Close

Elan Drug Technologies Announces Completion of Enrolment in Phase 3

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Related stories

FDA Plans to Deploy AI Tools for Scientific Reviews

The US Food and Drug Administration has announced plans...

The Ultimate Pain Relief Guide: Proven Tips to Manage Discomfort Naturally

Pain is something that we all go through somehow...

Medical Negligence in 2025: Pharma’s Role in Ensuring Patient Safety

In the ever-evolving world of healthcare, the role of...

When Pharma Meets the Underworld: How Legitimate Drug Supply Chains and Illicit Drug Markets Collide

In today's global landscape, the intersection between legitimate pharmaceutical...

Elan Drug Technologies, a business unit of Elan Corporation, plc announced that Zogenix Inc, its licensee, has completed enrolment in its open-label Phase 3 study (Study 802) of ZX002, a novel, oral, single-entity, controlled-release formulation of hydrocodone. ZX002, which was developed using Elan Drug Technologies’ SODAS® technology, is being studied for the treatment of moderate to severe chronic pain in individuals who require around-the-clock opioid therapy for the control of pain.  The goal of this 12-month study is to evaluate the long-term safety and tolerability of ZX002.  Zogenix is concurrently running a pivotal Phase 3 efficacy study (Study 801) where initial top-line data is expected in the second half of 2011.  At present there are no products available as single-entity, controlled-release formulations of hydrocodone in the United States.  Using Elan Drug Technologies’ SODAS® technology, ZX002, offers a unique, controlled-release profile which utilises both immediate release and extended release properties designed to enable twice daily dosing.

Zogenix expects, pending positive Phase 3 clinical results, to submit an NDA for ZX002 with US Food and Drug Administration (FDA) by early 2012.  The product would be manufactured in Elan Drug Technologies’ DEA approved site at Gainesville, Georgia in the US.

Latest stories

Related stories

FDA Plans to Deploy AI Tools for Scientific Reviews

The US Food and Drug Administration has announced plans...

The Ultimate Pain Relief Guide: Proven Tips to Manage Discomfort Naturally

Pain is something that we all go through somehow...

Medical Negligence in 2025: Pharma’s Role in Ensuring Patient Safety

In the ever-evolving world of healthcare, the role of...

When Pharma Meets the Underworld: How Legitimate Drug Supply Chains and Illicit Drug Markets Collide

In today's global landscape, the intersection between legitimate pharmaceutical...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back