BRIDGEWATER, N.J., April 7 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced today that Aplenzin(TM) (bupropion hydrobromide) extended-release tablets, an effective bupropion therapy for the treatment of major depressive disorder (MDD), is now available by prescription in the United States for adults ages 18 and older. Aplenzin differs from other generic and branded bupropion antidepressants because it provides a unique HBr salt extended-release formulation, offering prescribers and their patients the benefit of convenience with simple one tablet, once-daily dosing at all doses.
"For patients who show little clinical improvement on lower doses of bupropion, there is a need to take higher doses to treat major depressive disorder," said Prakash Masand, M.D., Consulting Professor of Psychiatry and Behavioral Sciences,
For those patients in whom no clinical improvement is noted after several weeks of treatment at the target dose of 348 mg per day, Aplenzin offers physicians and their patients the ability to titrate up to the 522 mg strength. The Aplenzin 522 mg dose is the only FDA-approved single-tablet, once daily treatment equivalent to 450 mg of bupropion HCl therapy, requiring two or three tablets daily.
"With major depressive disorder affecting about 14 million Americans, we are excited to offer patients an effective treatment option that hopefully addresses existing unmet needs," said Brent Ragans, Vice President and Head of the General Therapeutics Business Unit, sanofi-aventis.
Bupropion, the active ingredient in Aplenzin, offers comparable efficacy to fluoxetine, an SSRI. Bupropion also has low incidence of weight gain compared to placebo. Research suggests that MDD may be caused by an imbalance of brain chemicals called neurotransmitters. The mechanism of action of Aplenzin is unknown; however, it is believed that bupropion, the active ingredient of Aplenzin, may help restore the balance of neurotransmitters, by inhibiting the reuptake of norepinephrine and dopamine.
Aplenzin was approved by the U.S. Food and Drug Administration (FDA) in April 2008. Sanofi-aventis U.S., which licensed Aplenzin from Biovail Corporation in December 2008, markets the product in the United States and Puerto Rico.
About Major Depressive Disorder
In the United States, it is estimated that between 10 percent and 25 percent of women and five percent and 12 percent of men will experience a major depressive episode at some point in their lives. Unlike normal emotional experiences of sadness, loss or passing mood states, MDD is persistent (it may last, on average, up to 16 weeks) and is usually associated with substantial symptom severity and role impairment, contributing to reduced productivity. According to one study, people with MDD reported an average of 35 days in the past year when they were unable to work or carry out their normal activities. MDD is associated with comorbid anxiety and substance abuse, and evidence suggests it is a significant risk factor for stroke, hypertension, heart disease, and death due to heart attack. The costs associated with MDD are greater than those from hypertension and equivalent to those of heart disease, diabetes and back problems combined.
Research shows that only 57 percent of patients with MDD are treated for depression in the primary care setting each year, with only one in five of these patients receiving adequate treatment. The most common treatments for MDD are antidepressants and psychotherapy.
APLENZIN is indicated for the treatment of major depressive disorder in adults aged 18 years and older.
Important Safety Information:
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 APLENZIN 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. APLENZIN is not approved for use in pediatric patients.
APLENZIN is contraindicated in patients who have a seizure disorder, patients being treated with Zyban(R) (bupropion HCl) Sustained-Release Tablets, WELLBUTRIN(R) (bupropion HCl), WELLBUTRIN SR(R) (bupropion HCl) Sustained-Release Tablets, or any other medications that contain bupropion, patients who have or had bulimia or anorexia nervosa, patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines), patients who have shown an allergic response to bupropion and patients taking MAO inhibitors. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of APLENZIN.
Physicians should be aware that bupropion is associated with a risk of seizure, which is dose related. The incidence of seizure may be similar to that of the sustained-release formulations of bupropion, since APLENZIN has demonstrated bioequivalence. To reduce the risk of seizures, please see WARNINGS and PRECAUTIONS in the Prescribing Information for patient selection considerations, including concomitant medications and dosing recommendations.
Physicians, families, and caregivers should monitor patients for suicidality as well as anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, and other unusual changes in behavior. All patients should be closely monitored for these symptoms, especially at the beginning of therapy, or with changes in dose and reported immediately to the patient's healthcare provider. Please consult prescribing information for APLENZIN for additional monitoring recommendations. There is concern that such symptoms may be precursors to suicidality, although a causal link has not been proven. If such symptoms occur, prescribers should consider changing or discontinuing treatment. Patients should be screened for bipolar disorder prior to initiating treatment with an antidepressant.
When treating patients with severe hepatic cirrhosis, extreme caution should be exercised, and a reduced dosage and/or frequency is required to avoid accumulation. Increased restlessness, agitation, anxiety, and insomnia, especially shortly after initiation of treatment, have been associated with treatment with bupropion. Neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion have been reported with bupropion. Anaphylactoid reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnea requiring medical treatment have been reported in clinical trials with bupropion. There have been reports of hypertension, in some cases severe, in patients receiving bupropion alone and in combination with nicotine replacement therapy.
The most common adverse reactions reported are dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency and rash. Please see the full prescribing information for additional safety information.
The full prescribing information is available at www.aplenzin.com.
Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
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