August 30, 2014 6:20 PM 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. Announces Positive Top-Line Results from its Pivotal Phase 3 Study of its Investigational Analgesic Oxycodone DETERx

Collegium Pharmaceutical, Inc. announced positive top-line results from its pivotal Phase 3 study of the company’s investigational analgesic Oxycodone DETERx® that studied the treatment of patients with moderate-to-severe chronic low back pain. The study successfully met the primary efficacy endpoint by showing that patients with chronic low back pain treated with Oxycodone DETERx® experienced a statistically significant reduction in pain compared with placebo (p< 0.0001). In addition, sensitivity analyses of the primary endpoint also achieved statistically significant differences between Oxycodone DETERx® and placebo. The Phase 3 study was a multicenter, double-blind, enriched enrollment, randomized withdrawal, placebo-controlled, safety, tolerability and efficacy study of Oxycodone DETERx® versus placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain. Patients who achieved a stable and effective dose of Oxycodone DETERx® during the open-label Titration Phase were randomized (n=389) into the 12-week, Double-blind Maintenance (treatment) Phase in which they were either maintained on their current dose regimen of Oxycodone DETERx® or were tapered to placebo. The primary efficacy endpoint of the study was the change in average pain intensity from baseline to week 12; pain was measured using an 11-point pain intensity numerical rating scale (PI-NRS). Secondary endpoints in the study included evaluation of safety and tolerability, quality of life, physical disability, and global impression of change. Collegium has also completed an extensive program of abuse-deterrent studies that follow FDA’s 'Abuse-Deterrent Opioids – Evaluation and Labelling' draft guidance published in January 2013. The Oxycodone DETERx® abuse-deterrent program consists of a battery of in vitro studies, in vivo pharmacokinetic studies, and clinical human abuse potential ('HAP') studies. In addition, Collegium has completed all necessary studies to support product labelling, which will instruct patients with difficulty swallowing to open the capsule and administer the contents directly into their mouth, onto food, or via feeding tube, while maintaining the extended-release properties of the product.

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.

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