Edgemont - New Fluoxetine Tablets, 60 mg Now Available

AUSTIN, Texas, Jan. 23, 2012 /PRNewswire/ -- Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced Fluoxetine Tablets 60 mg are now available by prescription nationwide. This is the only fluoxetine product available in a 60 mg, single-dose tablet. The U.S. Food and Drug Administration (FDA) approved Edgemont's New Drug Application (NDA) for its fluoxetine tablets in October 2011.

(Photo: http://photos.prnewswire.com/prnh/20120123/NY39251-a)

(Photo: http://photos.prnewswire.com/prnh/20120123/NY39251-b)

Fluoxetine, originally marketed in the U.S. under the brand name Prozac®, is a widely-used treatment for Major Depressive Disorder, Obsessive Compulsive Disorder in adults and pediatrics, and Bulimia Nervosa and Panic Disorder in adults.

"For the first time, patients can now be prescribed a single tablet to achieve their 60 mg daily dose of fluoxetine," said Douglas Saltel, President and CEO of Edgemont.

The tablets are also scored to allow for a convenient half-tablet 30 mg dosing option (1/2 60mg tablet). Previously, patients requiring a 30 mg or 60 mg dose of fluoxetine needed to take three 10 mg pills or three 20 mg pills to achieve their dose, respectively.

Fluoxetine Tablets 60 mg have also been priced to obtain Tier 1 or Tier 2 coverage on most drug plans.

Fluoxetine Tablets 60 mg are available from suppliers today.

For a full copy of the package insert, go to: http://www.edgemontpharma.com/marketed.html

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluoxetine is approved for use in pediatric patients with MDD and Obsessive Compulsive Disorder (OCD).

CONTRAINDICATIONS

• Do not use fluoxetine with a monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing an MAOI due to risk of drug interaction. At least 5 weeks should be allowed after stopping fluoxetine before treatment with an MAOI.
• Do not use fluoxetine with pimozide due to risk of QTc prolongation.
• Do not use fluoxetine with thioridazine due to QTc interval prolongation. Do not use thioridazine within 5 weeks of discontinuing fluoxetine.
• Do not use this fluoxetine product in patients with known hypersensitivity to fluoxetine due to risk of anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria.

WARNINGS AND PRECAUTIONS

• All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms 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 for the emergence of agitation, irritability, unusual changes in behavior, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.
• The development of a potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with selective norepinephrine or serotonin reuptake inhibitors (SNRIs and SSRIs) alone, including fluoxetine treatment, but particularly with concomitant use of serotonergic drugs (including triptans), with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms. The concomitant use of fluoxetine with serotonin precursors (such as tryptophan), is not recommended. Treatment with fluoxetine and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above reactions occur, and supportive symptomatic treatment should be initiated.
• Systemic reactions with rash, possibly related to vasculitis and including lupus-like syndrome, have developed in patients treated with fluoxetine. Although these reactions are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic reactions. Anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria alone and in combination, have been reported. Pulmonary reactions, including inflammatory processes of varying histopathology and/or fibrosis, have been reported rarely. These reactions have occurred with dyspnea as the only preceding symptom. Upon the appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified, fluoxetine should be discontinued.
• A major depressive episode may be the initial presentation of Bipolar Disorder. Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disorder and monitored for mania/hypomania. It should be noted that fluoxetine monotherapy is not approved for use in treating Bipolar I Disorder.
• The percentage of patients experiencing convulsions in all U.S. fluoxetine clinical trials appears to be similar to that associated with other marketed drugs effective in the treatment of Major Depressive Disorder (MDD). Fluoxetine should be introduced with care in patients with a history of seizures. There have been rare reports of prolonged seizures in patients on fluoxetine receiving electroconvulsive treatment.
• Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with fluoxetine. Rarely have patients discontinued treatment with fluoxetine because of anorexia or weight loss. Weight change should be monitored during therapy.
• SNRIs and SSRIs, including fluoxetine, may increase the risk of bleeding reactions. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk.
• Hyponatremia has been reported during treatment with SNRIs and SSRIs, including fluoxetine. Elderly patients and patients taking diuretics or who are otherwise volume-depleted may be at greater risk. Discontinuation of fluoxetine should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.
• In U.S. placebo-controlled clinical trials, among the most common adverse reactions associated with discontinuation (incidence at least twice that for placebo and at least 1% for fluoxetine in trials collecting only a primary reaction associated with discontinuation) were anxiety (2% in Obsessive-Compulsive Disorder [OCD]), insomnia (1% in combined indications and 2% in Bulimia), and nervousness (1% in MDD).
• In patients with diabetes, hypoglycemia has occurred during therapy with fluoxetine, and hyperglycemia has developed following discontinuation of the drug. As is true with many other types of medication when taken concurrently by patients with diabetes, insulin and/or oral hypoglycemic, dosage may need to be adjusted when therapy with fluoxetine is instituted or discontinued.
• Mydriasis has been reported in association with fluoxetine; therefore, caution should be used when prescribing fluoxetine in patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma.
• Fluoxetine has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.
• Because of the long elimination half-lives of the parent drug and its major active metabolite, changes in dose will not be fully reflected in plasma for several weeks, affecting both strategies for titration to final dose and withdrawal from treatment.
• During marketing of fluoxetine, SNRIs, and SSRIs, there have been spontaneous reports of adverse reactions occurring, some of which have been serious, upon discontinuation of these drugs, particularly when abrupt. Patients should be monitored for these symptoms when discontinuing treatment with fluoxetine. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.

ADVERSE REACTIONS

• Most common adverse reactions associated with the use of fluoxetine (incidence of 5% and at least twice that for placebo, within at least one of the indications) for the treatment of MDD, OCD and Bulimia in U.S. controlled clinical trials and Panic Disorder in U.S. plus non-U.S. controlled trials: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn.

About Edgemont Pharmaceuticals

Formed in 2006, Edgemont Pharmaceuticals is a privately held company with expertise in the field of neuroscience. The Company is committed to the development of novel drug formulations and new therapies that provide important clinical benefits and improve patient care.

Prozac® is a registered trademark of Eli Lilly and Company.

SOURCE Edgemont Pharmaceuticals, LLC

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