Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, announces the
presentation of two posters at Psych Congress 2023 with new data
showing improved efficacy in children ages 6 years and older with
ADHD when Qelbree is added to a stimulant, as well as in adults
with ADHD who undergo long-term treatment with Qelbree.
“While ADHD is recognized as one of the most
common psychiatric diagnoses, affecting approximately 16.1 million
individuals in the United States, patients are in need of
alternative or additional options to stimulants that allow them to
manage their symptoms with a safe and tolerable treatment option,”
says Jonathan Rubin, Chief Medical Officer and Senior Vice
President of Research & Development. “The new Qelbree data
presented during Psych Congress 2023 reinforce the efficacy and
safety of our novel nonstimulant treatment in addition to existing
stimulant therapy in children ages 6 and older with ADHD and in a
long-term setting in adults with ADHD.”
Results from Phase IV Safety Trial of
Concomitant Use with Psychostimulants in Children and Adolescents
with ADHD
When added to existing psychostimulants, Qelbree
demonstrated a favorable safety and tolerability profile as well as
a significant improvement in ADHD symptoms in pediatric patients
(6-17 years), regardless of timing of dosing.
In an eight-week, Phase IV, open-label study,
children (ages 6-11) and adolescents (ages 12-17) took
psychostimulants at least five days a week in the morning
throughout the duration of the study, and received Qelbree
once-daily in the morning through week four and then switched to
evening dosing through week eight; children received 100mg per day
of Qelbree at week one and were optimized to 100-400mg per day, and
adolescents received 200mg per day of Qelbree at week one and were
optimized to 200-600mg per day.
Results showed significant symptom improvement
from baseline ADHD-RS-5 and CGI-S scores following both morning and
evening dosing of Qelbree in combination with the morning
psychostimulant. At baseline (N=56), mean (standard deviation)
ADHD-RS-5 and CGI-S scores were 37.2 (8.35) and 4.4 (0.56),
respectively, and improved at week four (N=54) by -13.5 (9.7) and
-0.9 (0.92), respectively, and at week eight (N=48) by -18.2 (9.99)
and -1.4 (1.10), respectively. Reported adverse events (AEs) of the
combination therapy included headache (17.9%), decreased appetite
(12.5%), and upper respiratory tract infection (10.7%), and 3.6% of
patients discontinued the combination treatment due to an AE.
“Approximately 10%-30% of individuals living
with ADHD experience inadequate response or have difficulty
tolerating stimulant medications, which indicates a clear need for
alternative or additional treatment options,” says Ann Childress,
M.D., President of the Center for Psychiatry and Behavioral
Medicine in Las Vegas, NV. “These data demonstrate Qelbree’s
ability to enhance efficacy when co-administered with stimulants,
including significant improvement during evening hours when the
effects of stimulants often wear off following their morning dose.
This study illustrates the versatility of Qelbree to address
patient needs, including standalone usage and combination therapy,
regardless of dosing time.”
Final Results from Long-term, Phase III,
Open-label Extension Trial in Adults with ADHD
Conclusive outcomes from a long-term, open-label
extension (OLE) trial of the double-blind pivotal Phase III study
that led to the U.S. Food and Administration (FDA)-approval of
Qelbree in adults with ADHD, found that adult patients (N=159) saw
an improvement in ADHD symptoms and executive function with safety
and tolerability similar to the initial trial.
Adults received 200mg of Qelbree every day for
one week, increased to 400mg, and then optimized over twelve weeks
up to 600mg per day (200-600mg per day). Patients in this
open-label trial received Qelbree for 265 (254.9) days.
Patients ADHD symptoms improved from 37.9 (6.34)
to 19.7 (12.16) on the Adult ADHD Investigator Symptom Rating Scale
(AISRS), representing average symptom reduction of -18.2 (11.54).
Patients executive function improved from 70.4 (10.94) to 58.3
(16.19) on the BRIEF-A Global Executive Composite scale,
representing improvement in executive function of -12.9 (13.48).
The treatment related adverse events (TRAEs) seen in this long-term
trial were consistent with those seen in the short-term pivotal
adult trial. The most commonly occurring TRAEs reported with the
use of Qelbree were insomnia (11.3%), nausea (9.4%), headache
(5.7%), and fatigue (10.1%). AEs led to discontinuation in 17.6% of
patients.
“ADHD is a 24/7 disorder that often persists
into adulthood, and it can be difficult to find the right treatment
regimen,” says Andrew J. Cutler, M.D., Clinical Associate Professor
of Psychiatry at SUNY Upstate Medical University, and Chief Medical
Officer, Neuroscience Education Institute. “These data are
encouraging as they underscore the compelling advantage of
long-term medication adherence and benefits with Qelbree for our
ADHD patients, including sustained improvement in ADHD symptoms,
robust response, reduced severity and improved executive
function.”
INDICATION
Qelbree® (viloxazine extended-release capsules) is a
prescription medicine used to treat ADHD in adults and children 6
years and older.
IMPORTANT SAFETY INFORMATION ABOUT
QELBREEQelbree may increase suicidal thoughts and
actions, in children and adults with ADHD, especially within the
first few months of treatment or when the dose is
changed. Tell your doctor if you or your
child have (or if there is a family history of) suicidal thoughts
or actions before starting Qelbree. Monitor your or your child’s
moods, behaviors, thoughts, and feelings during treatment with
Qelbree. Report any new or sudden changes in these symptoms right
away.
You should not take Qelbree if you or your
child:Take a medicine for depression called a monoamine
oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past
14 days. Also, you or your child should avoid alosetron,
duloxetine, ramelteon, tasimelteon, tizanidine, and
theophylline.
Qelbree can increase blood pressure and heart
rate. Your or your child’s doctor will monitor these vital
signs.
Qelbree may cause manic episodes in patients with
bipolar disorder. Tell your doctor if you or your child
show any signs of mania.
Do not drive or operate heavy machinery until you know
how Qelbree will affect you or your child. Qelbree may
cause you or your child to feel sleepy or tired.
The most common side effects of
Qelbree in patients 6 to 17 years are sleepiness, not
feeling hungry, feeling tired, nausea, vomiting, trouble sleeping,
and irritability, and in adults, insomnia, headache, sleepiness,
tiredness, nausea, decreased appetite, dry mouth, and constipation.
These are not all the possible side effects of Qelbree.
Please see full Prescribing Information, including Boxed
Warning, for Qelbree here.
About Supernus Pharmaceuticals,
Inc.
Supernus Pharmaceuticals is a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes
approved treatments for epilepsy, migraine, ADHD, hypomobility in
Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea,
dyskinesia in PD patients receiving levodopa-based therapy, and
drug-induced extrapyramidal reactions in adult patients. We are
developing a broad range of novel CNS product candidates including
new potential treatments for hypomobility in PD, epilepsy,
depression, and other CNS disorders.
For more information, please visit
www.supernus.com.
Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements do not convey historical
information but relate to predicted or potential future events that
are based upon management's current expectations. These statements
are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by
such statements. In addition to the factors mentioned in this press
release, such risks and uncertainties include, but are not limited
to, the Company’s ability to sustain and increase its
profitability; the Company’s ability to raise sufficient capital to
fully implement its corporate strategy; the implementation of the
Company’s corporate strategy; the Company’s future financial
performance and projected expenditures; the Company’s ability to
increase the number of prescriptions written for each of its
products; the Company’s ability to increase its net revenue; the
Company’s ability to commercialize its products including Qelbree;
the Company’s ability to enter into future collaborations with
pharmaceutical companies and academic institutions or to obtain
funding from government agencies; the Company’s product research
and development activities, including the timing and progress of
the Company’s clinical trials, and projected expenditures; the
Company’s ability to receive, and the timing of any receipt of,
regulatory approvals to develop and commercialize the Company’s
product candidates; the Company’s ability to protect its
intellectual property and operate its business without infringing
upon the intellectual property rights of others; the Company’s
expectations regarding federal, state and foreign regulatory
requirements; the therapeutic benefits, effectiveness and safety of
the Company’s product candidates; the accuracy of the Company’s
estimates of the size and characteristics of the markets that may
be addressed by its product candidates; the Company’s ability to
increase its manufacturing capabilities for its products and
product candidates; the Company’s projected markets and growth in
markets; the Company’s product formulations and patient needs and
potential funding sources; the Company’s staffing needs; and other
risk factors set forth from time to time in the Company’s filings
with the Securities and Exchange Commission made pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934, as
amended. The Company undertakes no obligation to update the
information in this press release to reflect events or
circumstances after the date hereof or to reflect the occurrence of
anticipated or unanticipated events.
CONTACT:
Jack A. Khattar, President and CEO Timothy C.
Dec, Senior Vice President and CFOSupernus Pharmaceuticals,
Inc.Tel: (301) 838-2591
Or
MEDIA CONTACT:Alice
SofieldMobile: (703) 861-5654Email:
Alice.Sofield@BCW-Global.com
INVESTOR CONTACT:Peter VozzoICR
WestwickeOffice: (443) 213-0505Email: peter.vozzo@westwicke.com
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