Collegium Pharmaceutical, a specialty pharmaceutical company, has started enrolling subjects with moderate-to-severe chronic lower back pain in placebo-controlled, enriched-enrolment Phase III efficacy study of Oxycodone DETERx (COL-003).

The randomised withdrawal, double-blind, parallel-group, multicentre, 12-week clinical study is designed to compare the safety, efficacy and tolerability of Oxycodone DETERx versus a placebo.

The company’s lead product, COL-003, utilises its DETERx tamper-resistant, extended-release drug delivery technology, which consists of a multi-particulate matrix formulation in a capsule.

Collegium president and CEO Michael Heffernan said that the development programme for Oxycodone DETERx also includes a comprehensive in vitro and in vivo characterisation of the pharmacokinetics and tamper-resistant properties of the drug.

"We are very encouraged by the results to date which suggest that Oxycodone DETERx may offer a number of significant clinical advantages over currently marketed tamper-resistant opioids for the treatment of chronic pain," Heffernan said.

"We expect to complete all of the required studies and submit the NDA by the end of 2013."

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The DETERx drug delivery platform, which features tamper-resistant properties to protect against chewing, crushing, insufflation and extraction for IV injection, even allows patients with difficulty swallowing to open the capsule and administer the contents on food or via a gastronomy tube, while maintaining the extended release properties of the product.

The technology can be used with opioids and amphetamines, as well as drugs with narrow therapeutic windows.