Collegium Announces Poster Presentations at the American Academy of Child & Adolescent Psychiatry and Neuroscience Education Institute Conferences
STOUGHTON, Mass., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (NASDAQ:COLL) today announced it will have 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) in people 6 years of age and older at the American Academy of Child & Adolescent Psychiatry (AACAP) and Neuroscience Education Institute (NEI) conferences.
"We're proud to present new real-world data at both AACAP and NEI during ADHD Awareness Month, underscoring our continued commitment to the ADHD community. These presentations offer meaningful insight into the real-world use of Jornay PM and support our mission to improve care for individuals living with ADHD," said Thomas Smith, M.D., Chief Medical Officer.
AACAP is being held in Chicago, IL from October 20-25, 2025.
| Poster Title: | Determining the Optimal Dose of Methylphenidate HCI (JORNAY PM) in Adolescents and Adults in a Real-World Psychiatric Setting |
| Authors: | Joel Young, MD; Richard Powell, PhD, JD, LPC, CCMHC; Anna Powell, MS; Lauren Granata, PhD; Lisa Welling, PhD; Jaime Saal, MA, LPC, NCC; Margot Nash, MA |
| Date: Time: Location: | Wednesday, October 22 4 – 6 p.m. CDT Hyatt Regency |
NEI Fall Congress is being held in Colorado Springs, CO from November 6-9, 2025.
| Poster Title: | JORNAY PM®in Practice: Real-World Evidence Exploration of Utilization and Patient Response |
| Authors: | Joel Young, MD; Richard Powell, PhD, JD, LPC, CCMHC; Anna Powell, MS; Lauren Granata, PhD; Lisa Welling, PhD; Jaime Saal, MA, LPC, NCC; Margot Nash, MA |
| Date: Time: Location: | Friday, November 7 4 – 5 p.m. MST Broadmoor West, The Broadmoor |
IMPORTANT SAFETY INFORMATION
| 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. |
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, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings (affect lability), increased heart rate, and increased blood pressure.
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, restlessness (psychomotor hyperactivity), headache, nausea, mood swings, and vomiting. 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. JORNAY PM is not recommended for use in children under 6 years of age with ADHD.
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 a rapidly growing neuropsychiatry business. Collegium's strategy includes growing its commercial portfolio, with ADHD 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 current and 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 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 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.
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