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 James R.
Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We are
excited about the opportunity for OLEPTRO(TM) and are preparing the product
for launch into the $11 billion-plus U.S. antidepressant market. We are
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. Stephen Stahl, Adjunct Professor of
Psychiatry, University of California, San Diego School of Medicine. "Labopharm
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.
SOURCE Labopharm Inc.