Forest Laboratories, Inc. (NYSE:FRX) today announced it will be presenting data from its Major Depressive Disorder (MDD) portfolio, levomilnacipran and vilazodone, at the American Psychiatric Association (APA) 167th annual meeting (May 3-7, 2014 in New York, N.Y.).

The levomilnacipran results will be announced in four poster presentations:

May 5th, 2:30-4:00 PM EDT:

  • Clinical Relevance of Levomilnacipran ER Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories (poster #NR6-091), authored by Andrew Cutler, MD
  • The Efficacy of Levomilnacipran ER Across Symptoms of Major Depressive Disorder: Pooled Analyses of MADRS items and Residual Symptoms (poster #NR6-104), authored by William M. Greenberg, MD
  • Treating Major Depressive Disorder With Levomilnacipran ER: Efficacy and Tolerability Across the Dose Range (poster #NR6-087), authored by Gregory M. Asnis, MD
  • The Efficacy of Levomilnacipran ER in the Treatment of Patients With Depression-Associated Fatigue Symptoms (poster #NR6-100), authored by Marlene Freeman, MD

The vilazodone results will be announced in six poster presentations:

May 5th, 2:30 - 4:00 PM EDT:

  • Efficacy and Safety of Vilazodone 20 mg and 40 mg in Major Depressive Disorder: A Randomized, Double-Blind, Placebo- and Active-Controlled Trial (poster #NR6-103), authored by Carl Gommoll, MD
  • An Evaluation of Sexual Dysfunction During Treatment of Major Depressive Disorder with Vilazodone 20 mg and 40 mg, Citalopram, or Placebo: Results From a Phase III Clinical Trial (poster #NR6-113), authored by Maju Mathews, MD
  • The Efficacy of Vilazodone in Achieving Remission in Patients With Major Depressive Disorder: Post Hoc Analyses of a Phase IV Trial (poster #NR6-090), authored by Leslie Citrome, MD
  • Early Improvement with Vilazodone in Adults with Major Depressive Disorder: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled Trial (poster #NR6-120), authored by Ashwin Patkar, MD
  • The Efficacy of Vilazodone in Improving Anxiety Symptoms in Patients with Major Depressive Disorder: Post Hoc Analyses of a Phase IV Trial (poster # NR6-124), authored by Angelo Sambunaris, MD

May 6, 2:30 - 4:00 PM EDT:

  • Effects of Vilazodone on Depression Symptoms: Category Shift Analysis of MADRS Items From a Randomized, Double-Blind, Placebo-Controlled Trial (poster # NR8-057), authored by Michael E. Thase, MD

About levomilnacipran ER capsules

FETZIMA (levomilnacipran) is a serotonin norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults. The recommended therapeutic dose range for FETZIMA is 40 mg to 120 mg once daily with or without food. The exact mechanism of the antidepressant action (MOA) is unknown, but 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 SNRI. FETZIMA potently inhibits serotonin (5-HT) and norepinephrine reuptake (IC50=16-19 nM and 11 nM, respectively). Greater reuptake inhibition of norepinephrine over serotonin was shown in vitro.

Levomilnacipran was licensed to Forest Laboratories Inc. by Pierre Fabre, in the U.S. and Canada. Pierre-Fabre is also the active pharmaceutical ingredient (API) supplier.

Visit FETZIMA.com for more information on this once-daily option for the treatment of MDD in adults.

About vilazodone HCl

VIIBRYD (vilazodone) is the first and only selective serotonin reuptake inhibitor (SSRI) and 5-HT1A receptor partial agonist for the treatment of adults with MDD. While the mechanism of action is not fully understood, it is thought to be related to enhancement of serotonergic activity in the central nervous system (CNS) through selective inhibition of serotonin reuptake. The role of 5-HT1A partial agonist activity on serotonergic transmission and antidepressant effect is unknown. VIIBRYD offers consistent efficacy and has an established safety profile with reported rates of sexual dysfunction of less than 5% and no effect on weight gain in pivotal trials. The recommended dose is 40 mg. VIIBRYD was approved in 2011 and is available in pharmacies across the U.S.

Visit VIIBRYD.com for more information on this once-daily option for the treatment of MDD in adults.

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.

VIIBRYD and FETZIMA are not approved for use in pediatric patients.

VIIBRYD Contraindications

  • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with VIIBRYD or within 14 days of stopping treatment with VIIBRYD. Do not use VIIBRYD within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start VIIBRYD in a patient who is being treated with linezolid or intravenous methylene blue.

VIIBRYD Warnings and Precautions

  • All patients 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 changing 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 VIIBRYD should be written for the smallest quantity of tablets 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, including VIIBRYD, 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 were noted in 0.1% of VIIBRYD-treated patients in premarketing clinical trials. Serotonin syndrome symptoms 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 occur, discontinue VIIBRYD and initiate supportive treatment. If concomitant use of VIIBRYD 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.
  • Like other antidepressants, VIIBRYD should be prescribed with caution in patients with a seizure disorder.
  • The use of drugs that interfere with serotonin reuptake, including VIIBRYD, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of VIIBRYD and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation or bleeding.
  • Symptoms of mania/hypomania were noted in 0.1% of patients treated with VIIBRYD in clinical studies. As with all antidepressants, VIIBRYD should be used cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania. Prior to initiating treatment with VIIBRYD, patients should be adequately screened to determine if they are at risk for bipolar disorder. VIIBRYD is not approved for use in treating bipolar depression.
  • Discontinuation symptoms, some serious, have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients when discontinuing VIIBRYD. 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 VIIBRYD. Although no cases of hyponatremia resulting from VIIBRYD treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. Discontinuation of VIIBRYD in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

VIIBRYD Adverse Reactions

  • The most commonly observed adverse reactions in MDD patients treated with VIIBRYD in placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were: diarrhea (28% vs 9%), nausea (23% vs 5%), insomnia (6% vs 2%), and vomiting (5% vs 1%).

FETZIMA Contraindications

  • 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. In clinical studies, FETZIMA was associated with an increased risk of mydriasis.

FETZIMA 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, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue FETZIMA immediately 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. Use with caution in patients with pre-existing hypertension, cardiovascular, or cerebrovascular conditions that might be compromised by increases in blood pressure. Concomitant use of FETZIMA with drugs that increase blood pressure and heart rate has not been evaluated and such combinations should be used with caution. 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, NSAIDs, warfarin, 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 or those at risk of acute narrow-angle (angle-closure) glaucoma should be monitored. DO NOT use FETZIMA in patients with uncontrolled narrow-angle glaucoma.
  • FETZIMA can affect urethral resistance. In clinical studies, urinary hesitation occurred in 4%, 5% and 6% of FETZIMA-treated patients receiving doses of 40, 80, and 120 mg, respectively, compared to no patients in the placebo group. 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.

FETZIMA Adverse Reactions

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 Forest Laboratories, Inc.

Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in five therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, and anti-infective. Forest’s strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions allows Forest to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. In January 2014, Forest acquired Aptalis Pharmaceuticals for $2.9 billion in cash in order to gain access to its GI and Cystic Fibrosis products, including treatments for Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures, and Pancreatic Insufficiency. In February 2014, Forest and Actavis plc announced an agreement where Forest would be acquired for about $25 billion in cash and stock. The acquisition of Forest by Actavis is contingent upon regulatory and shareholder approvals.

Forest is headquartered in New York, NY.

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 potential that the presentations identified above are not given at all or at the times or locations specified, in addition to the risk factors listed from time to time in each of Forest's and Ironwood's Annual Reports on Form 10‐K, Quarterly Reports on Form 10‐Q, and other SEC filings. Neither Forest nor Ironwood undertakes any obligation to update these forward-looking statements to reflect events or circumstances occurring after this press release. These forward looking statements speak only as of the date of this press release. All forward‐looking statements are qualified in their entirety by this cautionary statement.