Megace® ES

MegaceŽ ES

Case Study 2 – Enhanced patient acceptability – creating a branded opportunity


The Challenge
Par Pharmaceuticals’ (Strativa Pharmaceuticals) product megesterol acetate, which is indicated for the treatment of anorexia, cachexia (severe malnutrition) or an unexplained significant weight loss in patients with AIDS, is a poorly water-soluble compound.


However this compound:
 

  • was a thick viscous liquid that was difficult to swallow
  • required 20ml volume (4 teaspoonfuls) to be taken daily
  • had to be taken with food (for patients with little or no appetite, having to take with food was a significant problem)                


In 2002, Par approached Elan Drug Technologies, with the hope of overcoming the inherent difficulties associated with megesterol acetate. 


Solution Applied
The unique solution applied by Elan Drug Technologies was its NanoCrystal® technology. The NanoCrystal® technology is a formulation and manufacturing approach for improving delivery of poorly water soluble drugs and thus megestrol acetate is an excellent fit with the technology.

NanoCrystal® technology involves reducing the drug to nanometre-sized particles. By reducing particle size, we increase the drug’s exposed surface area. We then stabilise the particles to maintain the formulation’s particle size.  The result - drug is easier to dissolve and absorb. 



Within 36 months, the new product was formulated, underwent extensive testing and clinical trials and was approved by the US Food and Drug Administration. Megace® ES was launched in July 2005, making it Par’s first branded product for sale in the U.S.


Benefit to Patients
By applying our NanoCrystal® solubility enhancing technology, we formulated a superior, more palatable product with a significantly lower dose than the original product where

  • viscosity reduced 16 fold
  • volume swallowed reduced by 75%
  • product could be taken with or without food - a significant benefit for those with poor or no appetite

 



Benefit to Par Pharmaceuticals
Megace® ES is Par’s first branded medication, marking a strategic shift for the company. 
Annual sales are expected to reach US$100million.

 

Megesterol acetate is available for licensing in all territories ex-US.

 

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