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Edgemont Pharmaceuticals, LLC. Release: New Higher Dose Bupropion Extended-Release Tablets Now Available  
10/9/2012 10:44:19 AM

AUSTIN, Texas, Oct. 9, 2012 /PRNewswire/ -- Edgemont Pharmaceuticals, LLC, a neuroscience-focused company, today announced that Forfivo XL (bupropion hydrochloride extended-release tablets) is now available nationwide for the treatment of major depressive disorder (MDD). Forfivo XL is the only extended-release bupropion HCl product to offer a once-daily, 450mg dose in a single tablet.

(Photo - http://photos.prnewswire.com/prnh/20121009/NY88522 )

"Until now, most patients in the U.S. requiring a 450mg dose of bupropion have been taking multiple tablets to achieve their dose requirement," said Douglas Saltel, President and CEO of Edgemont. "We are very pleased to be able to simplify the dosing regimen for these patients to a single Forfivo XL 450mg tablet once-daily."

Patients should use a lower dose bupropion product for therapy initiation and dose titration. Forfivo XL is only available in a 450mg dosage strength.

Bupropion HCl is marketed under several brand names and dosage forms. The original brand name products for the treatment of MDD are Wellbutrin®, Wellbutrin SR® and Wellbutrin XL®.

Please see below for Important Safety Information, including Boxed Warnings.

Important Safety Information for Forfivo XL

WARNING: SUICIDALITY and ANTIDEPRESSANT DRUGS; PSYCHIATRIC EVENTS and SMOKING CESSATION

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. 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. FORFIVO XL is not approved for use in pediatric patients.

PSYCHIATRIC EVENTS and SMOKING CESSATION: FORFIVO XL is not approved for smoking cessation treatment, but bupropion under the name ZYBAN® is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior.


CONTRAINDICATIONS

FORFIVO XL is contraindicated in:

  • Seizure disorder, because these patients may have a lower seizure threshold
  • Patients treated currently with other bupropion products, because seizure incidence is dose-dependent
  • A current or prior diagnosis of bulimia or anorexia nervosa
  • Patients undergoing abrupt discontinuation of alcohol or sedatives
  • Concurrent administration of monoamine oxidase (MAO) inhibitors. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with FORFIVO XL.
  • Known hypersensitivity to bupropion or the other ingredients of FORFIVO XL

WARNINGS AND PRECAUTIONS

Activation of Mania/Hypomania 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; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that FORFIVO XL is not approved for use in treating bipolar depression. Seizures Bupropion is associated with a dose-related risk of seizures. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications, which must be considered in selection of patients for therapy with FORFIVO XL. FORFIVO XL should be discontinued and not restarted in patients who experience a seizure while on treatment. Retrospective analysis of clinical experience gained during the development of bupropion suggests that the risk of seizure may be minimized if the total daily dose of bupropion does not exceed 450 mg and the rate of incrementation of the bupropion dose is gradual. Psychosis and Other Neuropsychiatric Events Depressed patients treated with bupropion have been reported to show a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. In some cases, these symptoms abated upon dose reduction and/or withdrawal of treatment. It is recommended stopping bupropion when the symptoms occur. Severe Hypertension In clinical practice, hypertension, in some cases severe, requiring acute treatment, has been reported in patients receiving bupropion alone and in combination with nicotine replacement therapy. These reactions have been observed in both patients with and without evidence of preexisting hypertension. Monitoring of blood pressure is recommended in patients who receive the combination of bupropion and nicotine replacement. Agitation and Insomnia Increased restlessness, agitation, anxiety, and insomnia, especially shortly after initiation of treatment, have been associated with treatment with bupropion. In clinical studies of MDD, these symptoms (see Table 2 of the full prescribing information) were sometimes of sufficient magnitude to require treatment with sedative/hypnotic drugs. Symptoms in these studies were sufficiently severe to require discontinuation of treatment in 1% and 2.6% of patients treated with 300 and 400 mg/day, respectively, of bupropion hydrochloride sustained-release tablets and 0.8% of patients treated with placebo. Altered Appetite and Weight In placebo-controlled short-term studies of MDD using the sustained-release formulation of bupropion hydrochloride, patients experienced weight gain or weight loss (see Table 3 of the full prescribing information). In studies conducted with the immediate-release formulation of bupropion hydrochloride, 35% of patients receiving tricyclic antidepressants gained weight, compared to 9% of patients treated with the immediate-release formulation of bupropion hydrochloride. If weight loss is a major presenting sign of a patient's depressive illness, the anorectic and/or weight-reducing potential of FORFIVO XL tablets should be considered. Hypersensitivity Reactions Anaphylactoid/anaphylactic reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnea requiring medical treatment have been reported in clinical trials with bupropion. In addition, there have been rare spontaneous postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock associated with bupropion. A patient should stop taking FORFIVO XL and consult a doctor if experiencing allergic or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, edema, and shortness of breath) during treatment. Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity have been reported in association with bupropion. These symptoms may resemble serum sickness [see Contraindications in the full prescribing information].

ADVERSE REACTIONS

Clinical Trials Experience: Commonly Observed Adverse Reactions in Controlled Clinical Trials The most common adverse reactions were (incidence greater than or equal to 5%; greater than or equal 2 times placebo rate): Dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, and rash.

The full prescribing information, including complete Boxed Warnings, and Medication Guide are available at www.ForfivoXL.com

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.

Wellbutrin®, Wellbutrin SR® and Wellbutrin XL® are registered trademarks of GlaxoSmithKline. Forfivo XL is a registered trademark of IntelGenx Corp.

SOURCE Edgemont Pharmaceuticals, LLC


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