Phosphagenics' ($PPGNY) 72-hour oxymorphone transdermal patch is set to enter the clinic next month, in a Phase I trial in Australia's Royal Adelaide Hospital. Results are expected as early as March.
Oxymorphone is a semisynthetic opioid for the management of chronic pain, but oral use is complicated by food effects and problems with bioavailability. The patch uses the Melbourne-based company's TPM (Targeted Penetration Matrix) delivery system to get around the issues of oral dosing, and has been developed to deliver round-the-clock pain control. Phosphagenics' TPM delivery system is designed to deliver small and large molecules as a patch, ointment, gel or oral liquid. Controlling the sizes of the vesicles carrying the drugs can modify the rate at which the active agent is delivered.
Phosphagenics has another TPM pain patch in its portfolio. Its lead oxycodone patch, in development in collaboration with 3M ($MMM), is expected to enter multidose trials this year, and may be the first sustained-release oxycodone patch to reach the market. The oxycodone patch went through some formulation and crystallization issues, but the learning from these has enabled the oxymorphone patch to be developed in just 6 months from concept to clinic.
"Together, these products would be appropriate for tackling all levels of chronic pain indications from opioid naïve to opioid experienced patients," says Phosphagenics' CEO, Esra Ogru.
The U.S. extended release opioid market is large, at around $5 million, and is dominated by oxymorphone and oxycodone, suggesting a major sales opportunity for Phosphagenics and its U.S. commercial development partner Neura Therapeutik, should the patch products reach the market.
- read the press release (pdf)