Oxycodone is an opioid drug which is more potent than morphine, and demonstrates fewer adverse effects in patients. Consequentially, it is a leading pain management drug for the treatment of moderate to severe pain. It is currently administered in tablet or intravenous form.
Global opioid revenue for 2010 has been forecast to be in excess of USD 10.5 billion. The superior properties of oxycodone in pain relief resulted in an almost 900% increase in patient use in the decade to 2007. Oxycodone-based drugs generate revenues in excess of $4-5 billion per annum, with Oxycontin alone posting sales of approximately $3.88 billion in 2010.
Phosphagenics is working towards becoming the first to provide chronic pain sufferers with a patch that will provide sustained-release of oxycodone into the bloodstream. Clinical trials to date have demonstrated that Phosphagenics’ novel technology can effectively deliver opiates through the skin without causing irritation. A transdermal product is desirable to reduce or eliminate GI tract side effects, and achieve a sustained therapeutic profile. A further advantage of a matrix patch is the opportunity to produce an abuse resistant product.
The TPM/oxycodone patch has been designed using a polymer matrix that makes drug extraction inherently difficult. Anti-abuse properties are critical in order to gain acceptance from registration authorities and regulatory bodies such as the FDA.
Phosphagenics conducted three clinical studies between 2009-2010 on its TPM/oxycodone formulation, both with successful results. The first study, an open-label, human Repeat Insult Patch Test (RIPT) evaluated the skin response of fifty healthy participants with both an induction phase and a challenge phase. The study concluded that no significant erythema or sensitization were observed.
The second study, a Repeat Dose Application study, was an open label, single centre pharmacokinetic study in 20 healthy volunteers conducted at the Royal Adelaide Hospital. Its primary objective was to compare the delivery profiles of two transdermal patch candidates containing TPM®, a matrix and a reservoir system, following daily application over a ten-day period. The study reported positive results using the company’s proprietary TPM® (Targeted Penetration Matrix) technology for the transdermal delivery of oxycodone and revealed that daily application of the TPM/oxycodone patch delivered therapeutic bloodstream levels of oxycodone in a reproducible, consistent and sustained manner, again with no irritation observed.
A third study, completed in October 2010, was led by Professor Guy Ludbrook at the Royal Adelaide Hospital. This milestone study was designed to compare various dosage regimes of the TPM/oxycodone patch. Importantly, the study demonstrated that the extended dosing period of 14 days enabled steady state delivery of oxycodone into the bloodstream to be achieved.
In November 2010 Phosphagenics announced signing a collaborative consultancy agreement with 3M for the optimisation and development of a commercial scale up manufacturing process.
3M’s expertise in drug delivery technologies has assisted Phosphagenics to improve the delivery profile of the original patch prototype by five-fold. The latest positive development only further enhances Phosphagenics commercialisation pathway for the world-first oxycodone-based pain patch.
The next stages of the commercialisation pathway for TPM/oxycodone will be the recruitment and commencement of the clinical trials throughout 2011 and 2012 for pivotal late phase trials. With a top level steering committee also on-board, the future outlook and commercial prospects for the TPM/oxycodone pain patch bodes well for Phosphagenics.
The Phase 3 clinical trials are anticipated to be completed by 2013, following this Phosphagenics would seek market approval and product registration.