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Collegium Pharmaceutical Inc. Announces Final Study Results of Its Successfully Completed Proof of Concept Study for Its Abuse Deterrent Sustained Release Opioid Product

Posted on: Thursday, 20 December 2007, 09:00 CST

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced detailed study results from its recently completed proof of concept clinical trial for its abuse deterrent, sustained release, oral oxycodone formulation (COL-003). COL-003 is currently in development for the management of moderate to severe pain. The Company had previously reported the top line results of this study. In addition, the Company today announced that the U.S. Federal Drug Administration (FDA) has granted Fast Track Designation for COL-003. Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and demonstrate the potential to address unmet medical needs. Fast track designation enables a sponsor to have more frequent and timely communication with the FDA regarding product development plans and may also result in eligibility for priority review of the New Drug Application.

Product Description

COL-003 contains oxycodone as an active ingredient and utilizes the Company's DETERx™ technology. COL-003 is a sustained release oral dosage form designed to be more resistant to tampering and abuse than traditional formulations of the drug. COL-003 has undergone extensive in vitro testing and has met its development endpoints for dissolution and in vitro abuse simulation testing. Based on these studies COL-003 is expected to provide adequate plasma concentrations to effectively treat pain while deterring abuse by oral administration (e.g. chewing, crushing), intravenous injection and nasal administration (i.e. snorting).

Study Design:

The recently completed open-label, controlled, single dose, cross-over comparison study (CP-OXYDET-01) assessed (1) the safety and pharmacokinetics of single dose administration of two formulations of COL-003 (formulations A and B) as compared to a marketed reference product (OxyContin®) and (2) the influence of a common method of tampering (i.e. chewing) on pharmacokinetics of one formulation of COL-003 (subjects opened the capsules and chewed the contents before administration). All of the treatments were administered to subjects 30 minutes after a meal.

Study Results:

The mean pharmacokinetic parameters for each treatment arm are shown in the table below.

Clinical Trial CP-OXYDET-01

Mean Pharmacokinetic Parameters

Formulation/

Regimen

Cmax (ng/mL)

AUCINF (hr.ng/mL)

COL-003A/

Intact Dosage Form

18.7

215

COL-003A/

Chewed Dosage Forma

18.4

224

COL-003B/

Intact Dosage Form

21.4

239

Reference Product/

Intact Dosage Form

20.5

222

aCapsule contents chewed by subjects for 60 seconds and swallowed with aid of water

Both COL-003A and COL-003B produced a plasma exposure similar to the marketed reference product, OxyContin®, when administered to subjects in a fed state. Trial results indicated that formulation COL-003B was bioequivalent to the reference product (i.e. confidence intervals were within FDA 80-125% limits). In one arm of the study, subjects chewed the COL-003 formulation prior to swallowing as a controlled simulation of misuse. The plasma profile for the chewed dosage form was also bioequivalent to COL-003 when administered whole and as intended, suggesting that misuse by chewing would not result in a spike in plasma level as desired by the abuser.

The Company is in the process of submitting the final study report to the FDA as well as requesting a meeting to discuss the Proof of Concept trial data and its plans for the pivotal clinical program. The Company plans to commence the pivotal clinical program in the second half of 2008.

"The results of the proof of concept trial validate our DETERx delivery platform. Our pre-clinical models were highly predictive of the in vivo activity and this enables us to quickly modify the formulation to achieve the desired pharmacokinetics as well as screen additional molecules incorporated in the DETERx technology. We believe DETERx has broad utility for a variety of drug molecules with and without abuse potential. We intend to accelerate the COL-003 program and to work closely with the FDA to move the product expeditiously through the development process" said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical. "We are pleased that the FDA has recognized that COL-003 may address the public health need for an abuse deterrent sustained release opioid product for the treatment of moderate to severe pain as demonstrated by the granting of fast track designation".

About Collegium Pharmaceutical

Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through formulation based product improvements protected by intellectual property (IP). Collegium focuses on product development in respiratory diseases, CNS disorders, and skin and skin related disorders through its subsidiary, Onset Therapeutics (www.onsettx.com). For more information, visit the Company's website at www.collegiumpharma.com

OxyContin® is a registered trademark of Purdue Pharma

Source: Business Wire

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