Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced it
will have two poster presentations highlighting real-world data
from its differentiated neuropsychiatry product, Jornay PM,
(methylphenidate HCl), a central nervous system (CNS) stimulant for
the treatment of attention deficit hyperactivity disorder (ADHD) at
the National Association of Pediatric Nurse Practitioners (NAPNAP)
46th National Conference on Pediatric Health Care, being held in
Chicago, IL, from March 10-13, 2025.
“Collegium is pleased to present real-world data at NAPNAP as
part of our commitment to providing differentiated medicines that
help to improve the lives of people living with serious medical
conditions. The data being presented demonstrates the real-world
benefit of Jornay PM as an important therapeutic option for the
ADHD community,” said Thomas Smith, M.D., Chief Medical Officer of
Collegium.
The following posters will be available and on display to
attendees in Riverside Center Exhibit Hall in the East Tower during
exhibit hall hours:Monday, March 10: 12:00 pm - 1:30 pm, 6:00 pm -
7:30 pm CTTuesday, March 11: 8:00 am - 10:00 am, 12:15 pm - 2:15 pm
CT
Poster Title: |
#9: Real-World Persistence and Adherence with
Delayed-Release/Extended-Release Methylphenidate from a Large US
Claims Database Analysis |
Authors: |
Vamshi Ruthwik Anupindi, MS; Swapna Munnangi, PhD; Mitchell
DeKoven, MHSA; Michelle D. Po, PhD; Cassandra L. Uchida, PhD; Lewis
E. Warrington, MD |
|
|
Poster Title: |
#10: Real-World Utilization of Delayed-Release/Extended-Release
Methylphenidate: Demographic and Dosing Data from a Large US Claims
Database Analysis |
Authors: |
Vamshi Ruthwik Anupindi, MS; Swapna Munnangi, PhD; Mitchell
DeKoven, MHSA; Michelle D. Po, PhD; Cassandra L. Uchida, PhD; Lewis
E. Warrington, MD |
About ADHD
ADHD is among the most common childhood psychiatric conditions
with behavioral symptoms fluctuating throughout the day. It is
usually first diagnosed in childhood and often lasts into
adulthood. Children with ADHD may have trouble paying attention,
controlling impulsive behaviors, or be overly active. Many
home-based difficulties for children and adolescents with ADHD
occur during the early morning routine (e.g., before the school day
begins).
About JORNAY PM®JORNAY PM (methylphenidate HCl
extended-release capsules) is a central nervous system (CNS)
stimulant indicated for the treatment of attention deficit
hyperactivity disorder (ADHD) in patients six years and older.
|
JORNAY PM is a federally controlled substance (CII) because
it contains methylphenidate and has a high chance of abuse and
misuse and may lead to substance use problems, including
addiction. Misuse and abuse of JORNAY PM can lead to
overdose and death, which is increased with higher doses of JORNAY
PM or if it is used in ways that are not approved, such as snorting
or injection. Your healthcare provider (HCP) should check for signs
of abuse, misuse, and addiction before starting and during
treatment with JORNAY PM. JORNAY PM may lead to physical dependence
after prolonged use, even if taken as directed by your HCP. Tell
your HCP if you or your child have ever abused or been dependent on
alcohol, prescription medicines, or street drugs. |
|
IMPORTANT SAFETY
INFORMATION
Please see below for additional Important Safety
Information, including Boxed Warning and Full Prescribing
Information.
JORNAY PM can be a target for people who abuse
prescription medicines or street drugs. Keep JORNAY PM in
a safe place to protect it from theft. Never give your JORNAY PM to
anyone else, because it may cause death or harm them. Selling or
giving away JORNAY PM may harm others and is against the law.
JORNAY PM should not be taken if you or your child is
allergic to methylphenidate or any of the ingredients in
JORNAY PM or is taking or has taken an antidepressant called a
monoamine oxidase inhibitor (MAOI) within the last 14 days.
JORNAY PM may cause other serious side effects,
including:
- Risks for people with
serious heart disease. Sudden death has happened in people
who have heart defects or other serious heart disease. Your HCP
should check carefully for heart problems before starting JORNAY
PM. Tell your HCP about any heart problems, heart disease, or heart
defects. Call your HCP or go to the nearest hospital
emergency room right away if there are any signs of heart problems,
such as chest pain, shortness of breath, or fainting during
treatment.
- Increased blood pressure and
heart rate. Blood pressure and heart rate should be
checked regularly during treatment.
- Mental (psychiatric)
problems, including new or worse behavior and thought
problems; new or worse bipolar illness; new psychotic symptoms
(such as hearing voices or seeing or believing things that are not
real) or new manic symptoms. Tell your HCP about any mental
problems, or about a family history of suicide, bipolar illness, or
depression. Call your HCP right away if there are any new
or worsening mental symptoms or problems during
treatment.
- Painful and prolonged
erections (priapism) in males. If painful and prolonged
erections happen, get medical help right away.
- Circulation problems in
fingers and toes (peripheral vasculopathy, including Raynaud’s
phenomenon). Signs and symptoms may include fingers or
toes feeling numb, cool, painful, sensitive to temperature, and/or
changing color from pale, to blue, to red. Tell your HCP about any
circulation problems in fingers or toes. Call your HCP
right away if any signs of unexplained wounds appear on fingers or
toes.
- Slowing of growth (height
and weight) in children. Children should have their height
and weight checked often while taking JORNAY PM.
- Eye problems (increased
pressure in the eye and glaucoma). Tell your HCP about any
eye problems. Call your HCP right away if changes in vision or eye
pain, swelling, or redness occurs.
- New or worsening tics or
worsening Tourette’s syndrome. Tell your HCP if any new or
worsening tics or worsening Tourette’s syndrome occurs.
Before taking JORNAY PM, tell your HCP if you or your
child:
- are pregnant or plan to become
pregnant. It is not known if JORNAY PM will harm an unborn
baby.
- are breastfeeding or plan to
breastfeed. JORNAY PM passes into the breast milk.
Tell your HCP about all of the medicines that you or your child
takes, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. JORNAY PM and some medicines may
interact with each other and cause serious side effects. Especially
tell your HCP if you or your child takes medicine to treat
depression, including MAOIs.Avoid drinking alcohol during treatment
with JORNAY PM. This may cause a faster release of the medicine in
JORNAY PM.
The most common side effects of methylphenidate
include decreased appetite, stomach pain, irritability,
trouble sleeping, weight loss, mood swings (affect lability),
nausea, anxiety, increased heart rate, vomiting, dizziness,
increased blood pressure, and indigestion.
The most common side effects of JORNAY PM in clinical
studies in children ages 6 to 12 with ADHD include trouble
sleeping, nausea, decreased appetite, mood swings, restlessness
(psychomotor hyperactivity), vomiting, and headache. These are not
all the possible side effects of JORNAY PM.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call
1-800-FDA-1088.
What is JORNAY PM?
JORNAY PM is a central nervous system (CNS) stimulant
prescription medicine used for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in people 6 years of age and older.
JORNAY PM may help increase attention and decrease impulsiveness
and hyperactivity in people 6 years of age and older with ADHD. It
is not known if JORNAY PM is safe and effective in children under 6
years of age.
Please see Medication Guide
and full Prescribing
Information, including Boxed
Warning
About Collegium Pharmaceutical, Inc.
Collegium is building a leading, diversified biopharmaceutical
company committed to improving the lives of people living with
serious medical conditions. The Company has a leading portfolio of
responsible pain management medications and recently acquired
Jornay PM, a treatment for ADHD, establishing a presence in
neuropsychiatry. Collegium’s strategy includes growing its
commercial portfolio, with Jornay PM as the lead growth driver, and
deploying capital in a disciplined manner. Collegium’s headquarters
are located in Stoughton, Massachusetts. For more information,
please visit the Company’s website at www.collegiumpharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. We may, in some
cases, use terms such as "predicts," "forecasts," "believes,"
"potential," "proposed," "continue," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "should" or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Examples of
forward-looking statements contained in this press release include,
among others, statements related to future market opportunities for
our products and our assumptions related thereto, expectations
(financial or otherwise) and intentions, and other statements that
are not historical facts. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results, performance, or achievements to differ
materially from the company's current expectations, including risks
relating to, among others: unknown liabilities; risks related to
future opportunities and plans for our products, including
uncertainty of the expected financial performance of such products;
our ability to commercialize and grow sales of our products; our
ability to realize the anticipated benefits associated with the
acquisition of Ironshore; our ability to manage our
relationships with licensors; the success of competing products
that are or become available; our ability to maintain regulatory
approval of our products, and any related restrictions,
limitations, and/or warnings in the label of our products; the size
of the markets for our products, and our ability to service those
markets; our ability to obtain reimbursement and third-party payor
contracts for our products; the rate and degree of market
acceptance of our products; the costs of commercialization
activities, including marketing, sales and distribution; changing
market conditions for our products; the outcome of any patent
infringement or other litigation that may be brought by or against
us; the outcome of any governmental investigation related to our
business; our ability to secure adequate supplies of active
pharmaceutical ingredient for each of our products and manufacture
adequate supplies of commercially saleable inventory; our ability
to obtain funding for our operations and business development;
regulatory developments in the U.S.; our expectations
regarding our ability to obtain and maintain sufficient
intellectual property protection for our products; our ability to
comply with stringent U.S. and foreign government
regulation in the manufacture of pharmaceutical products,
including U.S. Drug Enforcement Agency (DEA), compliance; our
customer concentration; and the accuracy of our estimates regarding
expenses, revenue, capital requirements and need for additional
financing. These and other risks are described under the heading
"Risk Factors" in our Annual Reports on Form 10-K and Quarterly
Reports on Form 10-Q and other filings with the SEC. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
Investor Contacts:Ian KarpVice President,
Investor Relationsir@collegiumpharma.com
Danielle JesseDirector, Investor
Relationsir@collegiumpharma.com
Media Contact:Cheryl WheelerHead of Corporate
Communicationscommunications@collegiumpharma.com
Grafico Azioni Collegium Pharmaceutical (NASDAQ:COLL)
Storico
Da Feb 2025 a Mar 2025
Grafico Azioni Collegium Pharmaceutical (NASDAQ:COLL)
Storico
Da Mar 2024 a Mar 2025