SILVER SPRING, Md. and HOUSTON, Dec. 2,
2015 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals, Inc.
announced today that the U.S. Food and Drug Administration's (FDA)
Psychopharmacologic Drugs Advisory Committee (PDAC) completed its
review of gepirone ER for the treatment of major depressive
disorder (MDD) and that the input from the committee will be
considered by Dr. John Jenkins, the
Director of the Office of New Drugs at the Center for Drug
Evaluation and Research at FDA. Fabre-Kramer remains cautiously
optimistic based on the discussion at the PDAC today.
Dr. Lisa LaVange, Director of the
Office of Biostatistics at the FDA's Center for Drug Evaluation and
Research, presented an assessment in the meeting that is consistent
with Fabre-Kramer's – that gepirone has demonstrated substantial
evidence of effectiveness. It was also echoed by several panel
members who possess extensive experience in depression.
The advisory committee as a whole expressed overwhelming support
for the safety of the product. In addition, the current standing
members of PDAC, as well as the acting chairman, voted favorably
regarding the benefit risk of gepirone in the treatment of MDD.
"We are encouraged by the universal agreement by the FDA and
PDAC that there are two adequate, well-controlled studies
supporting the effectiveness of this product, and by Dr. LaVange's
conclusion that the totality of the evidence also supports
effectiveness," said Dr. Stephen J.
Kramer, CEO of Fabre-Kramer. "We're optimistic the FDA will
determine gepirone to be effective, as they have done for all other
products in this class with two positive studies."
There were multiple pleas for broader access to antidepressant
options during the Committee's Open Public Session, and recognition
of the need for new treatments for the millions of patients with
debilitating depression for whom current medications are
inadequate.
"Gepirone ER is a drug with a novel mechanism that promises to
work for patients where other drugs don't," said Dr. Stephen Stahl, Professor of Psychiatry,
University of California and founder of
the Neuroscience Education Institute.
During the discussion, certain committee members suggested the
potential need for a third positive study, beyond the traditional
standard for approval of drugs, to counterbalance the number of
failed/negative studies and provide further reassurance of the
drug's efficacy.
"There's more at stake here than just gepirone," commented Dr.
Stahl. "The larger concern is that if the FDA does not approve this
drug, it will discourage companies from trying to create new
psychiatric drugs, which many companies already avoid because of
the high failure rate. It could have a chilling effect on future
development in this class."
"We await the decision of the FDA, and remain hopeful they will
conclude gepirone ER has demonstrated substantial evidence of
effectiveness, clearing the way for the availability of this new
treatment for MDD for the benefit of both patients and physicians,"
said Dr. Kramer.
About Gepirone ER
Although some effective treatment options exist for adults with
MDD, drugs such as SSRIs and SNRIs are not always optimal since
they are often associated with side effects such as sexual
dysfunction that limit their use. Gepirone ER has been shown to
effectively treat the disorder without causing sexual dysfunction
and with fewer side effects than other antidepressants including
transient lightheadedness and nausea.
About Fabre-Kramer
Fabre-Kramer is committed to developing and bringing to market
advanced new medications to help physicians treat their patients
unmet medical needs. The company's leadership has a long history in
clinical research and an impressive track record of the clinical
development of more than 17 psychiatric drugs approved in the
U.S.
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SOURCE Fabre-Kramer Pharmaceuticals, Inc.