U.S. FDA Approves New 60 mg Dosage Strength of Fluoxetine

AUSTIN, Texas, Oct. 11, 2011 /PRNewswire/ -- Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

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

Edgemont's Fluoxetine 60 mg tablet is the only fluoxetine product to offer a 60 mg dose in a single pill. The tablets also have a functional score to allow for a convenient half-tablet 30 mg dosing option. Until now, patients requiring a 30 mg or 60 mg dose of fluoxetine have needed to take three 10 mg pills or three 20 mg pills to achieve their target dose.

Patient therapy adherence remains a major clinical issue; approximately 40% of patients undergoing antidepressant therapy become non-compliant within three months of therapy initiation(2). Numerous published studies have also demonstrated a statistically significant improvement in patient therapy adherence when the number of pills per dose is reduced(1).

"By reducing the number of pills per dose from three pills to one, we are hopeful that our Fluoxetine 60 mg Tablets may help patients be more therapy compliant. This is an especially important goal for the higher milligram dose patients that may be having trouble controlling their symptoms of depression," said Douglas Saltel, President and CEO of Edgemont.

Edgemont's goal is to ensure broad patient access by aggressively pricing its Fluoxetine 60 mg Tablets in the range of generics. Edgemont expects to begin shipping product in approximately four weeks.

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 an 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.

Warnings & 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, and the other symptoms described above, 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 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.  
• 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 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.
• 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. It should be noted that fluoxetine monotherapy is not approved for use in treating Bipolar I Disorder.  
• 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.

References:
1. Bangalore S et al. American Journal of Medicine (2007) 120,713-719
2. Burton W, et al AM J Managed Care 2007 Feb;13(2): 105-12

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

SOURCE Edgemont Pharmaceuticals, LLC