Collegium Pharmaceutical
Biopharmaceutical company focused on formulation and delivery development for central nervous system (CNS) and pain therapies, and on commercialization and lifecycle management of specialty opioid and CNS products. Activities include development of mucoadhesive buccal film and delayed/extended-release oral dosage forms, clinical research including pediatric studies, population pharmacokinetic and pharmacology assessments, pharmacovigilance and postmarketing safety surveillance, controlled-substance risk-mitigation and patient counseling materials, and supply chain and technical operations to support product quality and distribution. The company markets an evening-dosed delayed+extended-release oral stimulant formulation for ADHD (methylphenidate hydrochloride) for patients 6 years and older that is scheduled as a controlled substance (CII), with specific evening dosing instructions, a sprinkle-on-food administration option, and defined storage and disposal guidance.
Industries
Nr. of Employees
large (251-1000)
Collegium Pharmaceutical
Patents
Products
Evening-dosed delayed + extended-release methylphenidate capsule (chronotherapeutic oral stimulant)
Oral capsule formulation containing methylphenidate hydrochloride intended for treatment of ADHD in patients 6 years and older. Formulation is designed for evening administration to provide morning and daytime symptom control; recommended dosing window for evening administration is between 6:30 p.m. and 9:30 p.m. Capsules may be swallowed whole or opened and the full dose sprinkled onto soft food (e.g., applesauce) and consumed immediately without chewing. The product is a federally controlled substance (Schedule CII); labeling includes safe storage (room temperature 20°C to 25°C / 68°F to 77°F), disposal instructions (DEA-authorized take-back or household disposal procedures when authorized), contraindications (e.g., recent MAOI use), drug interaction warnings, common adverse events, and pregnancy registry information for exposures during pregnancy.
Buccal-transmucosal opioid film (mucoadhesive buccal film analgesic)
Mucoadhesive buccal film formulation of an opioid analgesic for management of severe, persistent pain requiring daily opioid therapy; includes dosing and administration instructions for buccal application, drug interaction and safety guidance, and risk-mitigation counseling materials.
Immediate-release and extended-release oral opioid analgesic tablets
Oral immediate-release and extended-release tablet formulations of a centrally-acting opioid analgesic with prescribing information covering dosing, safety, pediatric use, pharmacokinetics, drug interactions, and postmarketing adverse reactions.
ADHD stimulant product with prescribing and patient materials
Prescription medication for attention-deficit/hyperactivity disorder with supporting prescribing information and patient materials covering indications, dosing, and safety monitoring.
GI-targeted prescription medication with prescribing information
Prescription medication for specified gastrointestinal indications with prescribing information and safety guidance.
Evening-dosed delayed + extended-release methylphenidate capsule (chronotherapeutic oral stimulant)
Oral capsule formulation containing methylphenidate hydrochloride intended for treatment of ADHD in patients 6 years and older. Formulation is designed for evening administration to provide morning and daytime symptom control; recommended dosing window for evening administration is between 6:30 p.m. and 9:30 p.m. Capsules may be swallowed whole or opened and the full dose sprinkled onto soft food (e.g., applesauce) and consumed immediately without chewing. The product is a federally controlled substance (Schedule CII); labeling includes safe storage (room temperature 20°C to 25°C / 68°F to 77°F), disposal instructions (DEA-authorized take-back or household disposal procedures when authorized), contraindications (e.g., recent MAOI use), drug interaction warnings, common adverse events, and pregnancy registry information for exposures during pregnancy.
Buccal-transmucosal opioid film (mucoadhesive buccal film analgesic)
Mucoadhesive buccal film formulation of an opioid analgesic for management of severe, persistent pain requiring daily opioid therapy; includes dosing and administration instructions for buccal application, drug interaction and safety guidance, and risk-mitigation counseling materials.
Immediate-release and extended-release oral opioid analgesic tablets
Oral immediate-release and extended-release tablet formulations of a centrally-acting opioid analgesic with prescribing information covering dosing, safety, pediatric use, pharmacokinetics, drug interactions, and postmarketing adverse reactions.
ADHD stimulant product with prescribing and patient materials
Prescription medication for attention-deficit/hyperactivity disorder with supporting prescribing information and patient materials covering indications, dosing, and safety monitoring.
GI-targeted prescription medication with prescribing information
Prescription medication for specified gastrointestinal indications with prescribing information and safety guidance.
Services
Centralized medical information contact and adverse event reporting channels for healthcare professionals and patients; management of safety inquiries, pharmacovigilance case collection, evaluation, and regulatory reporting.
Administration of grants and support for independent medical education and investigator-initiated studies to inform clinical practice and generate real-world evidence.
Centralized medical information contact and adverse event reporting channels for healthcare professionals and patients; management of safety inquiries, pharmacovigilance case collection, evaluation, and regulatory reporting.
Administration of grants and support for independent medical education and investigator-initiated studies to inform clinical practice and generate real-world evidence.
Expertise Areas
- Transmucosal drug delivery (buccal film development)
- Immediate- and extended-release oral formulation development
- Chronotherapeutic formulation design for evening-dosed oral capsules
- Clinical trial design and execution for pain and CNS indications (adult and pediatric)
Key Technologies
- Transmucosal buccal film delivery
- Delayed-plus-extended-release oral capsule technology
- Extended-release oral dosage technologies (delayed and extended-release coatings)
- Population pharmacokinetic (popPK) modeling
News & Updates
Press release announcing date for third quarter 2026 financial results.
Press release about planned presentations of pediatric and real-world research related to the ADHD portfolio.
Press release describing a program providing practical support for families regarding ADHD care and school navigation.
Press release announcing date for third quarter 2026 financial results.
Press release about planned presentations of pediatric and real-world research related to the ADHD portfolio.
Press release describing a program providing practical support for families regarding ADHD care and school navigation.