Elan Drug Technologies

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Avinza®

Case Study 1 – Once Daily, Novel Dual Release Morphine Sulphate using Elan Drug Technologies’ proprietary SODAS^® Technology 


The Challenge 
Morphine, while a well-known and trusted analgesic….

• has a short half-life
• break-though pain is a significant problem
• no product offered true once daily dosing
• fed fasted variability
• not suitable for monotherapy - did not have a fast onset of action coupled with full day relief             

 
Solution Applied
Formulation and Process Approach
Elan Drug Technologies’ unique solution was its SODAS^® technology. A novel dual release formulation of the narcotic analgesic morphine was developed which differed from other currently marketed formulations because of two unique properties:

1. True once daily controlled release achieved, therapeutic plasma levels maintained for 24 hours
2. An immediate release component enabled a fast onset of action, suitable for monotherapy, thus eliminating the need for fast acting products             

Benefit to Patient
By applying our SODAS^® technology, we developed a superior, unique, patented  product with

• fast onset
• 24 hour sustained pain control in a single daily dose
• steady around the clock analgesia
• ability to titrate with other strengths
• ability to sprinkle on food for easier administration

Mean Steady State Plasma Morphine Concentrations




Benefit to Marketer   
Elan Drug Technologies’ once daily morphine product was launched in 2002 under the trade name Avinza® in the U.S. Avinza® is available in 30mg, 45mg, 60mg, 75mg, 90mg and 120mg capsule strengths and is manufactured in Elan Drug Technologies’ DEA approved manufacturing site in Gainesville Georgia, USA. Avinza® is currently marketed by King Pharmaceuticals. 
 

Unique features included:

• ability to position itself as only true once daily product available in the U.S.
• eliminated fed fasted variations
• patent protected
• convenient administration

 

 In the past four years, in-market sales have exceeded US$100M annually.

 

Our once daily morphine is available for licensing in all territories ex-North America.