STOUGHTON, Mass., March 10, 2025 (GLOBE NEWSWIRE) — 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 CT
Tuesday, 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 Statements
This 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 Karp
Vice President, Investor Relations
[email protected]
Danielle Jesse
Director, Investor Relations
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Media Contact:
Cheryl Wheeler
Head of Corporate Communications
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