July 24, 2014 4:11 AM ET

Pharmaceuticals

Company Overview of Collegium Pharmaceutical, Inc.

Company Overview

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, engages in the development of proprietary late-stage pharmaceutical products that address the problems associated with non-medical use and abuse of prescription drugs through formulation-based improvements. It focuses on developing a portfolio of products for the treatment of chronic pain that possess tamper-resistant features and provide extended-release delivery. The company was founded in 2002 and is based in Canton, Massachusetts.

780 Dedham Street

Suite 800

Canton, MA 02021

United States

Founded in 2002

Phone:

781-713-3699

Key Executives for Collegium Pharmaceutical, Inc.

Co-Founder
Age: 49
Vice President of Business Development
Vice President of Product Development
Vice President of Pharmaceutical Development
Vice President of Clinical Development and Head of Neuroscience Therapeutic Area
Compensation as of Fiscal Year 2014.

Collegium Pharmaceutical, Inc. Key Developments

Collegium Pharmaceutical, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 08:30 AM

Collegium Pharmaceutical, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 08:30 AM. Venue: Grand Hyatt, New York, New York, United States. Speakers: Michael T. Heffernan, Co-Founder, Chief Executive Officer, President and Director.

Collegium Pharmaceutical, Inc. Announces Pre-NDA Meeting with FDA for Oxycodone DETERx(R), its Extended-Release, Abuse-Deterrent Product for the Treatment of Chronic Pain

Collegium Pharmaceutical, Inc. announced that it has successfully concluded its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding Oxycodone DETERx(R), its extended-release (ER), abuse-deterrent, oxycodone microsphere-in-capsule product. The purpose of the meeting was to discuss the non-clinical, clinical and Chemistry, Manufacturing and Controls (CMC) development of Oxycodone DETERx(R), and to agree on the submission requirements for the NDA submission under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Following the meeting, Collegium intends to proceed with its NDA submission as previously announced.

Collegium Pharmaceutical, Inc. Announces Positive Results from Clinical Study Evaluating the Effect of Physical Manipulation by Crushing on Oxycodone DETERx

Collegium Pharmaceutical, Inc. announced positive topline results from a clinical study evaluating the effect of physical manipulation by crushing on Oxycodone DETERx, it's extended-release, abuse-deterrent, oxycodone microsphere-in-capsule product, compared with reformulated OxyContin. Oxycodone DETERx utilizes Collegium's DETERx technology platform; it is designed to be more resistant to tampering and abuse than traditional formulations of the drug and is currently in Phase 3 clinical development. The product's abuse-deterrent characteristics are being evaluated in laboratory and clinical studies, consistent with the 2013 FDA Draft Guidance Abuse-Deterrent Opioids - Evaluation and Labeling. The objective of the recently completed study was to assess the safety and pharmacokinetics of Oxycodone DETERx when the capsule was taken intact after oral administration compared with opening the capsule and crushing the capsule contents (microspheres) prior to oral administration. These treatments were compared with OxyContin intact, OxyContin crushed, and an immediate-release oxycodone tablet formulation crushed in naltrexone-blocked, healthy subjects (n=42). The study was an open label, randomized, active-controlled, 5 treatment, 5 period, cross-over comparison design. The selected crushing techniques were previously identified in the laboratory as the most effective method of reducing the particle size for each respective product. These crushing methods are also commonly employed by abusers to destroy the time-release mechanism of extended-release opioid formulations to make the drug more abusable. The top-line results of the study demonstrated the following: Crushed Oxycodone DETERx(R) capsule contents (microspheres) (Cmax = 62.9 ng/mL) were bioequivalent based upon Cmax and AUC to intact Oxycodone DETERx(R) capsules (Cmax = 67.5 ng/mL) with similar Tmax demonstrating that crushing the contents of Oxycodone DETERx(R) capsules did not alter the pharmacokinetics. Crushed OxyContin(R) tablets (Cmax = 78.4 ng/mL) were bioequivalent based upon Cmax and AUC to crushed IR tablets (Cmax = 79.4 ng/mL), demonstrating that crushing OxyContin compromised the integrity of the time-release formulation, transforming the drug-release profile from an ER profile to an IR profile. At one hour after dosing, crushed OxyContin(R) resulted in an approximately 7 times higher mean plasma concentration than taking OxyContin intact and an approximately 4 times higher mean plasma concentration than crushed Oxycodone DETERx(R). The mean Abuse Quotient was calculated for all treatment arms. The mean AQ value for crushed Oxycodone DETERx(R) was lower than that of Oxycodone DETERx intact. The AQ for crushed OxyContin was approximately 4 times higher than the AQ value for OxyContin(R) intact and similar to the crushed oxycodone IR tablets.

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