COLLEGIUM PHARMACEUTICAL, INC
For the period ended May 12, 2026. Filed May 12, 2026.
View on SEC.govAbout this filing
A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
May 12, 2026 · Filed May 12, 2026
Use the contents to explore the available documents and sections.
COLL$24.21-3.8%Stored close · as of Nov 6, 2026
Contents
EX-99.1 · WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS
| · | Risks to patients with serious cardiac disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. |
| · | Increased blood pressure and heart rate: Monitor blood pressure and pulse. |
| · | Psychiatric adverse reactions: Prior to initiating AZSTARYS, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing AZSTARYS |
| · | Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. |
| · | Peripheral vasculopathy, including Raynaud's Phenomenon: Careful observation for digital changes is necessary during AZSTARYS treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy (5.6) |
| · | Long-term suppression of growth in pediatric patients: Monitor height and weight at appropriate intervals in pediatric patients. |
| · | Acute angle closure glaucoma: AZSTARYS-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. |
| · | Increased intraocular pressure (IOP) and glaucoma: Prescribe AZSTARYS to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma. |
| · | Motor and verbal tics, and worsening of Tourette’s syndrome: Before initiating AZSTARYS, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. |
| · | Discontinue treatment if clinically appropriate. |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.