilnacipran, milnacipran HCl, or to any excipient in the formulation.
The use of MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA is contraindicated due to an increased risk of serotonin syndrome. The use of FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.
Starting FETZIMA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated due to an increased risk of serotonin syndrome.
Do not use FETZIMA in patients with uncontrolled narrow-angle glaucoma.
Warnings and Precautions
All patients being treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when increasing or decreasing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients daily. Prescriptions for FETZIMA should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue FETZIMA and initiate supportive treatment. If concomitant use of FETZIMA with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
SNRIs, including FETZIMA, have been associated with increases in blood pressure. Blood pressure should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Pre-existing hypertension should be controlled before initiating treatment with FETZIMA. For patients who experience a sustained increase in blood pressure, discontinuation or other appropriate medical intervention should be considered.
SNRIs including FETZIMA have been associated with an increase in heart rate. Heart rate should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Pre-existing tachyarrhythmias and other cardiac disease should be treated before starting therapy with FETZIMA. For patients who experience a sustained increase in heart rate, discontinuation or other appropriate medical intervention should be considered.
SSRIs and SNRIs, including FETZIMA, may increase the risk of bleeding events, some serious. Concomitant use of aspirin, warfarin, NSAIDs and other anticoagulants may add to this risk.
Mydriasis has been reported in association with SNRIs including FETZIMA; therefore, FETZIMA should be used with caution in patients with controlled narrow-angle glaucoma. Patients with raised intraocular pressure should be monitored. DO NOT use FETZIMA in patients with uncontrolled narrow-angle glaucoma.
SNRIs, including FETZIMA, can affect urethral resistance. Caution is advised when using FETZIMA in patients prone to obstructive urinary disorders.
Symptoms of mania/hypomania were reported in 0.2% of FETZIMA-treated patients and 0.2% of placebo-treated patients in clinical studies. As with all antidepressants, FETZIMA should be used cautiously in patients with a history or family history of bipolar disorder, mania or hypomania. Prior to initiating treatment with FETZIMA, patients should be adequately screened to determine if they are at risk for bipolar disorder. FETZIMA is not approved for use in treating bipolar depression.
FETZIMA should be prescribed with caution in patients with a seizure disorder.
Discontinuation symptoms, some serious, have been reported with discontinuation of serotonergic antidepressants such as FETZIMA. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients when discontinuing FETZIMA. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.
Advise patients that if they are treated with diuretics or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking FETZIMA. Although no cases of hyponatremia resulting from FETZIMA treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. FETZIMA should be discontinued in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.
The most commonly observed adverse reactions in MDD patients treated with FETZIMA in placebo-controlled studies (incidence =5% and at least twice the rate of placebo) were: nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations.
About Pierre Fabre
Pierre Fabre Laboratories, the second largest independent pharmaceutical group in France, achieved a turnover of 1.98 billion Euros in 2012, with international sales accounting for 54%. Pierre Fabre has branches in 42 countries and its products are distributed in over 130 countries.
Through the holding company Pierre Fabre Participations, 65% of Pierre Fabre SA is held by the Pierre Fabre Foundation, recognized as a public utility since 1999. In addition, thanks to an employee shareholding program set up in 2005, 90% of the company’s employees collectively have a 7 % shareholding interest. This original governance program ensures the independence and sustainability of the company.
Their activities cover all aspects of healthcare, from prescription drugs and family health products to dermo-cosmetics. Pierre Fabre Laboratories employ some 10,000 people worldwide, 1,400 of whom are dedicated to R&D. Every year, the group allocates 20% of its drug revenues to R&D, focusing on three main areas: oncology, dermatology and neuropsychiatry.
With brands including Avène, Glytone, A-Derma, Ducray, Galénic, Klorane, Naturactive, René Furterer or Pierre Fabre Oral Care, Pierre Fabre Laboratories are France’s market leaders when it comes to skin, hair and oral care products sold in the pharmacy channel. Avène is marketed in over 100 countries, and is the leading dermo-cosmetics brand in Europe, Japan and China. In prescription drugs, Pierre Fabre focuses on four therapeutic areas: oncology, dermatology, neuropsychiatry and women’s health. In oncology, Pierre Fabre achieves about 90% of its turnover outside its home country.
In 2012, Pierre Fabre Laboratories was audited by the French certification group AFNOR at advanced level for its corporate social responsibility (CSR) performance. To learn more, visit www.pierre-fabre.com.
About Forest Laboratories, Inc.
Forest Laboratories' (FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.
Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice President – Investor Relations
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