Labopharm Receives FDA Approval For OLEPTRO(TM)
Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug
Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride)
Extended Release Tablets, a novel once-daily formulation of the antidepressant
trazodone, for the treatment of major depressive disorder (MDD) in adults.
OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm’s clinically validated technology
that controls the release of active substances within oral medications.
“OLEPTRO(TM) represents Labopharm’s second CONTRAMID(R) technology-based
product to receive FDA approval in just over a year,” said
excited about the opportunity for OLEPTRO(TM) and are preparing the product
for launch into the
working towards finalizing a commercialization path for OLEPTRO(TM) that will
maximize the value of our product in this market.”
MDD is a common mental illness often characterized by a combination of
social and somatic symptoms. It affects more than 14 million adults in the
U.S. and is the leading cause of disability globally. OLEPTRO(TM) will offer
physicians another therapeutic alternative for their MDD patients.
“There’s a large body of evidence demonstrating the efficacy of trazodone
in the treatment of MDD,” said Dr.
has developed a novel formulation of trazodone that effectively treats
depression and provides a tolerable adverse event profile.”
Labopharm is actively exploring several alternatives for the U.S.
commercialization of OLEPTRO(TM). Such alternatives range from out-licensing
the product to a distribution partner while retaining the right to some degree
of co-promotion, through to a full co-promotion arrangement under which
Labopharm would share the sales function with a partner. The Company currently
expects to finalize the commercialization plan for OLEPTRO(TM) in the near
Labopharm expects OLEPTRO(TM) to be available for prescription in the U.S.
later this year, with specific timing for its launch to be determined within
the context of the final commercialization plan. The Company believes it is
well advanced in its preparations for the U.S. launch of OLEPTRO(TM). The
Company has completed market research with physicians and third-party payors,
developed a positioning and marketing campaign for OLEPTRO(TM), and finalized
product manufacturing and packaging arrangements.
About the OLEPTRO(TM) Pivotal Study
An eight-week randomized, double-blind, two-arm, multi-centre study in
patients with unipolar major depressive disorder demonstrated OLEPTRO(TM)’s
efficacy as a treatment for depression. The primary efficacy endpoint of the
study was to compare the change in the Hamilton Rating Scale for Depression
(HAMD-17) total score from baseline to the end of the study in the OLEPTRO(TM)
group versus the placebo group. The results of this study, which are published
- Statistical significance was achieved for the primary endpoint (p value of 0.012). - The overall discontinuation rate in the study was 25 percent with 21 percent in the placebo group and 30 percent in the OLEPTRO(TM) group. - In the OLEPTRO(TM) group, four percent of patients discontinued treatment due to somnolence or sedation.
“Our research in the clinical study leading up to FDA approval showed that
OLEPTRO(TM) was well-tolerated and demonstrated a significantly greater
improvement in the HAMD-17 primary efficacy end point over placebo,” said Dr.
Anxiety Disorders Research Institute,
Medicine. “When given at the recommended daily dose range, OLEPTRO(TM) was an
appropriate monotherapy for patients with MDD.”
Labopharm will conduct a post-approval pediatric study. The FDA has asked
Labopharm to provide data from a long-term maintenance study and an additional
in-vitro alcohol dissolution study.
About Major Depressive Disorder
Approximately two times more prevalent in women than men, MDD often
co-exists with other illnesses. Research shows that only approximately 65
percent of individuals with MDD are diagnosed and, of those patients, 90
percent are treated with medication.
Treating MDD with antidepressant medications is challenging for physicians
because patient response to antidepressant drug therapy varies significantly.
Research has shown that as many as 28 percent of patients being treated with
antidepressants stop taking their medication within the first four weeks of
treatment and as many as 44 percent stop within the first 12 weeks. Reasons
for discontinuing antidepressant treatment can include suboptimal efficacy,
the exacerbation of symptoms such as sleep disturbance, agitation, and sexual
dysfunction, and adverse events such as weight gain.
The FDA’s decision represents the first regulatory approval for
Labopharm’s novel, once-daily formulation of trazodone. The formulation is
currently under regulatory review in
Important Safety Information About Treatment with OLEPTRO(TM)
For more complete information about the use of OLEPTRO(TM), please see the
FDA-approved Prescribing Information and Medication Guide which will be posted
on the FDA website (http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/).
Black Box Warning Warning: Suicidality and Antidepressant Drugs See full prescribing information for complete boxed warning Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. OLEPTRO(TM) is not approved for use in pediatric patients. Warning and Precautions - Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behaviour, or unusual change in behaviour, whether or not they are taking antidepressant medications. Patients should be monitored for clinical worsening and suicidality and for the appearance of any of the following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Families and caregivers should be alerted about the need to monitor patients. - The development of a potentially life-threatening serotonin syndrome, or neuroleptic malignant syndrome (NMS)-like reactions has been reported with antidepressants, and may occur with OLEPTRO(TM), particularly with concomitant use of other serotoninergic drugs. Treatment with OLEPTRO(TM) and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately and supportive treatment should be initiated. - A major depressive episode may be the initial presentation of bipolar disorder. Prior to initiating treatment, patients should be adequately screened to determine if they are at risk for bipolar disorder and monitored for mania/hypomania. OLEPTRO(TM) is not approved for use in treating bipolar depression. - Experience with administration of immediate-release trazodone products indicates that there may be an increased risk for QT interval prolongation. QT prolongation may lead to Torsades de pointes and even death especially in susceptible individuals, such as those with hypokalemia, hypomagnesemia, or a genetic predisposition to prolonged QT/QTc. - Patients with pre-existing cardiac disease may be at more risk for arrythmias. Concomitant administration of drugs that prolong the QT interval or that are inhibitors of CYP3A4 may increase the risk of cardiac arrhythmia in these patients. - Orthostatic hypotension and syncope have been reported in patients receiving trazodone hydrochloride. - Drugs that interfere with serotonin reuptake, including trazodone hydrochloride may increase the risk of bleeding events. Concomitant use with NSAIDs, aspirin, or other drugs that affect coagulation may compound this risk. - Serious, sometimes fatal, reactions have been reported when serotonergic drugs are used in combination with monoamine oxidase inhibitor(s). Therefore, OLEPTRO(TM) should not be used concomitantly or within 14 days of monoamine oxidase inhibitors. - Rarely, cases of priapism can occur in men receiving trazodone. OLEPTRO(TM) should be used with caution in men who have predisposing conditions. - There is a risk of hyponatremia when taking antidepressants. Elderly patients may be at greater risk, as well as patients taking diuretics or who are volume-depleted. - OLEPTRO(TM) has the potential to impair judgment, thinking, and motor skills. Advise patients to use caution before driving and when operating machinery. - Discontinuation symptoms may occur with abrupt discontinuation, and may include anxiety, agitation and sleep disturbance. Upon discontinuation, taper OLEPTRO(TM) and monitor for symptoms. Adverse Reactions
The most common adverse reactions (incidence greater than or equal to five
percent and twice that of placebo) are: somnolence/sedation, dizziness,
constipation, blurred vision.
These are not all the possible adverse events of OLEPTRO(TM). About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing
small molecule drugs using its proprietary controlled-release technologies.
The Company’s lead product, a unique once-daily formulation of tramadol, is
now available in 17 countries around the world, including the U.S.,
major European markets and
formulation of trazodone for the treatment of major depressive disorder in
adults, has received regulatory approval in the U.S. and is under regulatory
process for its third product, a twice-daily formulation of
tramadol-acetaminophen. The Company also has a pipeline of follow-on products
in both pre-clinical and clinical development. Labopharm’s vision is to become
an integrated, international, specialty pharmaceutical company with the
capability to internally develop and commercialize its own products. For more
information, please visit www.labopharm.com.
This press release contains forward-looking statements, including
statements concerning the market opportunity for OLEPTRO(TM), statements
concerning partnering discussions and commercialization plan for OLEPTRO(TM),
and statements concerning the Company’s pipeline of product candidates, which
reflect the Company’s current expectations regarding future events. These
forward-looking statements involve risks and uncertainties, many of which are
beyond the Company’s control. Actual events could differ materially from those
projected herein and depend on a number of risks and uncertainties, including
risks related to the Company’s ability to complete a partnering transaction
and the terms of any such collaboration, if any, risks related to the market
acceptance of the Company’s products and the speed of adoption by clinicians,
risks related to intellectual property protection and potential infringement
of third-party rights, risks related to research and development of
pharmaceutical products and regulatory approvals, and risks associated with
intense competition in the pharmaceutical industry generally. For additional
disclosure regarding these and other risks faced by Labopharm Inc., see the
disclosure contained in its public filings in the U.S. with the Securities and
Exchange Commission (SEC) and in
Administrators (CSA), available on the Investor Relations section of the
Company’s website at www.labopharm.com and on the SEC’s website at www.sec.gov
and on the CSA’s website at www.sedar.com. Investors are cautioned not to
place undue reliance on these forward-looking statements. Unless required by
law, the Company undertakes no obligation to update or revise the information
contained in this press release, whether as a result of new information,
future events, or circumstances or otherwise.
OLEPTRO(TM) is a trademark of Labopharm Inc. CONTRAMID(R) is a registered trademark of Labopharm Inc.
SOURCE Labopharm Inc.