EXXUA is the first new chemical entity (NCE) utilizing this
single mechanism approved for the treatment of major depressive
disorder.
EXXUA's approved labeling does not list sexual dysfunction as
an adverse reaction.
HOUSTON, Sept. 28,
2023 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals
Inc. (Fabre-Kramer), a biopharmaceutical company committed to
developing novel therapies to address unmet needs in psychiatry and
neurology, is pleased to announce that the U.S. Food and Drug
Administration (FDA) has approved Exxua™ (gepirone hydrochloride
extended-release tablets) for the treatment of major depressive
disorder (MDD) in adults. Exxua represents a new class of
antidepressant; the first and only approved antidepressant with a
novel mechanism of action that selectively targets the serotonin 1A
receptor, a key regulator of mood and emotion. Exxua has been shown
to effectively relieve depressive symptoms, and its approved
labeling does not contain Warnings or Adverse Reactions regarding
causing sexual dysfunction or weight gain vs. placebo. Exxua is
expected to be available in pharmacies in early 2024.
Studied in over 5,000 patients, EXXUA's unique mechanism of
targeted single serotonin (5HT) 1a receptor agonism relieves
depressive symptoms with an acceptable side effect profile. Sexual
side effects experienced with EXXUA treatment in clinical trials
were comparable to placebo and did not meet the incidence criteria
for inclusion in the Adverse Reaction section of EXXUA's label.
EXXUA also showed an overall acceptable safety profile, with no
significant adverse effect on weight, blood pressure, heart rate or
liver function. The most frequent adverse events seen in clinical
trials were dizziness and nausea, which generally were mild, of
short duration, related to dose escalations and did not require
discontinuation of treatment.
Anita H. Clayton, MD, Chair,
Department of Psychiatry & Neurobehavioral Sciences,
University of Virginia School of
Medicine, a renowned clinician and researcher of sexual dysfunction
issues in MDD treatment commented "I am thrilled for our patients
that EXXUA (gepirone ER) is now FDA approved for the treatment of
major depressive disorder (MDD). EXXUA is the first 5-HT1a agonist
with superior efficacy vs. placebo as MDD monotherapy, yet did not
differ from placebo in rates of sexual dysfunction in clinical
trials. This provides an important new treatment option for
patients."
"EXXUA represents an important milestone in the treatment of
MDD, a serious and debilitating condition that affects millions of
people worldwide," said Stephen
Kramer, M.D., CEO of Fabre-Kramer. "There is value in
providing prescribers and patients with a wide range of effective
options for use in clinical practice. We are proud to bring this
innovative therapy to patients who need a new option to manage
their depression and improve their quality of life."
Michael Pollack, Chief Executive
Officer of the Depression and Bipolar Support Alliance (DBSA), a
leading national patient advocacy organization said "The mental
health crisis in the United States
is one of the most pressing health issues facing our country today.
Over 20 million American adults experienced major depressive
disorder each year prior to the COVID-19 pandemic. These numbers
increased dramatically during the pandemic with approximately 30%
of adults in the US or more than 80 million Americans experiencing
elevated symptoms of depression. The need for new treatment
options, particularly those with new mechanisms of action, could
not be clearer and more urgent for those living with, or impacted
by, major depressive disorder."
The mechanism of the antidepressant effect of EXXUA is not fully
understood but is believed to be related to its modulation of
serotonin activity in the CNS through selective agonist activity at
5HT1a receptors. EXXUA and its active metabolite exhibit exclusive
and strong binding affinity for 5HT1a receptors. Dr. Stephen Stahl, Professor of Psychiatry,
University of California and founder of
the Neuroscience Education Institute, a recognized expert
neuropsychopharmacologist said "EXXUA is the first truly selective
agonist of the serotonin 1a receptor that has been consistently
linked to mediation of mood disorders and suicide risk. It's an
important addition to the armamentarium to treat depression."
About EXXUA
EXXUA is a novel oral selective serotonin (5HT) 1a receptor
agonist indicated for the treatment of major depressive disorder
(MDD) in adults. Exxua is also being developed for other
psychiatric disorders.
INDICATIONS and IMPORTANT SAFETY INFORMATION for
EXXUA (gepirone) extended-release tablets
INDICATIONS
EXXUA is indicated for the treatment of major depressive
disorder (MDD) in adults.
IMPORTANT SAFETY INFORMATION
- Antidepressants increased the risk of suicidal thoughts and
behaviors in pediatric and young adult patients in short-term
studies. Closely monitor all antidepressant-treated patients for
clinical worsening and emergence of suicidal thoughts and
behaviors.
- EXXUA is not approved for use in pediatric
patients.
Do not take EXXUA if you:
- are allergic to EXXUA or any of the ingredients in EXXUA. See
the end of this Medication Guide for a complete list of ingredients
in EXXUA.
- have a prolonged QTc interval greater than 450 msec or
congenital long QT syndrome.
- are taking medicines known as strong CYP3A4 inhibitors. Ask
your healthcare provider if you are not sure if you are taking one
of these medicines.
- have severe liver problems.
- are taking, or have stopped taking within the last 14 days, a
medicine called a monoamine oxidase inhibitor (MAOI), including the
antibiotic linezolid or intravenous methylene blue. Ask your
healthcare provider or pharmacist if you are not sure if you take
an MAOI, including the antibiotic linezolid or intravenous
methylene blue.
- Do not start taking an MAOI for at least 14 days after you have
stopped treatment with EXXUA.
EXXUA may cause serious side effects, including:
- Changes in the electrical activity of your heart called QT
prolongation. QT prolongation can cause irregular heartbeats
that can be life-threatening or lead to death. Your healthcare
provider will check the electrical activity of your heart with a
test called an electrocardiogram (ECG) and will also do blood tests
to check your levels of body salts (electrolytes) before and during
treatment with EXXUA. Your healthcare provider may check your
electrolytes more often during treatment if you have heart failure,
a slow heart rate, abnormal levels of electrolytes in your blood,
or if you take a medicine that can prolong the QT interval of your
heartbeat. Tell your healthcare provider right away if you have an
irregular heartbeat or feel dizzy, lightheaded, or faint during
treatment with EXXUA.
- Serotonin syndrome. A potentially life-threatening
problem called serotonin syndrome can happen when EXXUA is taken
with certain other medicines.
- Manic episodes. Manic episodes may happen in people with
bipolar disorder who take EXXUA.
Please read FULL PRESCRIBING INFORMATION
and MEDICATION GUIDE for EXXUA.
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 in the therapeutic areas of psychiatry and
neurology. The Company focuses on compounds to license-in, develop
for global registration, and license-out to commercial
partners.
Follow us on social media - LinkedIn
Visit our
website at www.fabrekramer.com
Contact –
info@fabrekramer.com
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SOURCE Fabre-Kramer Pharmaceuticals, Inc.
